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Journal of Medical Case Reports Jun 2024Urinothorax and urinoma are rare complications of obstructive uropathy. They might occur due to persistent high back pressure on the renal parenchyma. Urinothorax...
Right perirenal urinoma and urinothorax in an infant after neonatal ablation of posterior urethral valve: A rare complication diagnosed by pleural aspiration and treated with perinephric drainage: a case report.
OBJECTIVE
Urinothorax and urinoma are rare complications of obstructive uropathy. They might occur due to persistent high back pressure on the renal parenchyma. Urinothorax usually arises while the obstruction exists; in contrast to our case, the child presented after being operated on. He had falsely high creatinine before the operation, which was later explained by creatinine recirculation.
CLINICAL PRESENTATION AND INTERVENTION
We are reporting an uncommon case of late presentation of ruptured urinoma in a 2-month-old Kuwaiti male. It led to urinothorax/uroperitoneum that caused respiratory distress and was associated with creatinine recirculation, requiring retroperitoneal perinephric catheter insertion. The child had recovered and was discharged home.
CONCLUSION
A high index of suspicion is required to diagnose urinothorax, especially in patients with a history of obstructive uropathy. Aspiration of the pleural effusion will guide you to reach the diagnosis. Creatinine recirculation is rarely described in the literature. Having a patient with urinothorax/uroperitoneum should raise the suspicion of falsely elevated creatinine levels.
Topics: Humans; Urinoma; Male; Infant; Drainage; Pleural Effusion; Creatinine; Urethra; Treatment Outcome; Urethral Obstruction
PubMed: 38943217
DOI: 10.1186/s13256-024-04634-9 -
Parasites & Vectors Jun 2024Reliance on praziquantel for the treatment and control of schistosomiasis is likely to facilitate the emergence of drug resistance. Combination therapy targeting adult... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy and safety of single-dose artesunate plus sulfalene/pyrimethamine combined with praziquantel for the treatment of children with Schistosoma mansoni or Schistosoma haematobium in western Kenya: a randomised, open-label controlled trial.
BACKGROUND
Reliance on praziquantel for the treatment and control of schistosomiasis is likely to facilitate the emergence of drug resistance. Combination therapy targeting adult and juvenile schistosome worms is urgently needed to improve praziquantel efficacy and delay the potential development of drug resistance. We assessed the efficacy and safety of single-dose praziquantel combined with single-dose artesunate plus sulfalene-pyrimethamine in the treatment of Kenyan children with schistosomiasis.
METHODS
This was an open-label, randomised clinical trial involving 426 school-aged children (7-15 years old) diagnosed with Schistosoma mansoni (by Kato-Katz) or S. haematobium (by urine filtration). They were randomly assigned (1:1:1) to receive a single dose of praziquantel (40 mg/kg), a single dose of artesunate plus sulfalene-pyrimethamine (12 mg/kg artesunate) or combination therapy using a single dose of praziquantel (40 mg/kg) combined with a single dose of artesunate plus sulfalene-pyrimethamine (12 mg/kg artesunate). The primary outcome was cure and egg reduction rates at 6 weeks post-treatment in the available case population. Adverse events were assessed within 3 h after treatment.
RESULTS
Of the 426 children enrolled, 135 received praziquantel, 150 received artesunate plus sulfalene-pyrimethamine, and 141 received combination therapy. Outcome data were available for 348 (81.7%) children. For S. mansoni-infected children (n = 335), the cure rates were 75.6%, 60.7%, and 77.8%, and the egg reduction rates were 80.1%, 85.0%, and 88.4% for praziquantel, artesunate plus sulfalene-pyrimethamine, and combination therapy, respectively. For S. haematobium-infected children (n = 145), the corresponding cure rates were 81.4%, 71.1%, and 82.2%, and the egg reduction rates were 95.6%, 97.1%, and 97.7%, respectively. Seventy-one (16.7%) children reported mild-intensity adverse events. The drugs were well tolerated and no serious adverse events were reported.
