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The Cochrane Database of Systematic... Mar 2023Phototherapy is a widely accepted, effective first-line therapy for neonatal jaundice. It is traditionally used continuously but intermittent phototherapy has been... (Review)
Review
BACKGROUND
Phototherapy is a widely accepted, effective first-line therapy for neonatal jaundice. It is traditionally used continuously but intermittent phototherapy has been proposed as an equally effective alternative with practical advantages of improved maternal feeding and bonding. The effectiveness of intermittent phototherapy compared with continuous phototherapy is unknown.
OBJECTIVES
To assess the safety and effectiveness of intermittent phototherapy compared with continuous phototherapy.
SEARCH METHODS
Searches were conducted on 31 January 2022 in the following databases: CENTRAL via CRS Web, MEDLINE and Embase via Ovid. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials.
SELECTION CRITERIA
We included RCTs, cluster-RCTs and quasi-RCTs comparing intermittent phototherapy with continuous phototherapy in jaundiced infants (both term and preterm) up to the age of 30 days. We compared intermittent phototherapy with continuous phototherapy by any method and at any dose and duration as defined by the authors.
DATA COLLECTION AND ANALYSIS
Three review authors independently selected trials, assessed trial quality and extracted data from included studies. We performed fixed-effect analyses and expressed treatment effects as mean difference (MD), risk ratio (RR) and risk difference (RD) with 95% confidence intervals (CIs). Our primary outcomes of interest were rate of decline of serum bilirubin, and kernicterus. We used the GRADE approach to assess the certainty of evidence.
MAIN RESULTS
We included 12 RCTs (1600 infants) in the review. There is one ongoing study and four awaiting classification. There was little or no difference between intermittent phototherapy and continuous phototherapy with respect to rate of decline of bilirubin in jaundiced newborn infants (MD -0.09 micromol/L/hr, 95% CI -0.21 to 0.03; I² = 61%; 10 studies; 1225 infants; low-certainty evidence). One study involving 60 infants reported no incidence of bilirubin induced brain dysfunction (BIND). It is uncertain whether either intermittent or continuous phototherapy reduces BIND because the certainty of this evidence is very low. There was little or no difference in treatment failure (RD 0.03, 95% CI 0.08 to 0.15; RR 1.63, 95% CI 0.29 to 9.17; 1 study; 75 infants; very low-certainty evidence) or infant mortality (RD -0.01, 95% CI -0.03 to 0.01; RR 0.69, 95% CI 0.37 to 1.31 I² = 0%; 10 studies, 1470 infants; low-certainty evidence). AUTHORS' CONCLUSIONS: The available evidence detected little or no difference between intermittent and continuous phototherapy with respect to rate of decline of bilirubin. Continuous phototherapy appears to be more effective in preterm infants, however, the risks of continuous phototherapy and the potential benefits of a slightly lower bilirubin level are unknown. Intermittent phototherapy is associated with a decrease in the total number of hours of phototherapy exposure. There are theoretical benefits to intermittent regimens but there are important safety outcomes that were inadequately addressed. Large, well designed, prospective trials are needed in both preterm and term infants before it can be concluded that intermittent and continuous phototherapy regimens are equally effective.
Topics: Infant; Infant, Newborn; Humans; Jaundice, Neonatal; Phototherapy; Bilirubin; Family
PubMed: 36867730
DOI: 10.1002/14651858.CD008168.pub2 -
The Cochrane Database of Systematic... Jan 2010Primary sclerosing cholangitis is a chronic cholestatic disease of intrahepatic and extrahepatic biliary ducts, characterised by chronic periductal inflammation and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Primary sclerosing cholangitis is a chronic cholestatic disease of intrahepatic and extrahepatic biliary ducts, characterised by chronic periductal inflammation and sclerosis of the ducts, which results in segmental stenoses of bile ducts, cholestasis, fibrosis, and ultimately, liver cirrhosis. Patients with primary sclerosing cholangitis are at higher risk of cholangiocarcinoma as well as of colonic neoplasia, since primary sclerosing cholangitis is associated with inflammatory bowel disease in more than 80% of the patients. Several therapeutic modalities have been proposed for primary sclerosing cholangitis, like ursodeoxycholic acid, glucocorticosteroids, and immunomodulatory agents, but none has been successful in reversing the process of the disease. To date, liver transplantation is the only definite therapeutic solution for patients with advanced primary sclerosing cholangitis with liver cirrhosis.
