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Endocardial Cushion Defects clinical trials

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NCT ID: NCT05253209 Recruiting - Clinical trials for Ventricular Septal Defect

A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects

Start date: June 29, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.

NCT ID: NCT01825369 Withdrawn - Clinical trials for Heart Septal Defects, Ventricular

Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow

L-carn
Start date: December 2014
Phase: Phase 1
Study type: Interventional

Infants with congenital heart disease and increased pulmonary blood flow have altered carnitine homeostasis that is associated with clinical outcomes; and L-carnitine treatment will attenuate these alterations and improve clinical outcomes. The investigators will pilot a trial assessing the safety and pharmacokinetics of perioperative IV L-carnitine administration in these patients. To this end, a pilot clinical trial is proposed. Infants with ventricular septal defects or atrioventricular septal defects undergoing complete surgical repair will receive L-carnitine (25, 50, or 100 mg/kg, IV) just prior to cardiopulmonary bypass (CPB) and 2hr after CPB. Carnitine levels will be measured before CPB, and before and 0.5, 1.5, 3, 5, 9, 12, and 24h after the second dose. The safety, pharmacokinetic profile, feasibility, and effect of L-carnitine administration on biochemical parameters, as well as clinical outcomes will be determined. The investigators expect this pilot to provide the data needed to proceed with a placebo-based randomized, controlled, trial.

NCT ID: NCT01120964 Completed - Clinical trials for Atrial Septal Defect

Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol

Start date: September 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery. Participants will be randomly assigned to either L-citrulline or a placebo (a substance that has no medicine in it). Citrulline is a protein building block in the body that can convert into another substance, nitric oxide (NO), which controls blood pressure in the lungs. Increased blood pressure in the lungs can be an important surgical problem; it may also lead to problems following surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased time spent on a breathing machine, and a longer stay in the intensive care unit (ICU). The hypothesis of this study is that perioperative supplementation with intravenous citrulline will increase plasma citrulline, arginine and NO metabolites and prevent elevations in the postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical ventilation. The objective of this study is to determine in a randomized placebo controlled phase IB multicenter clinical trial if a revised protocol of intravenous L-citrulline delivery given perioperatively achieves a plasma citrulline level of > 100 umol/L in children undergoing surgical repair of an atrial septal defect,ventricular septal defect or an atrioventricular septal defect.

NCT ID: NCT00848393 Completed - Clinical trials for Tetralogy of Fallot (TOF)

Measures to Lower the Stress Response in Pediatric Cardiac Surgery

Start date: November 2008
Phase: Phase 2
Study type: Interventional

Cardiac surgery induces a measurable stress response in patients which leads to increased morbidity and mortality post-operatively. Through clinical observation, anesthesiologists have determined that varying the combinations of anesthesia drugs used during surgery and just after reduces the stress response, and by extension, morbidity and mortality. However, only a few studies have explored this phenomenon scientifically.

NCT ID: NCT00327951 Terminated - Clinical trials for Congenital Disorders

Infant Weight Gain With Trisomy 21 and CAVC

Start date: January 2001
Phase: N/A
Study type: Observational

Failure to thrive and difficulty gaining weight is a sign of uncompensated congestive heart failure (CHF). Infants with Trisomy 21 and complete atrioventricular canal defects (CAVC) frequently develop uncompensated CHF and weight gain failure pre-operatively. A weight of 5 kg has been suggested as optimal for timing of CAVC repair. A delay in surgical repair often occurs if weight gain stalls and reaches a plateau prior to reaching 5 kg. A retrospective review performed by Kogon, et al, of children undergoing surgery for VSD at CHOA at Egleston recently reported that age and weight at surgery may not, however, be associated with adverse surgical outcome. The purpose of this study is to determine the optimal timing for surgical correction of CAVC in Trisomy 21 infants based on reaching a plateau of failed weight gain despite maximal anti-congestive and nutritional therapy.

NCT ID: NCT00229827 Terminated - Clinical trials for Ventricular Septal Defects

Optimal Timing for Repair of Left to Right Shunt Lesions

Start date: May 2005
Phase: N/A
Study type: Observational

The purpose of this study is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals.

NCT ID: NCT00199771 Completed - Clinical trials for Heart Defects, Congenital

Hypertonic Saline Dextran in Pediatric Cardiac Surgery

Start date: June 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children.

NCT ID: NCT00005546 Completed - Clinical trials for Cardiovascular Diseases

Molecular Genetic Epidemiology of Three Cardiac Defects -SCOR in Pediatric Cardiovascular Disease

Start date: January 1999
Phase: N/A
Study type: Observational

To identify genes involved in the pathogenesis of three types of congenital heart disease, atrial septal defects, paramembranous ventricular septal defects, and atrioventricular canal defects.

NCT ID: NCT00005322 Completed - Clinical trials for Cardiovascular Diseases

Molecular Genetic Epidemiology of Endocardial Cushion Defects - SCOR in Pediatric Cardiovascular Disease

Start date: January 1990
Phase: N/A
Study type: Observational

To identify genes involved in the pathogenesis of congenital heart disease, including atrial septal defects (ASDs), paramembranous ventricular septal defects (VSDs), and atrioventricular canal defects (AVCDs).