CONCLUSIONS
A single oral dose of praziquantel combined with artesunate plus sulfalene-pyrimethamine cured a high proportion of children with S. haematobium but did not significantly improve the treatment efficacy for either urinary or intestinal schistosomiasis. Sequential administration of praziquantel and artesunate plus sulfalene-pyrimethamine may enhance the efficacy and safety outcomes.
Topics: Humans; Child; Praziquantel; Pyrimethamine; Animals; Adolescent; Artesunate; Female; Male; Schistosomiasis mansoni; Schistosoma haematobium; Schistosomiasis haematobia; Schistosoma mansoni; Drug Therapy, Combination; Kenya; Artemisinins; Treatment Outcome; Anthelmintics; Sulfalene; Drug Combinations; Parasite Egg Count
PubMed: 38943214
DOI: 10.1186/s13071-024-06359-6 -
Journal of Medical Case Reports Jun 2024Colon volvulus is the twisting of a segment of colon on its mesenteric axis, which can lead to the obstruction of the lumen and the blood supply. Colon volvulus is...
INTRODUCTION
Colon volvulus is the twisting of a segment of colon on its mesenteric axis, which can lead to the obstruction of the lumen and the blood supply. Colon volvulus is common in "volvulus belt" countries and can involve the sigmoid (60-70%) and cecum (25-40%).
CASE PRESENTATION
We report a case of a 47-year-old male, Alawites, who presented with bowel obstruction and dilated abdomen without any specific abdominal pain. Abdominal laparotomy showed both sigmoid and cecum volvulus with no signs of perforation or ischemia.
DISCUSSION AND CONCLUSION
One of the possible risk factors of sigmoid colon volvulus is the length of the rectum and sigmoid, while mobile cecum is considered as a possible reason for cecum volvulus. The management remains controversial and is specific for every case, depending mainly on the vitality of the colonic walls and the general condition of the patient.
Topics: Humans; Intestinal Volvulus; Male; Middle Aged; Colon, Sigmoid; Cecal Diseases; Sigmoid Diseases; Intestinal Obstruction; Cecum; Laparotomy; Treatment Outcome
PubMed: 38943209
DOI: 10.1186/s13256-024-04622-z -
Trials Jun 2024Most patients starting chronic in-center hemodialysis (HD) receive conventional hemodialysis (CHD) with three sessions per week targeting specific biochemical clearance....
Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial).
BACKGROUND
Most patients starting chronic in-center hemodialysis (HD) receive conventional hemodialysis (CHD) with three sessions per week targeting specific biochemical clearance. Observational studies suggest that patients with residual kidney function can safely be treated with incremental prescriptions of HD, starting with less frequent sessions and later adjusting to thrice-weekly HD. This trial aims to show objectively that clinically matched incremental HD (CMIHD) is non-inferior to CHD in eligible patients.
METHODS
An unblinded, parallel-group, randomized controlled trial will be conducted across diverse healthcare systems and dialysis organizations in the USA. Adult patients initiating chronic hemodialysis (HD) at participating centers will be screened. Eligibility criteria include receipt of fewer than 18 treatments of HD and residual kidney function defined as kidney urea clearance ≥3.5 mL/min/1.73 m and urine output ≥500 mL/24 h. The 1:1 randomization, stratified by site and dialysis vascular access type, assigns patients to either CMIHD (intervention group) or CHD (control group). The CMIHD group will be treated with twice-weekly HD and adjuvant pharmacologic therapy (i.e., oral loop diuretics, sodium bicarbonate, and potassium binders). The CHD group will receive thrice-weekly HD according to usual care. Throughout the study, patients undergo timed urine collection and fill out questionnaires. CMIHD will progress to thrice-weekly HD based on clinical manifestations or changes in residual kidney function. Caregivers of enrolled patients are invited to complete semi-annual questionnaires. The primary outcome is a composite of patients' all-cause death, hospitalizations, or emergency department visits at 2 years. Secondary outcomes include patient- and caregiver-reported outcomes. We aim to enroll 350 patients, which provides ≥85% power to detect an incidence rate ratio (IRR) of 0.9 between CMIHD and CHD with an IRR non-inferiority of 1.20 (α = 0.025, one-tailed test, 20% dropout rate, average of 2.06 years of HD per patient participant), and 150 caregiver participants (of enrolled patients).
