Phase 3 N=2,203 Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
Ischemic Heart Disease
Primary: Short-term End Point — 61; 77 participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=18 Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB)
Complication of Extracorporeal Circulation · Renal Impairment
Primary: Renal Blood Flow (RBF) — 554; 524; 564; 558 ml per minute per 1.73 m2 body surface — p=0.638
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
Phase 3 N=46 Cytokine Removal in Cardiopulmonary Bypass Patients
Elective Cardiac Surgical Interventions
Primary: IL-6 — 0; 0; 0; 0 pg/ml
N/A N=164 Extracardiac Complications After Cardiac Surgery
Acute Lung Injury · Sepsis · Infections
Primary: Acute Lung Injury After Cardiac Surgery — 20 participants — p=<0.05
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
Phase 3 N=115 Bradykinin Receptor Antagonism During Cardiopulmonary Bypass
Cardiopulmonary Bypass · Inflammation · Fibrinolysis
Primary: Allogenic Blood Product Transfusion Risk — 47.4; 56.8; 52.5; 36.8 percentage of participants — p=0.72
Phase 4 N=86 The RAS, Fibrinolysis and Cardiopulmonary Bypass
Coronary Artery Disease · Angiotensin Converting Enzyme · Angiotensin Receptor Blockers
Primary: Tissue-type Plasminogen Activator (t-PA) Antigen Response — 14.36; 14.05; 11.97; 27.65 ng/mL — p=0.28
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=14 Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.
Hypothermia · Rewarming
Primary: Time to Normothermia — 4.4 hours
Phase 4 N=411 On Versus Off Pump Myocardial Revascularization Study
Coronary Artery Disease
Primary: Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following) — 13; 26 participants
Phase 2 N=448 Myocardial Protection With Multiport Antegrade Cold Blood Cardioplegia
Coronary Artery Bypass Surgery
Primary: Post-op CK-MB Levels — 71.70; 92.66 IU/L — p=<0.05
N/A N=336 Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
Ischemic Heart Disease · Coronary Artery Disease · Ischemic Reperfusion Injury
Primary: Myeloperoxidase — 184.3; 66.5; 144.71 g/L
N/A N=32 CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass
Heart Failure
Primary: Survival — 20 Participants
N/A N=301 Balloon Pump Assisted Coronary Intervention Study
Coronary Artery Disease · Left Ventricular Dysfunction
Primary: Major Adverse Cardiac and Cerebrovascular Events — 23; 24 Participants
Phase 3 N=30 Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery
Late Effects of Surgery · Staphylococcus Aureus · Surgical Site Infection
Primary: Mean Daptomycin Concentrations at 12, 18, 24, and 48 h — 22.7; 16.2; 12.0; 3.5 mcg/ml
N/A N=100 The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass
Blood Coagulation Disorders
Primary: Amount of Chest Catheter Drainage 24 Hours Postoperatively — 766; 626 mL
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
N/A N=70 Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery
Hypertension
Primary: Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour — 97.9; 45.6 mmHg*min/prebypass hour — p=0.21
Phase 4 N=314 Effects of Microplegia on Transfusion Rates After Cardiac Surgery
Aortic Valve Disease · Mitral Valve Disease
Primary: Intraoperative and Postoperative Transfusions — 2.43; 2.97; 4.42; 3.50 units of blood per participant — p=0.354
Phase 4 N=46 Platelet Transfusion During Neonatal Open Heart Surgery
Cardiac Disease · Cardiac Surgery · Cardiopulmonary Bypass
Primary: Amount of Blood Products Transfused — 58; 103 milliliter per kilogram (mL/kg)
N/A N=50 Post-bypass Prophylactic IVIG in Infants and Neonates
Hypogammaglobulinemia · Congenital Heart Disease
Primary: Post-Operative Infections — 9; 6; 21; 14 subjects — p=1
Phase 2 N=785 Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
Open-heart Surgery · Cardiopulmonary Bypass
Primary: Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively…
Phase 2 N=200 Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
Acquired Antithrombin III Deficiency · Coronary Artery Bypass
Primary: Postoperative ATIII Levels at the ICU Admission — 94.06; 64.70 IU — p=<0.0001
Phase 4 N=40 Fibrinolysis Before Cardiopulmonary Bypass?
Pathologic Fibrinolysis
Primary: Di-Dimer Increase Before Cardiopulmonary Bypass — 317; 266; 317; 291 ng/mL
N/A N=25 Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
Post-Op Complication
Primary: Infants With Elevated s100b and NSE — 11; 9 Participants
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
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
N/A N=200 Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients
Coronary Artery Disease · Postoperative Cognitive Dysfunction · Neurological Impairment
Primary: Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized…
Phase 2 N=40 The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.
Coronary Artery Disease · Edema
Primary: Extravascular Lung Water Index — 9; 8; 9; 8 mL/kg