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Journal of Diabetes Science and... Aug 2015This study sought to assess the function and delivery reliability of intradermal (ID) infusion sets used with commercial insulin pumps. (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
This study sought to assess the function and delivery reliability of intradermal (ID) infusion sets used with commercial insulin pumps.
METHOD
Healthy subjects (n = 43) were randomized to either ID or subcutaneous (SC) arms, and received basal/bolus placebo delivery for 24 hours. Subjects received 4 of 8 infusion set combinations (ID: microneedle design A or B, with 2 pump brands [Animas or MiniMed]; SC: Teflon Quickset or steel Rapid-D, Animas pump only, with or without overtaping) and were evaluated for pump occlusion alarms, fluid leakage, pain, and tissue tolerability. A novel algorithm was developed to determine flow consistency based on fluid pressure, and the duration and occurrence rate for periods of unalarmed but interrupted flow ("silent occlusions'") were compared.
RESULTS
ID delivery was successfully maintained over the 24-hour infusion period. The number of silent occlusions was lower for ID microneedle cannula design B than A (P < .01) and lower for Rapid-D SC device compared to Quick-set (P = .03). There was no significant difference in the number of occlusion alarms between the ID and SC devices with the Animas pump. However, the pumps tested with ID devices had significantly different alarm rates (MiniMed 29.5%, Animas 0%, P < .001). Leakage and tissue tolerability were comparable across devices.
CONCLUSION
The ID infusion set reliably delivered diluent for an extended 24-hour period in healthy subjects and was well tolerated. Silent occlusion flow interruptions could be detected in both ID and SC infusion sets using a proprietary algorithm. This algorithm is a promising method for quantitatively evaluating infusion set flow performance.
Topics: Adolescent; Adult; Algorithms; Clinical Alarms; Equipment Design; Equipment Failure; Feasibility Studies; Female; Healthy Volunteers; Humans; Hypoglycemic Agents; Infusions, Subcutaneous; Insulin; Insulin Infusion Systems; Male; Materials Testing; Middle Aged; Needles; Pressure; Time Factors; Young Adult
PubMed: 26319228
DOI: 10.1177/1932296815598327 -
Epilepsia Apr 2022To evaluate the pharmacokinetics, safety, and tolerability of brivaracetam (BRV) as 15-min intravenous (IV) infusion and bolus (≤2-min injection).
OBJECTIVE
To evaluate the pharmacokinetics, safety, and tolerability of brivaracetam (BRV) as 15-min intravenous (IV) infusion and bolus (≤2-min injection).
METHODS
EP0065 (ClinicalTrials.gov: NCT03405714) was a Phase 2, multicenter, open-label trial in patients ≥1 month to <16 years of age with epilepsy. Patients received up to 5 mg/kg/day BRV (not exceeding 200 mg/day). Enrollment was sequential by descending age, depending on safety review. Outcomes included BRV plasma concentrations before and after IV administration, treatment-emergent adverse events (TEAEs), and discontinuations due to TEAEs.
RESULTS
Fifty patients were enrolled, received BRV, and completed the trial. Twenty-six patients (52.0%) received 15-min infusions and 24 (48.0%) received bolus injections. Most patients (80.0%) received one IV dose. In the 15-min infusion group, geometric mean (GeoMean) BRV concentrations 15 (±2) min (n = 21) and 3 h (±15 min) (n = 21) post dose were 1903.0 ng/mL (geometric coefficient of variation [GeoCV]: 60.7%) and 1130.3 ng/mL (58.8%), respectively. In the bolus group, GeoMean BRV concentrations 15 (±2) min (n = 19) and 3 h (±15 min) (n = 21) post dose were 1704.8 ng/mL (GeoCV: 74.5%) and 1383.9 ng/mL (85.0%), respectively. Overall, 14 patients (28.0%) had TEAEs (15-min infusion: 8 [30.8%]; bolus: 6 [25.0%]), most commonly (≥5% of patients) somnolence (3 [6.0%]). Ten patients (20.0%) had drug-related TEAEs (15-min infusion: 6 [23.1%]; bolus: 4 [16.7%]). No patients discontinued due to TEAEs, and no deaths occurred.
SIGNIFICANCE
IV BRV (up to 200 mg/day) was well tolerated in patients ≥1 month to <16 years of age, regardless of whether BRV was administered as 15-min infusion or bolus. No unexpected safety or pharmacokinetic differences were observed between patients receiving 15-min infusions or bolus, and plasma concentrations were in the expected range. Safety results were consistent with the known safety profile of oral BRV, with no new safety concerns identified.
