Phase 4 N=23 GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study
Pediatric Sepsis-induced MODS
Primary: Number of Subjects With Restoration of the TNF-alpha Response — 10; 8 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=185 Algorithm for Predicting the Unfavorable Course of Sepsis in Children
Sepsis
Primary: Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes — 16.0; 11.2; 11.9; 4.9 10^9 cells/l — p=<0.05
N/A N=18,693 Paediatric Rapid Sepsis Trigger (PRST) Tool
Sepsis · Infection
Primary: Time to Administration of an Appropriate Antimicrobial — 115; 123; 239; 261 minutes
N/A N=271 Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit
Sepsis · Procalcitonin · Antimicrobial Stewardship
Primary: Days of Antibiotic Therapy in the First 14 Days Following Randomization — 7.6; 6.6 days
N/A N=28 Sepsis-Associated Purpura Fulminans International Registry - Europe
Sepsis
Primary: Mortality — 11 Participants
N/A N=513 Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome
Primary: 28 Day Mortality in Pediatric ARDS. — 44 Participants — p=<0.05
Phase 2 N=12 Pharmacokinetic and Biomarker Study of Pioglitazone in Adolescents With Severe Sepsis and Septic Shock
Severe Sepsis · Septic Shock
Primary: Evaluate the Safety Profile of Pioglitazone in Patients With Severe Sepsis and Septic Shock as the Number of Hypoglycemic Events — 0; 0 events — p=1.0
Phase 4 N=57 Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study
Shock
Primary: Patient Accrual Rate Over One Year (% of Target Sample Size Achieved) — 82 percentage of target sample size
N/A N=144 Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis
Sepsis · Necrotising Enterocolitis Neonatal
Primary: Number of Participants With Sepsis or Necrotizing Enterocolitis — 20; 124 Participants
N/A N=22 Piperacillin PK Analysis in Severe Sepsis Patients
Sepsis · Severe Sepsis
Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 4 participants
N/A N=106,629 Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
Sepsis
Primary: Door-to-antibiotic Time — 160; 146; 139; 140 minutes — p=<0.001
N/A N=121 Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
Sepsis
Primary: Antibiotic Treatment for More Than 72 Hours — 33; 55 participants — p=0.002
N/A N=40 Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study
Congenital Heart Disease · Inflammation
Primary: Inflammatory Mediator C3a — 30 pg/ml
N/A N=73 Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS
Sepsis
Primary: Delta Curve Between Calculated GFR and GFR Measured by Iohexol at Baseline — 91.5; 88.3; 93.6; 90.0 ml/min/1.73m2 — p=<0.05
N/A N=21 Inflammatory Cytokine Quantification in Infants
Sepsis · Congenital Diaphragmatic Hernia · Neonatal Cardiopulmonary Failure
Primary: TNF-alpha, Baseline — 8.88 pg/mL
N/A N=426 Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
Sepsis
Primary: Number of Participants With Clinical Response — 178; 169 Participants — p=0.156
N/A N=142 Preemptive Resuscitation for Eradication of Septic Shock
Sepsis · Severe Sepsis
Primary: Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1 — 34; 20 Participants — p=0.064
N/A N=245 Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
Acute Kidney Injury · Hypoxia-Ischemia, Brain · Mesenteric Ischemia
Primary: Number of Participants With Acute Kidney Injury — 18; 57 Participants
N/A N=120 Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Community Acquired Pneumonia
Pneumonia
Primary: Use of Antibiotics in Each Group — 28; 52 participants
Phase 3 N=30 Cholecalciferol Supplementation for Sepsis in the ICU
Hypovitaminosis D
Primary: Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol — 19; 15; 17; 19 ng/mL
Phase 2 N=167 Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury
Acute Lung Injury · Sepsis
Primary: Modified Change in Sequential Organ Failure Assessment (mSOFA) Score — -2.96; -3.20 score on a scale
Phase 1 N=50 Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study
Shock, Septic
Primary: Compliance With Study Fluid Administration in the Assigned Study Arm — 0; 100 Proportion of total crystalloids adminis
N/A N=15 PK Analysis of Piperacillin in Septic Shock Patients
Septic Shock
Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 10 participants
Phase 2 N=488 Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery
Acute Respiratory Distress Syndrome · Critical Illness · Respiratory Failure
Primary: Days Alive and Free of Organ Support to Day 28 — 20.2; 20.5; 19.7; 18.4 days — p=0.65
N/A N=188 Implementing a Combination of Clinical Parameters, Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients
Pneumonia
Primary: White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens — 12.2; 6.15 10^3 cells/microliter — p=0.0048
N/A N=450 Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
Septic Shock · Endotoxemia
Primary: Mortality — 78; 84 Participants
N/A N=411 Evaluation of Moderate to Severe Influenza Outcomes in Children
Influenza · Otitis Media · Lower Resp Tract Infection
Primary: Hospitalization — 26; 2 Participants
Phase 3 N=1,200 STeroids to REduce Systemic Inflammation After Infant Heart Surgery
Congenital Heart Disease in Children · Inflammatory Response
Primary: Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome — 12; 17; 3; 7 Participants — p=0.14
Phase 3 N=422 The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure
Sepsis · Delirium · Impaired Cognition
Primary: Delirium/Coma Free Days (DCFDs) — 8; 7.5 days
N/A N=278 Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source
Fever Without Source
Primary: Antibiotic Prescription Rate — 54; 59 participants — p=1