OBJECTIVES
To assess the beneficial and harmful effects of glucocorticosteroids for patients with primary sclerosing cholangitis.
SEARCH STRATEGY
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, and LILACS from their inception until September 2009, as well as reference lists.
SELECTION CRITERIA
Randomised clinical trials comparing any dose or duration of glucocorticosteroids versus placebo, no intervention, or other immunosuppressive agents. We included trials irrespective of language, blinding, or publication status.
DATA COLLECTION AND ANALYSIS
Authors extracted data independently and assessed the methodological quality by the generation of the allocation sequence, allocation concealment, double blinding, follow-up, incomplete outcome data reporting, selective reporting, baseline imbalance, and early stopping. The results of the meta-analyses were presented as relative risks (RR) or mean difference (MD), both with 95% confidence intervals (CI). The primary outcome measures were mortality and liver-related morbidity.
MAIN RESULTS
Two randomised clinical trials were eligible for inclusion. One trial compared biliary lavage with hydrocortisone versus saline in 17 patients. Hydrocortisone tended to increase adverse events (pancreatitis, cholangitis with septicaemia, paranoid ideas, fluid retention) (RR 3.43, 95% CI 0.51 to 22.9) and had no cholangiographic improvement, which led to termination of the trial. The other trial compared budesonide versus prednisone in 18 patients. Patients had statistically significant higher serum bilirubin concentration after treatment with prednisone compared with budesonide (MD 10.4 micromol/litre, 95% CI 1.16 to 19.64 micromol/litre). No other statistically significant effects on clinical or biochemical outcomes were reported on any of the evaluated interventions.
AUTHORS' CONCLUSIONS
There is no evidence to support or refute peroral glucocorticosteroids for patients with primary sclerosing cholangitis. The intrabiliary application of corticosteroids via nasobiliary tube seems to induce severe adverse effects.
Topics: Anti-Inflammatory Agents; Budesonide; Cholangitis, Sclerosing; Humans; Hydrocortisone; Prednisone; Randomized Controlled Trials as Topic; Therapeutic Irrigation
PubMed: 20091555
DOI: 10.1002/14651858.CD004036.pub3 -
Journal of Dairy Science Jan 2009Soils in many regions of the world have a low Se content. Consequently, forages and crops grown on these soils may provide inadequate dietary Se for humans and grazing... (Meta-Analysis)
Meta-Analysis Review
Soils in many regions of the world have a low Se content. Consequently, forages and crops grown on these soils may provide inadequate dietary Se for humans and grazing animals. Selenium supplementation has been used to enhance Se status and milk Se concentration, but results conflict. Milk Se concentration appears to be a useful indicator of animal and herd Se status, and reflects the responsiveness to supplementation. A systematic review and meta-analysis were carried out to summarize all available scientific evidence for the effect of oral Se supplementation on milk Se concentration in cattle. The literature search was based on electronic and nonelectronic databases. Fixed- and random-effects models of meta-analysis were used, and a meta-regression was carried out to evaluate heterogeneity among studies. Random-effects meta-analysis was performed on 42 studies published between 1977 and 2007. Oral Se supplementation resulted in an average increase in milk Se content of 0.16 (95% confidence interval: 0.117, 0.207) micromol/L, with a significant heterogeneity among studies. Weak publication bias was evident, but it did not change the average effect. The continent where the study was performed, Se source, Se dose, and the interaction between source and dose explained 71% of the between-study variance. On average, American cows supplemented with Se yeast (e.g., 6 mg/h per day) had greater milk Se concentrations (approximately 0.37 micromol/L) 75 d after the beginning of supplementation when compared with those supplemented with inorganic forms of Se. This information provides a basis for tailoring daily animal requirements and for enhancing the Se intake of consumers of dairy products.