Topics: Anticonvulsants; Child; Double-Blind Method; Drug Therapy, Combination; Epilepsy; Humans; Pyrrolidinones; Treatment Outcome
PubMed: 35196395
DOI: 10.1111/epi.17187 -
The Cochrane Database of Systematic... Jul 2005Loop diuretics, when given as intermittent bolus injections in acutely decompensated heart failure, may cause fluctuations in intravascular volume, increased toxicity... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Loop diuretics, when given as intermittent bolus injections in acutely decompensated heart failure, may cause fluctuations in intravascular volume, increased toxicity and development of tolerance. Continuous infusion has been proposed to avoid these complications and result in greater diuresis, hopefully leading to faster symptom resolution, decrease in morbidity and possibly, mortality.
OBJECTIVES
To compare the effects and adverse effects of continuous intravenous infusion of loop diuretics with those of bolus intravenous administration among patients with congestive heart failure Class III-IV.
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2003), MEDLINE (1966 to 2003), EMBASE (1980 to 2003) and the HERDIN database. We also contacted pharmaceutical companies .
SELECTION CRITERIA
Randomized controlled trials comparing the efficacy of continuous intravenous infusion versus bolus intravenous administration of loop diuretics in congestive heart failure were included
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed study eligibility, methodological quality and did data extraction. Included studies were assessed for validity. Authors were contacted when feasible. Adverse effects information was collected from the trials.
MAIN RESULTS
Eight trials involving 254 patients were included. In seven studies which reported on urine output, the output (as measured in cc/24 hours) was noted to be greater in patients given continuous infusion with a weighted mean difference (WMD) of 271 cc/24 hour (95%CI 93.1 to 449; p<0.01). Electrolyte disturbances (hypokalemia, hypomagnesemia) were not significantly different in the two treatment groups with a relative risk (RR) of 1.47 (95%CI 0.52 to 4.15; p=0.5). Less adverse effects (tinnitus and hearing loss) were noted when continuous infusion was given, RR 0.06 (95%CI 0.01 to 0.44; p=0.005). Based on a single study, the duration of hospital stay was significantly shortened by 3.1days with continuous infusion WMD -3.1 (95%CI -4.06 to -2.20; p<0.0001) while cardiac mortality was significantly different in the two treatment groups, RR 0.47 (95% CI 0.33 to 0.69; p<0.0001). Based on two studies, all cause mortality was significantly different in the two treatment groups, RR 0.52 (95%CI 0.38 to 0.71; p<0.0001).
AUTHORS' CONCLUSIONS
Currently available data are insufficient to confidently assess the merits of the two methods of giving intravenous diuretics. Based on small and relatively heterogenous studies, this review showed greater diuresis and a better safety profile when loop diuretics were given as continuous infusion. The existing data still does not allow definitive recommendations for clinical practice and larger studies should be done to more adequately settle this issue.
Topics: Heart Failure; Humans; Infusions, Intravenous; Injections, Intravenous; Randomized Controlled Trials as Topic; Sodium Potassium Chloride Symporter Inhibitors
PubMed: 16034890
DOI: 10.1002/14651858.CD003178.pub3 -
BMJ (Clinical Research Ed.) Aug 2011To determine the effects of adding an oxytocin infusion to bolus oxytocin on blood loss at elective caesarean section. (Comparative Study)
Comparative Study Randomized Controlled Trial
OBJECTIVES
To determine the effects of adding an oxytocin infusion to bolus oxytocin on blood loss at elective caesarean section.
DESIGN
Double blind, placebo controlled, randomised trial, conducted from February 2008 to June 2010.
SETTING
Five maternity hospitals in the Republic of Ireland.
PARTICIPANTS
2069 women booked for elective caesarean section at term with a singleton pregnancy. We excluded women with placenta praevia, thrombocytopenia, coagulopathies, previous major obstetric haemorrhage (>1000 mL), or known fibroids; women receiving anticoagulant treatment; those who did not understand English; and those who were younger than 18 years.
INTERVENTION
Intervention group: intravenous slow 5 IU oxytocin bolus over 1 minute and additional 40 IU oxytocin infusion in 500 mL of 0.9% saline solution over 4 hours (bolus and infusion). Placebo group: 5 IU oxytocin bolus over 1 minute and 500 mL of 0.9% saline solution over 4 hours (placebo infusion) (bolus only). Main outcomes Major obstetric haemorrhage (blood loss >1000 mL) and need for an additional uterotonic agent.