DISCUSSION
Our proposal challenges the status quo of HD care delivery. Our overarching hypothesis posits that CMIHD is non-inferior to CHD. If successful, the results will positively impact one of the highest-burdened patient populations and their caregivers.
TRIAL REGISTRATION
Clinicaltrials.gov NCT05828823. Registered on 25 April 2023.
Topics: Humans; Renal Dialysis; Multicenter Studies as Topic; Treatment Outcome; Time Factors; Comparative Effectiveness Research; Randomized Controlled Trials as Topic; Equivalence Trials as Topic; United States; Kidney Failure, Chronic
PubMed: 38943204
DOI: 10.1186/s13063-024-08281-9 -
Trials Jun 2024Acute leukaemias (AL) are life-threatening blood cancers that can be potentially cured with treatment involving myelosuppressive, multiagent, intensive chemotherapy...
Biomarker Driven Antifungal Stewardship (BioDriveAFS) in acute leukaemia-a multi-centre randomised controlled trial to assess clinical and cost effectiveness: a study protocol for a randomised controlled trial.
BACKGROUND
Acute leukaemias (AL) are life-threatening blood cancers that can be potentially cured with treatment involving myelosuppressive, multiagent, intensive chemotherapy (IC). However, such treatment is associated with a risk of serious infection, in particular invasive fungal infection (IFI) associated with prolonged neutropenia. Current practice guidelines recommend primary antifungal (AF) prophylaxis to be administered to high-risk patients to reduce IFI incidence. AFs are also used empirically to manage prolonged neutropenic fever. Current strategies lead to substantial overuse of AFs. Galactomannan (GM) and β-D-glucan (BG) biomarkers are also used to diagnose IFI. Combining both biomarkers may enhance the predictability of IFI compared to administering each test alone. Currently, no large-scale randomised controlled trial (RCT) has directly compared a biomarker-based diagnostic screening strategy without AF prophylaxis to AF prophylaxis (without systematic biomarker testing).
METHODS
BioDriveAFS is a multicentre, parallel, two-arm RCT of 404 participants from UK NHS Haematology departments. Participants will be allocated on a 1:1 basis to receive either a biomarker-based antifungal stewardship (AFS) strategy, or a prophylactic AF strategy, which includes existing standard of care (SoC). The co-primary outcomes will be AF exposure in the 12-month post randomisation and the patient-reported EQ-5D-5L measured at 12-month post randomisation. Secondary outcomes will include total AF exposure, probable/proven IFI, survival (all-cause mortality and IFI mortality), IFI treatment outcome, AF-associated adverse effects/events/complications, resource use, episodes of neutropenic fever requiring hospital admission or outpatient management, AF resistance in fungi (non-invasive and invasive) and a Desirability of Outcome Ranking. The trial will have an internal pilot phase during the first 9 months. A mixed methods process evaluation will be integrated in parallel to the internal pilot phase and full trial, aiming to robustly assess how the intervention is delivered. Cost-effectiveness analysis will also be performed.
DISCUSSION
The BioDriveAFS trial aims to further the knowledge of strategies that will safely optimise AF use through comparison of the clinical and cost-effectiveness of a biomarker-led diagnostic strategy versus prophylactic AF to prevent and manage IFI within acute leukaemia. The evidence generated from the study will help inform global clinical practice and approaches within antifungal stewardship.
TRIAL REGISTRATION
ISRCTN11633399. Registered 24/06/2022.