Topics: Animals; Cattle; Dietary Supplements; Female; Milk; Publication Bias; Regression Analysis; Selenium
PubMed: 19109290
DOI: 10.3168/jds.2008-1545 -
Clinical Endocrinology May 2009Elevated circulating androgens are risk factors for several chronic, metabolic and reproductive disorders. Metformin is an insulin-sensitizing agent that may lower... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Elevated circulating androgens are risk factors for several chronic, metabolic and reproductive disorders. Metformin is an insulin-sensitizing agent that may lower androgen levels. To evaluate the effects of metformin on endogenous androgens and SHBG levels in women, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing metformin with placebo or no treatment.
DATA SOURCE
We used OVID to search MEDLINE, EMBASE and CENTRAL until March 2007.
REVIEW METHODS
Two reviewers independently extracted data on methodological quality, participants, interventions and outcomes of interest. Our a priori primary outcome was post-treatment measurements. In a secondary analysis, we evaluated the difference between the pre- and post-treatment levels. We computed the weighted mean difference (WMD) as a measure of effect for each outcome using the DerSimonian-Laird random effects method. We used the I2 statistic to assess heterogeneity and explored its causes in subgroup analyses of features related to participants' characteristics and study design. Based on a regression model, we conducted sensitivity analyses by investigating the use of placebo as a predictor of effect size.
RESULTS
Twenty RCTs fulfilled the inclusion criteria. Pooled WMDs in post-treatment levels between the metformin and control group were -0.31 nmol/l (95% CI -0.65 to 0.03) for total testosterone (TT), 0.10 pmol/l (95% CI -0.89 to 1.10) for free testosterone (FT), 0.14 micromol/l (95% CI -0.34 to 0.62) for dehydroepiandrosteronesulfate (DHEAS), -0.60 nmol/l (95% CI -1.67 to 0.46) for androstenedione (AND) and 5.88 nmol/l (95% CI 2.01-9.75) for SHBG. Pooled WMDs of the pre- to post-treatment differences (i.e. with adjustment for baseline hormone levels) were -0.38 (95% CI -0.51 to -0.25) for TT, -2.71 (95% CI -10.35 to 4.93) for FT, -0.50 (95% CI -0.83 to -0.16) for DHEAS, -1.39 (95% CI -2.30 to -0.49) for AND and 6.63 (95% CI 2.32-10.94) for SHBG. In subgroup analyses, features related to the administered treatment (i.e. metformin as a single agent or as part of combined regimens) partly explained the heterogeneity. Sensitivity analyses of studies using placebo showed similar results to those not using placebo.
CONCLUSIONS
Our systematic review and meta-analysis provides evidence of metformin-induced changes in circulating androgens and SHBG levels in women but the quality of evidence is not high. However, there are no data from RCTs regarding these effects in postmenopausal women or healthy premenopausal women. High-quality RCTs are required to evaluate whether metformin has effects on surrogate markers and patient-important outcomes in these patient groups.
Topics: Androgens; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemic Agents; Insulin Resistance; Metformin; Obesity; Polycystic Ovary Syndrome; Randomized Controlled Trials as Topic; Risk Factors; Sex Hormone-Binding Globulin
PubMed: 19178532
DOI: 10.1111/j.1365-2265.2008.03459.x -
Heart (British Cardiac Society) Feb 2006To determine whether dietary supplementation with alpha linolenic acid (ALA) can modify established and emerging cardiovascular risk markers. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To determine whether dietary supplementation with alpha linolenic acid (ALA) can modify established and emerging cardiovascular risk markers.
DESIGN
Systematic review and meta-analysis of randomised controlled trials identified by a search of Medline, Embase, Cochrane Controlled Trials Register (CENTRAL), and the metaRegister of Controlled Trials (mRCT).
PATIENTS
All human studies were reviewed.
MAIN OUTCOME MEASURES
Changes in concentrations of total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, triglyceride, fibrinogen, and fasting plasma glucose, and changes in body mass index, weight, and systolic and diastolic blood pressure.