RESULTS
We found no difference in the occurrence of major obstetric haemorrhage between the groups (bolus and infusion 15.7% (158/1007) v bolus only 16.0% (159/994), adjusted odds ratio 0.98, 95% confidence intervals 0.77 to 1.25, P=0.86). The need for an additional uterotonic agent in the bolus and infusion group was lower than that in the bolus only group (12.2% (126/1033) v 18.4% (189/1025), 0.61, 0.48 to 0.78, P<0.001). Women were less likely to have a major obstetric haemorrhage in the bolus and infusion group than in the bolus only group if the obstetrician was junior rather than senior (0.57, 0.35 to 0.92, P=0.02).
CONCLUSION
The addition of an oxytocin infusion after caesarean delivery reduces the need for additional uterotonic agents but does not affect the overall occurrence of major obstetric haemorrhage. Trial Registration Current Controlled Trials ISRCTN17813715.
Topics: Adult; Blood Loss, Surgical; Cesarean Section; Double-Blind Method; Drug Therapy, Combination; Elective Surgical Procedures; Female; Humans; Infusions, Intravenous; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Treatment Outcome
PubMed: 21807773
DOI: 10.1136/bmj.d4661 -
Medicina (Kaunas, Lithuania) Jan 2021The fixed-rate continuous background infusion mode with bolus dosing is a common modality for intravenous patient-controlled analgesia (PCA). However, some patients... (Randomized Controlled Trial)
Randomized Controlled Trial
The Optimizing Background Infusion Mode Decreases Intravenous Patient-Controlled Analgesic Volume and Opioid Consumption Compared to Fixed-Rate Background Infusion in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double-Blind Study.
The fixed-rate continuous background infusion mode with bolus dosing is a common modality for intravenous patient-controlled analgesia (PCA). However, some patients suffer from inadequate analgesia or opioid-related adverse effects due to the biphasic pattern of postoperative pain. Therefore, we investigated the postoperative analgesic efficacy of PCA using an optimizing background infusion mode (OBIM) where the background injection rate varies depending on the patient's bolus demand. We prospectively enrolled 204 patients who underwent laparoscopic cholecystectomy in a randomized, controlled, double-blind study. Patients were allocated to either the optimizing (group OBIM) or the traditional background infusion group (group TBIM). The numeric rating scale (NRS) score for pain was evaluated at admission to and discharge from the recovery room, as well as at the 6th, 24th, and 48th postoperative hours. Data on bolus demand count, total infused volume, and background infusion rate were downloaded from the PCA device at 30-min intervals until the 48th postoperative hour. The NRS score was not significantly different between groups throughout the postoperative period ( = 0.621), decreasing with time in both groups ( < 0.001). The bolus demand count was not significantly different between groups throughout ( = 0.756). The mean total cumulative infused PCA volume was lower in group OBIM (84.0 (95% confidence interval: 78.9-89.1) mL) than in group TBIM (102 (97.8-106.0) mL; < 0.001). The total cumulative opioid dose in fentanyl equivalents, after converting sufentanil to fentanyl using an equipotential dose ratio, was lower in group OBIM (714.1 (647.4-780.9) μg) than in group TBIM (963.7 (870.5-1056.9) μg); < 0.001). The background infusion rate was significantly different between groups throughout the study period ( < 0.001); it was higher in group OBIM than in group TBIM before the 12th postoperative hour and lower from the 18th to the 48th postoperative hour. The OBIM combined with bolus dosing reduces the cumulative PCA volume and opioid consumption compared to the TBIM combined with bolus dosing, while yielding comparable postoperative analgesia and bolus demand in patients undergoing laparoscopic cholecystectomy.
Topics: Analgesics; Analgesics, Opioid; Cholecystectomy, Laparoscopic; Double-Blind Method; Humans; Pain, Postoperative; Prospective Studies
PubMed: 33419086
DOI: 10.3390/medicina57010042 -
British Journal of Anaesthesia Oct 1992The mathematical development of the equations needed to determine the plasma concentrations of drug in a one-compartment pharmacokinetic model are developed from first...
The mathematical development of the equations needed to determine the plasma concentrations of drug in a one-compartment pharmacokinetic model are developed from first principles and are illustrated (with caution) by the use of morphine given by bolus or continuous i.v. injection or by a simulated i.m. injection. The equations allow the calculation of concentrations, given a knowledge of what drug is currently present, what are the sizes of the boluses by either i.m. or i.v. injection and what is the constant infusion rate. What happens when changes occur is also illustrated. The development illustrates the principles needed to apply to more complex models.