Topics: Humans; Antifungal Agents; Cost-Benefit Analysis; Randomized Controlled Trials as Topic; Invasive Fungal Infections; Multicenter Studies as Topic; Biomarkers; Galactose; Mannans; Treatment Outcome; beta-Glucans; Antimicrobial Stewardship; Leukemia; Time Factors; Cost-Effectiveness Analysis
PubMed: 38943201
DOI: 10.1186/s13063-024-08272-w -
Critical Care (London, England) Jun 2024In a phase 3 trial (PANAMO, NCT04333420), vilobelimab, a complement 5a (C5a) inhibitor, reduced 28-day mortality in mechanically ventilated COVID-19 patients. This post... (Randomized Controlled Trial)
Randomized Controlled Trial
In a phase 3 trial (PANAMO, NCT04333420), vilobelimab, a complement 5a (C5a) inhibitor, reduced 28-day mortality in mechanically ventilated COVID-19 patients. This post hoc analysis of 368 patients aimed to explore treatment heterogeneity through unsupervised learning. All available clinical variables at baseline were used as input. Treatment heterogeneity was assessed using latent class analysis (LCA), Ward's hierarchical clustering (HC) and the adjudication to previously described clinical sepsis phenotypes. The primary outcome was 28-day mortality. For LCA, a 2-class latent model was deemed most suitable. In the LCA model, 82 (22%) patients were assigned to class 1 and 286 (78%) to class 2. Class 1 was defined by more severely ill patients with significantly higher mortality. In an adjusted logistic regression, no heterogeneity of treatment effect (HTE) between classes was observed (p = 0.998). For HC, no significant classes were found (p = 0.669). Using the previously described clinical sepsis subtypes, 41 patients (11%) were adjudicated subtype alpha (α), 17 (5%) beta (β), 112 (30%) delta (δ) and 198 (54%) gamma (γ). HTE was observed between clinical subtypes (p = 0.001) with improved 28-day mortality after treatment with vilobelimab for the δ subtype (OR = 0.17, 95% CI 0.07-0.40, p < 0.001). No signal for harm of treatment with vilobelimab was observed in any class or clinical subtype. Overall, treatment effect with vilobelimab was consistent across different classes and subtypes, except for the δ subtype, suggesting potential additional benefit for the most severely ill patients.
Topics: Humans; Female; Male; Middle Aged; Aged; COVID-19 Drug Treatment; Antibodies, Monoclonal, Humanized; Treatment Outcome; COVID-19
PubMed: 38943192
DOI: 10.1186/s13054-024-05004-z -
Trials Jun 2024Isolated REM sleep behavior disorder (iRBD) is an early α-synucleinopathy often accompanied by incipient cognitive impairment. As executive dysfunctions predict earlier...
Cognitive training and promoting a healthy lifestyle for individuals with isolated REM sleep behavior disorder: study protocol of the delayed-start randomized controlled trial CogTrAiL-RBD.
BACKGROUND
Isolated REM sleep behavior disorder (iRBD) is an early α-synucleinopathy often accompanied by incipient cognitive impairment. As executive dysfunctions predict earlier phenotypic conversion from iRBD to Parkinson's disease and Lewy body dementia, cognitive training focusing on executive functions could have disease-modifying effects for individuals with iRBD.
METHODS
The study CogTrAiL-RBD investigates the short- and long-term effectiveness and the feasibility and underlying neural mechanisms of a cognitive training intervention for individuals with iRBD. The intervention consists of a 5-week digital cognitive training accompanied by a module promoting a healthy, active lifestyle. In this monocentric, single-blinded, delayed-start randomized controlled trial, the intervention's effectiveness will be evaluated compared to an initially passive control group that receives the intervention in the second, open-label phase of the study. Eighty individuals with iRBD confirmed by polysomnography will be consecutively recruited from the continuously expanding iRBD cohort at the University Hospital Cologne. The evaluation will focus on cognition and additional neuropsychological and motor variables. Furthermore, the study will examine the feasibility of the intervention, effects on physical activity assessed by accelerometry, and interrogate the intervention's neural effects using magnetic resonance imaging and polysomnography. Besides, a healthy, age-matched control group (HC) will be examined at the first assessment time point, enabling a cross-sectional comparison between individuals with iRBD and HC.