RESULTS
14 studies with minimum treatment duration of four weeks were reviewed. ALA had a significant effect on three of the 32 outcomes examined in these studies. Concentrations of fibrinogen (0.17 micromol/l, 95% confidence interval (CI) -0.30 to -0.04, p = 0.01) and fasting plasma glucose (0.20 mmol/l, 95% CI -0.30 to -0.10, p < 0.01) were reduced. There was a small but clinically unimportant decrease in HDL (0.01 mmol/l, 95% CI -0.02 to 0.00, p < 0.01). Treatment with ALA did not significantly modify total cholesterol, triglycerides, weight, body mass index, LDL, diastolic blood pressure, systolic blood pressure, VLDL, and apolipoprotein B.
CONCLUSIONS
Although ALA supplementation may cause small decreases in fibrinogen concentrations and fasting plasma glucose, most cardiovascular risk markers do not appear to be affected. Further trials are needed, but dietary supplementation with ALA to reduce cardiovascular disease cannot be recommended.
Topics: Blood Glucose; Blood Pressure; Body Weight; Cardiovascular Diseases; Cholesterol; Dietary Supplements; Fibrinogen; Humans; Risk Factors; Triglycerides; alpha-Linolenic Acid
PubMed: 15890766
DOI: 10.1136/hrt.2004.053538 -
BMJ (Clinical Research Ed.) May 2004To assess the effects of non-absorbable disaccharides (lactulose and lactitol) in patients with hepatic encephalopathy. (Comparative Study)
Comparative Study Review
OBJECTIVE
To assess the effects of non-absorbable disaccharides (lactulose and lactitol) in patients with hepatic encephalopathy.
DATA SOURCES
Cochrane Hepato-Biliary Group controlled trials register, Cochrane Library, Medline, and Embase until March 2003; reference lists of relevant articles; authors and pharmaceutical companies.
REVIEW METHODS
Randomised trials that compared non-absorbable disaccharides with placebo, no intervention, or antibiotics for hepatic encephalopathy were included. The primary outcome measures were no improvement of hepatic encephalopathy and all cause mortality.
RESULTS
22 trials were included. Compared with placebo or no intervention, non-absorbable disaccharides seemed to reduce the risk of no improvement in patients with hepatic encephalopathy (relative risk 0.62, 95% confidence interval 0.46 to 0.84, six trials). However, high quality trials found no significant effect (0.92, 0.42 to 2.04, two trials). Compared with placebo or no intervention, non-absorbable disaccharides had no significant effect on mortality (0.41, 0.02 to 8.68, four trials). Non-absorbable disaccharides were inferior to antibiotics in reducing the risk of no improvement (1.24, 1.02 to 1.50, 10 trials) and lowering blood ammonia concentration (weighted mean difference 2.35 micromol/l, 0.06 micromol/l to 13.45 micromol/l, 10 trials). There was no significant difference in mortality (0.90, 0.48 to 1.67, five trials).
CONCLUSIONS
There is insufficient evidence to support or refute the use of non-absorbable disaccharides for hepatic encephalopathy. Antibiotics were superior to non-absorbable disaccharides in improving hepatic encephalopathy, but it is unclear whether this difference is clinically important. Non-absorbable disaccharides should not serve as comparator in randomised trials on hepatic encephalopathy.
Topics: Anti-Infective Agents; Gastrointestinal Agents; Hepatic Encephalopathy; Humans; Lactulose; Randomized Controlled Trials as Topic; Sugar Alcohols; Treatment Outcome
PubMed: 15054035
DOI: 10.1136/bmj.38048.506134.EE -
The Cochrane Database of Systematic... Jan 2010Interleukin 2 receptor antagonists (IL2Ra) are used as induction therapy for prophylaxis against acute rejection in kidney transplant recipients. Use of IL2Ra has... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Interleukin 2 receptor antagonists (IL2Ra) are used as induction therapy for prophylaxis against acute rejection in kidney transplant recipients. Use of IL2Ra has increased steadily since their introduction, but the proportion of new transplant recipients receiving IL2Ra differs around the globe, with 27% of new kidney transplant recipients in the United States, and 70% in Australasia receiving IL2Ra in 2007.