Topics: Humans; Infusions, Intravenous; Injections, Intravenous; Mathematics; Models, Biological; Morphine; Pain, Postoperative; Pharmacokinetics
PubMed: 1419448
DOI: 10.1093/bja/69.4.387 -
PeerJ 2017Because etomidate induces prolonged adrenal suppression, even following a single bolus, its use as an infused anesthetic is limited. Our previous study indicated that a...
BACKGROUND
Because etomidate induces prolonged adrenal suppression, even following a single bolus, its use as an infused anesthetic is limited. Our previous study indicated that a single administration of the novel etomidate analog methoxyethyletomidate hydrochloride (ET-26-HCl) shows little suppression of adrenocortical function. The aims of the present study were to (1) determine the minimum infusion rate of ET-26-HCl and compare it with those for etomidate and cyclopropyl-methoxycarbonylmetomidate (CPMM), a rapidly metabolized etomidate analog that is currently in clinical trials and (2) to evaluate adrenocortical function after a continuous infusion of ET-26-HCl as part of a broader study investigating whether this etomidate analog is suitable for long infusion in the maintenance of anesthesia.
METHOD
The up-and-down method was used to determine the minimum infusion rates for ET-26-HCl, etomidate and CPMM. Sprague-Dawley rats ( = 32) were then randomly divided into four groups: etomidate, ET-26-HCl, CPMM, and vehicle control. Rats in each group were infused for 60 min with one of the drugs at its predetermined minimum infusion rate. Blood samples were drawn initially and then every 30 min after drug infusion to determine the adrenocorticotropic hormone-stimulated concentration of serum corticosterone as a measure of adrenocortical function.
RESULTS
The minimum infusion rates for etomidate, ET-26-HCl and CPMM were 0.29, 0.62, and 0.95 mg/kg/min, respectively. Compared with controls, etomidate decreased serum corticosterone, as expected, whereas serum corticosterone concentrations following infusion with the etomidate analogs ET-26-HCl or CPMM were not significantly different from those in the control group.
CONCLUSION
The corticosterone concentrations tended to be reduced for the first hour following ET-26-HCl infusion (as compared to vehicle infusion); however, this reduction did not reach statistical significance. Thus, further studies are warranted examining the practicability of using ET-26-HCl as an infused anesthetic.
PubMed: 28890850
DOI: 10.7717/peerj.3693 -
Nutrition in Clinical Practice :... Jun 2010Cyclic (discontinuous) infusion of parenteral nutrition (PN) presents a clear practical advantage over continuous 24-hour infusion in patients receiving long-term or... (Review)
Review
BACKGROUND
Cyclic (discontinuous) infusion of parenteral nutrition (PN) presents a clear practical advantage over continuous 24-hour infusion in patients receiving long-term or home PN. It is important for nutrition support clinicians to recognize the metabolic consequences of cyclic infusion.
METHODS
A literature search was conducted through PubMed (1948 to December 2009) and MEDLINE (1950 to November 2009) using the search term parenteral nutrition plus any of the following: cycling, cycle, cyclic, discontinuous, intermittent, bolus. Prospective clinical studies characterizing the metabolic effects of cyclic PN infusion in humans and their references were reviewed.
RESULTS
Twenty-five studies met inclusion criteria and were included in the review. Sample sizes were 4-65 (18 studies examined < or =20 patients, 9 examined < or =10 patients). Eight studies had important design elements that limit interpretability. Cyclic and continuous PN infusions result in similar nitrogen balance and circulating counterregulatory hormone concentrations. Following PN infusion, carbohydrate oxidation decreases, fat oxidation increases, and the respiratory quotient decreases. In acutely ill mechanically ventilated patients, carbon dioxide production increases. Cyclic infusion may stabilize liver function tests in some patients with mild hyperbilirubinemia (< or =20 ng/mL) on continuous PN infusion. Abrupt infusion initiation may cause hyperglycemia. Abrupt discontinuation may cause hypoglycemia, predominantly in children younger than 2-3 years old, which may decrease with infusion tapering. Cyclic PN infusion is not associated with increased daily calcium, phosphorus, magnesium, or vitamin D losses.
CONCLUSIONS
These results indicate a favorable risk-benefit profile of cyclic PN infusion in most patients receiving long-term or home PN, in support of current practices.
