N/A N=989 SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
Heart Defects, Congenital · Hyperglycemia
Primary: Incidence of Nosocomial Infections in the Cardiac ICU — 8.6; 9.9 infections / 1000 pt days
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=34 Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
Congenital Heart Defects
Primary: Cardiac Index — 3.39; 3.42; 3.23 L/min/m2
Phase 4 N=52 Regional Anesthesia Following Pediatric Cardiac Surgery
Atrial Septal Defect · Ventricular Septal Defect · Pain, Procedural
Primary: Total Amount of Opioid Medications Administered — 0.44; 0.83 MME/kg — p=0.001
Phase 2 N=60 Transfusion Strategies in Pediatric Cardiothoracic Surgery
Congenital Heart Disease
Primary: Mean Arterial Lactate Level — 1.4; 1.4 mmol/L
Phase 2 N=51 Measures to Lower the Stress Response in Pediatric Cardiac Surgery
Tetralogy of Fallot (TOF) · Ventricular Septal Defects (VSD) · Atrioventricular Septal Defects (AVSD)
Primary: ACTH and Cytokine Levels — 116.9; 182.7; 135.3; 44.5 pg/mL
N/A N=89 Pediatric Cardiac Output Monitoring Observational Study
Pediatric ALL
Primary: Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output — 0.49 L/min
Phase 2 N=35 Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
Congenital Heart Defect · Surgery-Induced Tissue Adhesions · Hemorrhage
Primary: Severity of Adhesions at the Retrosternal Site — 0; 31.3; 0; 37.5 percentage of participants
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=106 Ultrasound Guided Technique for Internal Jugular Central Venous Catheterization in Pediatric Cardiac Surgical Patients
Accidental Puncture of Artery During Catheter Insertion
Primary: Number of Attempts for Successful Central Venous Cannulation — 1.29 Attempts
Phase 2 N=30 Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study
Congenital Heart Disease
Primary: Change in Cytokine Levels — 4.38; 4.2; 3.98; 3.85 picograms per milliliter
N/A N=22 Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure
Hypoplastic Left Heart Syndrome
Primary: Time to First Post-operative Negative 24 Hour Fluid Balance — 2.7; 2.67 Days
Phase 4 N=32 Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
Congenital Heart Diseases · Aortic Valve Disorder
Primary: Number of Patients Who Receive Preoperative Vancomycin and Cefazolin Who Develop a Surgical Site Infection Compared to Those Whose Received Only Cefazolin. — 0; 0…
Phase 1 N=14 Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Hypoplastic Left Heart Syndrome · Single Ventricle · Heart Failure
Primary: Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells — 0; 0 participants
Phase 4 N=93 Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery
Pain
Primary: Total Fentanyl/Equivalent Day 0-1 — 23.6; 22.4 mcg/kg/day
Phase 4 N=30 Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
Hypofibrinogenemia · Afibrinogenemia · Bleeding Disorders
Primary: Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL)) — 35; 33 cc/kg
Phase 3 N=22 Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients
Orthotopic Heart Transplant
Primary: Coronary Flow Reserve (CFR) — 1.77 ratio: peak to baseline CFV
Phase 2 N=16 Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass
Congenital Heart Disease
Primary: Serum Inflammatory Mediators Post CPB — 3.8; 3.4; 90.9; 78.3 ng/mL — p=>0.05
Phase 2 N=62 Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
Congenital Heart Disease · Hypoplastic Left Heart Syndrome · Transposition of the Great Arteries
Primary: Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI — 12.1; 9.44 Percentage
N/A N=14 Modified Perfusion for Neonatal Aortic Arch Reconstruction
Aortic Arch Hypoplasia or Atresia
Primary: Intestinal Fatty Acid Binding Protein and C-reactive Protein
N/A N=13 Effects of Sternal Wall Pressure in Children
Respiration, Artificial
Primary: Sternal Force Associated With Change in Intrathoracic Pressure. — 2.8 kg
Phase 3 N=40 Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation
Inflammation · Platelet Dysfunction
Primary: Change in Platelet Count — -221; -242 Count of platelets — p=0.55
N/A N=144 Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Acute Kidney Injury
Primary: Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria — 43; 36 participants
N/A N=190 Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Congenital Heart Disease · Disorder of Fetus or Newborn
Primary: Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome — 27; 40 Participants
N/A N=5 Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
Heart Defects, Congenital
Primary: The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation. — 0 Participants
N/A N=555 Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
Heart Defects, Congenital
Primary: Proportion of Patients Who Died or Received a Heart Transplant — 100; 72 Participants — p=0.013
N/A N=40 Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass
Heart Disease Congenital Complex
Primary: Incidence of Low Cardiac Output Syndrome (LCOS) — 57; 26 percentage of patients — p=0.049
Phase 3 N=189 L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
Acute Lung Injury
Primary: A Composite Variable Consisting of the Longer of Either (1) Length of Time on Mechanical Ventilation or (2) Length of Inotrope Use. — 3351.1; 3549.6 Minutes — p=0.4930
N/A N=24 Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass
Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery · Inflammatory Reaction After Neonatal Cardiac Surgery
Primary: Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) — 0.46; 0.64; 11.52; 26.98 ng/ml — p=>0.05
N/A N=77 Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Congenital Heart Disease · Disorder of Fetus or Newborn
Primary: Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery…
N/A N=329 Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial
Cardiac Arrest
Primary: Survival With Good Neurobehavioral Outcome — 48; 48; 85; 76 Participants — p=0.63