OBJECTIVES
To systematically identify and summarise the effects of using an IL2Ra, as an addition to standard therapy, or as an alternative to another immunosuppressive induction strategy.
SEARCH STRATEGY
We searched the Cochrane Renal Group's specialised register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE to identify new records, and authors of included reports were contacted for clarification where necessary.
SELECTION CRITERIA
Randomised controlled trials (RCTs) in all languages comparing IL2Ra to placebo, no treatment, other IL2Ra or other antibody therapy.
DATA COLLECTION AND ANALYSIS
Data was extracted and assessed independently by two authors, with differences resolved by discussion. Dichotomous outcomes are reported as relative risk (RR) and continuous outcomes as mean difference (MD) with 95% confidence intervals (CI).
MAIN RESULTS
We included 71 studies (306 reports, 10,537 participants). Where IL2Ra were compared with placebo (32 studies; 5,784 patients) graft loss including death with a functioning graft was reduced by 25% at six months (16 studies: RR 0.75, 95% CI 0.58 to 0.98) and one year (24 studies: RR 0.75, 95% CI 0.62 to 0.90), but not beyond this. At one year biopsy-proven acute rejection was reduced by 28% (14 studies: RR 0.72, 95% CI 0.64 to 0.81), and there was a 19% reduction in CMV disease (13 studies: RR 0.81, 95% CI 0.68 to 0.97). There was a 64% reduction in early malignancy within six months (8 studies: RR 0.36, 95% CI 0.15 to 0.86), and creatinine was lower (7 studies: MD -8.18 micromol/L 95% CI -14.28 to -2.09) but these differences were not sustained.When IL2Ra were compared to ATG (16 studies, 2211 participants), there was no difference in graft loss at any time point, or for acute rejection diagnosed clinically, but the was benefit of ATG therapy over IL2Ra for biopsy-proven acute rejection at one year (8 studies:, RR 1.30 95% CI 1.01 to 1.67), but at the cost of a 75% increase in malignancy (7 studies: RR 0.25 95% CI 0.07 to 0.87) and a 32% increase in CMV disease (13 studies: RR 0.68 95% CI 0.50 to 0.93). Serum creatinine was significantly lower for IL2Ra treated patients at six months (4 studies: MD -11.20 micromol/L 95% CI -19.94 to -2.09). ATG patients experienced significantly more fever, cytokine release syndrome and other adverse reactions to drug administration and more leucopenia but not thrombocytopenia. There were no significant differences in outcomes according to cyclosporine or tacrolimus use, azathioprine or mycophenolate, or to the study populations baseline risk for acute rejection. There was no evidence that effects were different according to whether equine or rabbit ATG was used.
AUTHORS' CONCLUSIONS
Given a 38% risk of rejection, per 100 recipients compared with no treatment, nine recipients would need treatment with IL2Ra to prevent one recipient having rejection, 42 to prevent one graft loss, and 38 to prevent one having CMV disease over the first year post-transplantation. Compared with ATG treatment, ATG may prevent some experiencing acute rejection, but 16 recipients would need IL2Ra to prevent one having CMV, but 58 would need IL2Ra to prevent one having malignancy. There are no apparent differences between basiliximab and daclizumab. IL2Ra are as effective as other antibody therapies and with significantly fewer side effects.
Topics: Creatinine; Cytomegalovirus Infections; Glomerular Filtration Rate; Graft Rejection; Humans; Immunosuppressive Agents; Kidney Transplantation; Randomized Controlled Trials as Topic; Receptors, Interleukin-2
PubMed: 20091551
DOI: 10.1002/14651858.CD003897.pub3 -
BMC Cardiovascular Disorders Sep 2008Experimental and epidemiological evidence suggests that homocysteine (tHcy) may be a causal risk factor for atherosclerosis. B-vitamin supplements reduce tHcy and... (Meta-Analysis)
Meta-Analysis Randomized Controlled Trial Review
The effect of long-term homocysteine-lowering on carotid intima-media thickness and flow-mediated vasodilation in stroke patients: a randomized controlled trial and meta-analysis.