Topics: Adult; Carbon Dioxide; Child; Critical Care; Dietary Carbohydrates; Dietary Fats; Hormones; Humans; Hyperbilirubinemia; Hyperglycemia; Hypoglycemia; Infusions, Parenteral; Metabolism; Nitrogen; Parenteral Nutrition; Respiration, Artificial
PubMed: 20581322
DOI: 10.1177/0884533610368701 -
Metabolism: Clinical and Experimental Dec 2014The use of stable isotope tracer techniques to measure muscle protein fractional synthesis rate (FSR) has been well established and widely used. The most common method... (Comparative Study)
Comparative Study
BACKGROUND
The use of stable isotope tracer techniques to measure muscle protein fractional synthesis rate (FSR) has been well established and widely used. The most common method that has been utilized so far is a primed constant infusion (CI) method, which requires 3-4 h of tracer infusion. However, recently our group has developed a bolus injection (BI) method, which requires an injection of bolus of tracer and can be completed within 1 h. In this study, we compared calf (gastrocnemius) muscle protein FSR measured using these two different methods--CI and BI.
METHOD
FSRs were measured in eight people (5 men and 3 women; age: 62.3±6.9 years (mean±SD); body weight: 75.4±21.5 kg) at basal, postabsorptive state using L-[ring-2H5]-phenylalanine. In the CI protocol, a primed continuous infusion was given for 4 h, and muscle biopsies were taken at 120 and 240 min; in the BI, a bolus injection of the tracer was given at 0 min and biopsies were taken at 5 and 60 min. Tracer enrichments in blood and muscle tissue were determined by gas chromatography-mass spectrometry. Data are expressed as mean±SE; t-test, linear regression and Levene Median equal variance test analyses were performed.
RESULTS
CI FSR was 0.066±0.006%/h, whereas BI FSR was 0.058±0.008%/h, p=NS. The linear regression analysis showed a significant relationship between BI and CI, p=0.038. The intra-class correlation coefficient was 0.83. The standard deviation of the differences in the measurements was 0.015%/h. The Levene Median equal variance test demonstrated no difference in variance between the CI and BI measurements (p=0.722).
CONCLUSION
No difference could be detected in calf muscle protein FSR measured by CI and BI methods; the BI method can be used for the measurement of muscle protein FSR in humans.
Topics: Aged; Deuterium; Female; Humans; Infusions, Intravenous; Injections, Intravenous; Male; Middle Aged; Muscle Proteins; Phenylalanine; Radiopharmaceuticals
PubMed: 25308445
DOI: 10.1016/j.metabol.2014.09.009 -
Journal of Anesthesia Feb 2022To investigate the efficacy and safety of low-dose bolus plus continuous infusion of penehyclidine in preventing postoperative nausea and vomiting (PONV) following... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
To investigate the efficacy and safety of low-dose bolus plus continuous infusion of penehyclidine in preventing postoperative nausea and vomiting (PONV) following bimaxillary surgery.
METHODS
Three hundred fifty-four patients were randomly allocated into three groups. In the Control group, placebo (normal saline) was injected before anesthesia and infused over 48 h after surgery; in the Bolus group, 0.5 mg penehyclidine was injected before anesthesia, whereas placebo was infused after surgery; in the Infusion group, 0.25 mg penehyclidine were injected before anesthesia, another 0.25 mg penehyclidine was infused after surgery. The primary endpoint was the incidence of PONV within 72 h.
RESULTS
A total of 353 patients were included in intention-to-treat analysis. The PONV incidence was 61.0% (72/118) in the Control group, 40.2% (47/117) in the Bolus group, and 28.0% (33/118) in the Infusion group. The incidence was significantly lower in the Bolus group than in the Control group (RR 0.66; 95% CI 0.51-0.86; adjusted P = 0.003) and in the Infusion group than in the Control group (RR 0.46; 95% CI 0.33-0.63; adjusted P < 0.001); the difference between the Infusion and Bolus groups was not statistically significant (RR 0.70; 95% CI 0.48-1.00; adjusted P = 0.144). Emergence agitation occurred more frequently in the Bolus group than in the Control group (36.8% [43/117] vs. 21.2% [25/118], adjusted P = 0.027), but did not differ significantly between the Infusion and Control groups.
CONCLUSIONS
A low-dose bolus plus continuous infusion of penehyclidine was effective in preventing PONV without increasing emergence agitation.
TRIAL REGISTRATION
Clinicaltrials.gov. Identifier: NCT04454866.
Topics: Antiemetics; Double-Blind Method; Humans; Orthognathic Surgery; Postoperative Nausea and Vomiting; Quinuclidines
PubMed: 34738161
DOI: 10.1007/s00540-021-03017-4