Clinical trials: Pediatric Congenital Heart Surgery
Transposition of the Great Arteries, Tetralogy of Fallot
A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery…
- Conditions
- Transposition of the Great Arteries, Tetralogy of Fallot, Ventricular Septal Defect
- Trial name
- NCT01915277
- Testing
- Dexmedetomidine
- Where
- 4 sites in United States
- Volunteers
- 119 people
- Sponsor
- Carelon Research
Congenital Heart Defects
Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery
We conducted a multicenter, randomized, placebo-controlled trial of Cylexin, an inhibitor of the attachment of white blood cells to the endothelium.
- Trial name
- NCT00226369
- Testing
- CY-1503
- Where
- United States
- Volunteers
- 242 people
- Sponsor
- Boston Children's Hospital
Congenital Heart Disease
High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery
Malformations of the heart are common; 1.35 million infants are born each year with congenital heart disease. Many of these defects carry a considerable threat to the individual's quality of life as well as survival.
- Trial name
- ULTRA (NCT04920643)
- Testing
- Ultrafiltration
- Where
- Canada
- Volunteers
- 104 people
- Sponsor
- IWK Health Centre
Acute Kidney Injury, Congenital Heart Disease
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass.
- Trial name
- NCT02046135
- Testing
- Sodium Bicarbonate, Sodium Chloride
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Northwell Health
Iron Deficiencies, Iron Deficiency Anemia
Iron Deficiency in Pediatric Heart Surgery
The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates.
- Conditions
- Iron Deficiencies, Iron Deficiency Anemia, Cardiac Surgical Procedures, Congenital Heart Disease in Children
- Trial name
- NCT06276608
- Testing
- Iron status
- Where
- Belgium
- Volunteers
- 300 people
- Sponsor
- Queen Fabiola Children's University Hospital
Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy
Comparison of Erector Spinae Plane Block and Modified Pectoral Fascial Plane Block for Postoperative Analgesia in Pediatric Cardiac Surgery
Postoperative pain management is an essential component of perioperative care in pediatric congenital cardiac surgery. Regional anesthesia techniques, including the erector spinae plane block (ESPB) and modified pectoral fascial…
- Conditions
- Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy, Anesthesia
- Trial name
- NCT07740915
- Testing
- Ultrasound-Guided Erector Spinae Plane Block, Ultrasound-Guided Modified Pectoral Fascial Plane Block
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Microcirculation
Microcirculatory Alteration by a Vascular Occlusion Test Using Near-infrared Spectroscopy in Pediatric Cardiac Surgery
Cardiopulmonary bypass cause microcirculatory alterations. Near infrared spectroscopic measurement of tissue oxygen saturation and vascular occlusion test are novel technologies for assessing the microcirculatory function of…
- Trial name
- NCT06191913
- Testing
- Near-infrared spectroscop
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Hemolysis
Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major
Authors compared incidence of Hemolysis on Cardiopulmonary Bypass surgery for repair of congenital heart disease in Pediatric Patients between patients with thalassemia major and control group
- Trial name
- NCT04367701
- Testing
- Hemolysis
- Volunteers
- 41 people
- Sponsor
- Ain Shams University
Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates…
- Conditions
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Single Ventricle Defect, Stress, Psychological
- Trial name
- NCT02462434
- Testing
- Early palliative care team consultation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
Vitamin D Deficiency, Thoracic Surgery
Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level
Our research group has shown that almost all children with congenital heart disease (CHD) are vitamin D deficient following heart surgery.
- Conditions
- Vitamin D Deficiency, Thoracic Surgery, Pediatric Disorders, Heart Defects, Congenital
- Trial name
- HICCUPS 2 (NCT01838447)
- Testing
- Cholecalciferol
- Where
- Canada
- Volunteers
- 46 people
- Sponsor
- Children's Hospital of Eastern Ontario
Congenital Heart Disease
Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia
The increase in internal diameter (ID) and cross-sectional area (CSA) may facilitate better arterial catheterization. Since an increase in body temperature can cause peripheral vasodilation, we aimed to determine if local warming…
- Trial name
- WARM-PA (NCT06041685)
- Testing
- local warming
- Where
- South Korea
- Volunteers
- 126 people
- Sponsor
- Pusan National University Yangsan Hospital
Pediatric Cardiac Surgery, Complication of Extracorporeal Circulation
A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery
The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolytic drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing pediatric cardiac surgery.
- Trial name
- TXAEACA (NCT02656472)
- Testing
- Tranexamic acid, Epsilon Aminocaproic Acid
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Wake Forest University Health Sciences
Aortic Coarctation, Cardiac Output, Low
Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery
This prospective observational study aims to evaluate the correlation between cardiac index measured by the MostCare™ system (Pressure Recording Analytical Method, PRAM) and cerebral/renal regional oxygen saturation measured by…
- Trial name
- MostCare-Ped (NCT07568431)
- Testing
- MostCare (PRAM), Near-Infrared Spectroscopy (NIRS), Arterial Blood Gas with Lactate
- Where
- Turkey (Türkiye)
- Volunteers
- 43 people
- Sponsor
- Konya City Hospital
Congenital Cardiomyopathy
Neuropsychomotor Development From Ages 6 to 18 in Children With Early Surgically Treated Congenital Heart Disease
This study will invite parents of children who underwent surgical treatment for congenital heart disease to complete a validated proxy-report questionnaire assessing executive and psychosocial functioning.
- Trial name
- NEUROTECH (NCT07437261)
- Testing
- Questionnaire
- Where
- 2 sites in France
- Volunteers
- 155 people
- Sponsor
- University Hospital, Toulouse
Single Ventricle
Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
The purpose of this study is to test the efficacy of treprostinil (TRE) in the perioperative non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube drainage (in days).
- Trial name
- NCT02498444
- Testing
- Treprostinil
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Stanford University
Congenital Heart Disease
Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs.
- Trial name
- NCT00850720
- Testing
- Blood draws
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Emory University
Congenital Heart Disease in Children
Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization
Children undergoing cardiac surgery or cardiac catheterization often experience significant stress and anxiety during the preoperative period.
- Trial name
- GETREADY (NCT07414251)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Charite University, Berlin, Germany
Myocardial Ischemia, Heart Defects, Congenital
Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric…
- Conditions
- Myocardial Ischemia, Heart Defects, Congenital, Reperfusion Injury, Myocardial
- Trial name
- NCT07785141
- Where
- Finland
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Heart Ischemia, Cerebral Ischemia
Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease
Cardiac surgery is associated with risk of perioperative inflammation and ischemia leading to cerebral and myocardial morbidity and mortality.
- Trial name
- RIPHeart (NCT01312623)
- Testing
- Remote ischemic preconditioning
- Where
- Germany
- Volunteers
- 31 people
- Sponsor
- University Hospital Schleswig-Holstein
AKI - Acute Kidney Injury, Arrythmia
Tailored MgSO4 Supplementation to Reduce Complications in Pediatric Heart Surgery
Lay Summary This study tests two ways of measuring blood magnesium after heart surgery. Children who need heart surgery may have heart and kidney problems after surgery. The right amount of magnesium in blood reduces this risk.
- Conditions
- AKI - Acute Kidney Injury, Arrythmia, Congenital Heart Disease
- Trial name
- NCT06564376
- Testing
- total magnesium, ionized magnesium
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- West Virginia University