DISCUSSION
This study will provide insights into whether cognitive training and psychoeducation on a healthy, active lifestyle have short- and long-term (neuro-)protective effects for individuals with iRBD.
TRIAL REGISTRATION
The study was prospectively registered in the German Clinical Trial Register (DRKS00024898) on 2022-03-11, https://drks.de/search/de/trial/DRKS00024898 .
PROTOCOL VERSION
V5 2023-04-24.
Topics: Humans; Single-Blind Method; REM Sleep Behavior Disorder; Healthy Lifestyle; Randomized Controlled Trials as Topic; Executive Function; Cognition; Time Factors; Polysomnography; Treatment Outcome; Cognitive Behavioral Therapy; Male; Germany; Middle Aged; Exercise; Female; Aged; Feasibility Studies; Cognitive Training
PubMed: 38943191
DOI: 10.1186/s13063-024-08265-9 -
Nutrition & Metabolism Jun 2024Conflicting findings regarding the impact of High protein intake during the early phase in critically ill patients have been reported. Therefore, we aimed to assess the...
BACKGROUND
Conflicting findings regarding the impact of High protein intake during the early phase in critically ill patients have been reported. Therefore, we aimed to assess the influence of higher early protein intake on the prognosis of critically ill patients.
METHODS
This randomized controlled trial involved 173 critically ill patients who stayed in the Intensive Care Unit/Emergency ICU (ICU/EICU) for at least 7 days. The Low group (n = 87) and High group (n = 86) received protein supplementation of 0.8 g/kg.d and 1.5 g/kg.d, respectively, within 1-3 days of enteral nutrition (EN) initiation, with both groups transitioning to 1.5 g/kg.d on the 4th day. The serum prealbumin (PA), blood urea nitrogen/creatinine, and rectus femoris muscle thickness and cross-sectional area of all patients was measured on the 1th, 3rd, 5th, 7th day, and the day of ICU/EICU discharge.
RESULTS
Patients in both Low and High groups showed no significant differences in age, APACHE II scores, or other demographic and baseline characteristics. There were also no significant differences in the primary outcome (28-day mortality rate) and secondary outcomes (incidence rate of refeeding syndrome and EN tolerance score) between the two groups. However, the Low group exhibited a significantly higher 28-day mortality rate (HR = 2.462, 95% CI: 1.021-5.936, P = 0.045) compared to High group, as determined by Cox proportional hazards models incorporating the time factor. The High group exhibited significantly shorter durations of mechanical ventilation and ICU stay compared to the Low group. Serum PA levels were higher, and rectus femoris muscle atrophy rates were lower in the High group. Furthermore, for septic patients, high protein intake significantly reduced the 28-day mortality rate despite a small sample size (n = 34).
CONCLUSIONS
Our study indicates that increasing early protein intake to 1.5 g/kg.d may be safe and help improve the nutritional status and prognosis of critically ill patients.
TRIAL REGISTRATION
This study was registered with the Chinese Clinical Trial Registry (ChiCTR2000039997, https://www.chictr.org.cn/ ).
PubMed: 38943189
DOI: 10.1186/s12986-024-00818-8 -
International Journal For Equity in... Jun 2024Neighbourhood effect on health outcomes is well established, but little is known about its effect on access to essential health services (EHS). Therefore, this study...
Neighbourhood effect and inequality in access to essential health services among mother-child paired samples: a decomposition analysis of data from 58 low- and middle-income countries.
INTRODUCTION
Neighbourhood effect on health outcomes is well established, but little is known about its effect on access to essential health services (EHS). Therefore, this study aimed to assess the contributing factors to access to EHS in slum versus non-slum settings.
METHODOLOGY
The most recent data from 58 Demographic and Health Surveys (DHS) conducted between 2011 and 2018 were used, including a total of 157,000 pairs of currently married women aged 15-49 and their children aged 12-23 months. We used meta-analysis techniques to examine the inequality gaps in suboptimal access to EHS between mother-children pairs living in slums and non-slums. Blinder-Oaxaca decomposition technique was used to identify the factors contributing to the inequality gaps in each low- and middle-income country (LMIC) included.