BACKGROUND
Experimental and epidemiological evidence suggests that homocysteine (tHcy) may be a causal risk factor for atherosclerosis. B-vitamin supplements reduce tHcy and improve endothelial function in short term trials, but the long-term effects of the treatment on vascular structure and function are unknown.
METHODS
We conducted a sub-study of VITATOPS, a randomised, double-blind, placebo-controlled intervention trial designed to test the efficacy of long term B-vitamin supplementation (folic acid 2 mg, vitamin B6 25 mg and vitamin B12 0.5 mg) in the prevention of vascular events in patients with a history of stroke. We measured carotid intima-medial thickness (CIMT) and flow-mediated dilation (FMD) at least two years after randomisation in 162 VITATOPS participants. We also conducted a systematic review and meta-analysis of studies designed to test the effect of B-vitamin treatment on CIMT and FMD.
RESULTS
After a mean treatment period of 3.9 +/- 0.9 years, the vitamin-treated group had a significantly lower mean plasma homocysteine concentration than the placebo-treated group (7.9 micromol/L, 95% CI 7.5 to 8.4 versus 11.8 micromol/L, 95% CI 10.9 to 12.8, p < 0.001). Post-treatment CIMT (0.84 +/- 0.17 mm vitamins versus 0.83 +/- 0.18 mm placebo, p = 0.74) and FMD (median of 4.0%, IQR 0.9 to 7.2 vitamins versus 3.0%, IQR 0.6 to 6.6 placebo, p = 0.48) did not differ significantly between groups. A meta-analysis of published randomised data, including those from the current study, suggested that B-vitamin supplements should reduce CIMT (-0.10 mm, 95% CI -0.20 to -0.01 mm) and increase FMD (1.4%, 95% CI 0.7 to 2.1%). However, the improvement in endothelial function associated with homocysteine-lowering treatment was significant in short-term studies but not in longer trials.
CONCLUSION
Although short-term treatment with B-vitamins is associated with increased FMD, long-term homocysteine-lowering did not significantly improve FMD or CIMT in people with a history of stroke.
Topics: Aged; Carotid Arteries; Dietary Supplements; Double-Blind Method; Down-Regulation; Drug Combinations; Female; Folic Acid; Homocysteine; Humans; Male; Middle Aged; Regional Blood Flow; Stroke; Time Factors; Treatment Outcome; Tunica Intima; Tunica Media; Vasodilation; Vitamin B 12; Vitamin B 6; Vitamin B Complex
PubMed: 18803866
DOI: 10.1186/1471-2261-8-24 -
The Cochrane Database of Systematic... 2002Indomethacin therapy for closure of patent ductus arteriosus frequently causes oliguria, and occasionally more serious renal dysfunction. Low dose dopamine has been... (Review)
Review
BACKGROUND
Indomethacin therapy for closure of patent ductus arteriosus frequently causes oliguria, and occasionally more serious renal dysfunction. Low dose dopamine has been suggested as a means for preventing this side effect.
PRIMARY OBJECTIVE
To determine whether dopamine therapy may prevent indomethacin-mediated deterioration in renal function in the preterm newborn infant without serious adverse effects.
SECONDARY OBJECTIVE
To assess the effects of dopamine on the above variables in two subgroups: (1) patients given indomethacin as prophylaxis of intraventricular hemorrhage, and (2) patients given indomethacin as treatment of patent ductus arteriosus
SEARCH STRATEGY
Standard methods of the Cochrane Neonatal Review Group (CNRG) were used. We searched MEDLINE (1966-2001) using PubMed as the search engine, EMBASE (1974-2001) and the Cochrane Controlled Trials Register (CCTR) from the Cochrane Library (Issue 3, 2001). In addition we contacted the principal investigators if necessary to ascertain the required information.
SELECTION CRITERIA
Randomized or quasi-randomized studies of the effects of dopamine on urine output, glomerular filtration rate, fluid balance or incidence of renal failure, in preterm newborn infants receiving indomethacin. The comparison group should have received no dopamine.