RESULT
The percentage of mother-child pairs living in slums ranged from 0.5% in Egypt to 63.7% in Congo. Meta-analysis of proportions for the pooled sample revealed that 31.2% [27.1, 35.5] of slum residents and 20.0% [15.3, 25.2] among non-slum residents had suboptimal access to EHS. We observed significant pro-slum inequalities in suboptimal access to EHS in 28 of the 52 LMICs with sufficient data. Of the 34 African countries included, 16 showed statistically significant pro-slum inequality in suboptimal access to EHS, with the highest in Egypt and Mali (2.64 [0.84-4.44] and 1.76 [1.65, 1.87] respectively). Findings from the decomposition analysis showed that, on average, household wealth, neighbourhood education level, access to media, and neighbourhood-level illiteracy contributed mostly to slum & non-slum inequality gaps in suboptimal access to EHS.
CONCLUSION
The study showed evidence of inequality in access to EHS due to neighbourhood effects in 26 LMICs. This evidence suggests that increased focus on the urban poor might be a important for increasing access to EHS and achieving the universal health coverage (UHC) goals.
Topics: Humans; Health Services Accessibility; Female; Adolescent; Adult; Residence Characteristics; Developing Countries; Infant; Young Adult; Middle Aged; Poverty Areas; Healthcare Disparities; Socioeconomic Factors; Male; Mothers
PubMed: 38943187
DOI: 10.1186/s12939-024-02194-4 -
Trials Jun 2024Vitamin D is necessary to develop healthy lungs and other organs early in life. Most infants born before 28 weeks' gestation have low vitamin D levels at birth and a...
BACKGROUND
Vitamin D is necessary to develop healthy lungs and other organs early in life. Most infants born before 28 weeks' gestation have low vitamin D levels at birth and a limited intake during the first month. Enteral vitamin D supplementation is inexpensive and widely used. The appropriate supplementation regimen for extremely preterm infants is controversial, and the effect of different regimens on their blood levels and outcomes is unclear.
METHODS
Randomized, blinded comparative effectiveness trial to compare two vitamin D supplementation regimens for inborn infants <28 weeks gestation or <1000 g birth weight at a large academic center in the United States. Infants are stratified by birth weight and randomized within 96 h after birth to either routine supplementation (400 IU/day with established feedings) or increased supplementation (800 IU/day with any feedings) during the first 28 days after birth. We hypothesize that the higher and early vitamin D dose (800 IU/day with early feeding) compared to placebo plus routine dose (400 IU/day with established feeding) will substantially increase total 25-hydroxyvitamin D3 levels measured as state-of-art at 1 month, reduce respiratory support at 36 weeks' postmenstrual age (on an ordinal scale predictive of later adverse outcomes), and improve or at least not worsen other important secondary outcomes. The infants in the study will follow up at 22-26 months' corrected age (~2 years) with blinded certified examiners to evaluate neurodevelopmental outcomes. The sample size of a minimum of 180 infants provides >90% power to detect a >95% posterior probability of a 33% increase in serum 25-hydroxy vitamin D3 and >80% power to detect a >80% posterior probability of a relative risk decrease of 20% of reducing respiratory support by intention-to-treat Bayesian analyses using a neutral prior probability.
DISCUSSION
Our study will help clarify the uncertain relationship of vitamin D supplementation and its associated serum metabolites to clinical outcomes of extremely preterm infants. Confirmation of our hypotheses would prompt reconsideration of the supplementation regimens used in extremely preterm infants and justify a large multicenter study to verify the generalizability of the results.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05459298. Registered on July 14, 2022.
Topics: Humans; Infant, Newborn; Gestational Age; Dietary Supplements; Randomized Controlled Trials as Topic; Vitamin D; Birth Weight; Enteral Nutrition; Vitamin D Deficiency; Treatment Outcome; Infant, Extremely Premature; Time Factors; Female; Vitamins; Calcifediol; Male
PubMed: 38943179
DOI: 10.1186/s13063-024-08274-8