DATA COLLECTION AND ANALYSIS
We used the standard methods of the Cochrane Collaboration and those of the CNRG. The primary outcomes of interest were: mortality before discharge; intraventricular hemorrhage, grade three or four; cystic periventricular leukomalacia; renal failure (either oliguria, defined as a urine output less than 1 ml/kg/hour or an elevation in creatinine by more than 40 micromoles/L); failure to close the ductus arteriosus; need for surgical PDA ligation. For categorical outcomes, we calculated typical estimates for relative risk and risk difference. For continuous outcomes the weighted mean difference (WMD) was calculated. Fixed effect models were assumed for meta-analysis.
MAIN RESULTS
Three studies were found (total number randomized patients, 75) which fulfilled the entry criteria for this review. All were single center trials which enrolled NICU patients receiving indomethacin for symptomatic patent ductus arteriosus. There are no (or only partial) results for effects of dopamine on several of the primary outcomes, including death before discharge, serious intraventricular hemorrhage, cystic periventricular leukomalacia, or renal failure. There has been inadequate investigation of the effects of dopamine on cerebral perfusion or cardiac output, or GI complications, or endocrine toxicity. Dopamine improved urine output [WMD 0.68 ml/kg/hour (95% CI 0.22, 1.44)], but there was no evidence of effect on serum creatinine (WMD 2.04 micromoles/liter, CI -17.90, 21.97) or the incidence of oliguria (urine output < 1 ml/kg/hour) (RR 0.73, CI 0.35, 1.54). There was no evidence of effect of dopamine on the frequency of failure to close the ductus arteriosus (RR 1.11, CI 0.56, 2.19).
REVIEWER'S CONCLUSIONS
There is no evidence from randomized trials to support the use of dopamine to prevent renal dysfunction in indomethacin-treated preterm infants.
Topics: Cardiovascular Agents; Dopamine; Ductus Arteriosus, Patent; Humans; Indomethacin; Infant, Newborn; Infant, Premature; Renal Agents; Renal Insufficiency
PubMed: 12137683
DOI: 10.1002/14651858.CD003213 -
Journal of Vascular Surgery Nov 2006The aims of the present study were to (1) analyze preoperative predictors for outcome suggested by Hardman and surgical mortality after open repair and endovascular... (Review)
Review
BACKGROUND
The aims of the present study were to (1) analyze preoperative predictors for outcome suggested by Hardman and surgical mortality after open repair and endovascular repair (EVAR) of ruptured abdominal aortic aneurysms (rAAA), and (2) further evaluate the Hardman index in a systematic review.
METHODS
Patients operated on for rAAA during a 5-year period between 2000 and 2004 were scored according to Hardman-1 point for either age >76 years, loss of consciousness after presentation, hemoglobin <90 g/L, serum creatinine >190 micromol/L or electrocardiographic (ECG) signs of ischemia-with blinded evaluation of ECGs by a specialist in clinical physiology. The results were included in a systematic review of studies evaluating the Hardman index.
RESULTS
In-hospital mortality after operation was 41% (67/162). There was no difference in in-hospital mortality between open repair (n = 106) and EVAR (n = 56), whereas the Hardman index was associated with operative mortality in our institution and in the systematic review of 970 patients (P < .001). Mortality rate in patients with Hardman index > or =3 was 77% in the pooled analysis. A full data set of all five scoring variables was obtained in 94 (58%) of 162 patients in our study, and potential underscoring was thus possible in 68 patients. Of the available ECGs, 12 (8.7%) of 138 were judged nondiagnostic. Five studies did not state their missing data on ECG and hemoglobin and serum creatinine concentrations, nor did they specify the criteria for ECG ischemia.
CONCLUSIONS
A strong correlation between the Hardman index and mortality was found. A Hardman index > or =3 cannot be used as an absolute limit for denial of surgery. The utility of the Hardman index seems to be impeded by variability in scoring resulting from missing or nondiagnostic data.
Topics: Aneurysm, Ruptured; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis Implantation; Hospital Mortality; Humans; Prognosis; Rupture, Spontaneous; Survival Rate; Sweden; Tomography, X-Ray Computed
PubMed: 17098525
DOI: 10.1016/j.jvs.2006.07.041