Clinical trials: Pediatric Open Heart Surgery
Cardiac Surgery Recovery, Inflammation
Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries
This prospective single-center randomized controlled trial aims at evaluating the safety and feasibility of an hemoadsorption protocol using Jafron HA-60 during cardio-pulmonary bypass in 20 pediatric patients undergoing…
- Conditions
- Cardiac Surgery Recovery, Inflammation, Complex Cardiovascular Surgery With Cardiopulmonary Bypass, Cytokine Storm
- Trial name
- JACKPOT (NCT07393087)
- Testing
- Hemoadsorption
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois
Anesthesia, Local
Efficacy of iv Fentanyl Citrate Administered Oral as a Pediatric Premedication
evaluate the efficacy of the intravenous formulation of fentanyl citrate administered orally as a sedative premedication, we will compare it with oral midazolam, as a gold standard premedication, in paediatric congenital cardiac…
- Trial name
- NCT04991298
- Testing
- Oral premedication
- Where
- 2 sites in Egypt
- Volunteers
- 60 people
- Sponsor
- University of Alexandria
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
Coronary Syndrome, Pediatric
Cerebral Oxygenation and Burst Suppression
investigators want to observe a group of pediatric patients who are going to undergo open thoracic surgery at Queen Silvia's child and youth hospital, Sahlgrenska University Hospital.
- Trial name
- NCT04206683
- Where
- Sweden
- Volunteers
- 15 people
- Sponsor
- Göteborg University
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Congenital Heart Disease, Open Heart Surgery
Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)
The Localized Evidence of Cytokine Adsorption Therapy (LEAT) study is a prospective, randomized controlled trial conducted at the Institut Jantung Negara in Malaysia.
- Conditions
- Congenital Heart Disease, Open Heart Surgery, Cardiopulmonary Bypass, Endocarditis Acute and Subacute
- Trial name
- LEAT (NCT07771491)
- Testing
- Hemoadsorption (Jafron HA-60/HA380)
- Volunteers
- 120 people
- Sponsor
- Norfaniza Zabidi
Acute Kidney Injury
Preventing Acute Kidney Injury (AKI) in Pediatric Patients
The purpose of this study is to compare the effects of peri-operative administration of Aminophylline versus Saline placebo in the preservation of renal function and the attenuation of renal injury in pediatric patients…
- Trial name
- AKI (NCT03897335)
- Testing
- Aminophylline
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Le Bonheur Children's Hospital
Congenital Heart Disease in Children
BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)
Congenital heart disease occurs in about 1% of live births and can range from (1) naturally curable conditions that require no treatment to (2) conditions that require multiple immediate operations or refractory severe…
- Trial name
- NCT05647161
- Testing
- BAX602, No Intervention
- Where
- 6 sites in Japan
- Volunteers
- 34 people
- Sponsor
- Baxter Healthcare Corporation
Postoperative Pain, Pediatric Open Heart Surgery
A Combination of Intrathecal Fentanyl and Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery.
Cardiac surgery is commonly performed via median sternotomy. Patients undergoing cardiac surgical procedures frequently experience intense acute pain in the post-sternotomy wound, which can potentially transition into persistent…
- Trial name
- NCT06882655
- Testing
- PIFB group, Intrathecal fentanyl(IT fentanyl), IT + PIFB
- Where
- 2 sites in Egypt
- Volunteers
- 90 people
- Sponsor
- Alexandria University
Congenital Heart Disease in Children, Cardiopulmonary Bypass
The Role of Dexmedetomidine As Myocardial Protection In Pediatric Cyanotic Congenital Heart Disease Undergoing Open Cardiac Surgery Using Cardiopulmonary Bypass Machine: A Preliminary Study
Congenital Heart Diseases (CHD) are one of the most common congenital anomalies. Worldwide, 8 to 9 out of 1000 of children are born with a CHD, of which 25 percent of are cyanotic CHD.
- Trial name
- NCT05300802
- Testing
- Dexmedetomidine Hcl 100 Mcg/mL Inj
- Where
- Indonesia
- Volunteers
- 15 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Acute Hypokalemia
Comparison of Enteral Versus Intravenous Potassium Supplementation
Null hypothesis: There is no difference in the efficacy of IVPR and EPR during an episode of hypokalemia. Alternate Hypothesis: There is a mean difference of 15% in Serum Potassium levels between the two groups.
- Trial name
- EIPS (NCT02015962)
- Testing
- Intravenous potassium chloride, Oral potassium chloride
- Where
- 3 sites in Pakistan
- Volunteers
- 40 people
- Sponsor
- Aga Khan University
Cyanotic Heart Disease, Cardiopulmonary Bypass
Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
The goal of this study is to evaluate the effects of steroids on the early postoperative inflammatory response in patients undergoing elective pediatric congenital cardiac surgery, requiring cardiopulmonary bypass (CPB).
- Trial name
- NCT05927233
- Testing
- Methylprednisolone, Saline
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Aga Khan University
Liver Surgery, Liver Dysfunction
Octaplas Pediatric Plasma Replacement Trial
The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors.
- Conditions
- Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
- Trial name
- NCT02050841
- Testing
- octaplas
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Octapharma
Open-heart Surgery, Cardiopulmonary Bypass
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine is safe.
- Trial name
- NCT00569855
- Testing
- Phenoxybenzamine
- Where
- United States
- Volunteers
- 785 people
- Sponsor
- University of Arkansas
Postoperative Pain
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs.
- Trial name
- NCT06271265
- Testing
- EXPAREL, bupivacaine
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Congenital Heart Disease
Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery
Background: Children having open heart surgery to repair congenital heart defects demonstrate a large inflammatory response to the heart-lung machine and to surgery itself.
- Trial name
- NCT00693498
- Testing
- Standard leukoreduced irradiated blood cell transfusion, Washed leukoreduced irradiated blood cell transfusions
- Volunteers
- 162 people
- Sponsor
- University of Rochester
Congenital Heart Diseases
Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease 2.
- Trial name
- NCT02527811
- Testing
- Ulinastatin
- Where
- 5 sites in China
- Volunteers
- 450 people
- Sponsor
- Techpool Bio-Pharma Co., Ltd.
Hematologic Changes
Effect of Blood Harvesting and Administration at End of CPB on Coagulation Profile
Blood transfusions after pediatric heart surgery is a relatively common practice occurring in up to 46% of patients, however its use has been associated with increased morbidity.
- Trial name
- NCT01958242
- Testing
- Preoperative blood harvesting
- Where
- Israel
- Sponsor
- Rabin Medical Center
Pectointercostal Fascial Plane Block
Parasternal Block in Pediatric Patients Undergoing Cardiac Surgery
The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block in children undergoing congenital heart surgery is associated with differences in outcomes when compared to…
- Trial name
- NCT05539885
- Testing
- Pre-incisional Ultrasound guided (PIFP) block, Post-incisional Surgeon delivered parasternal block group
- Volunteers
- 80 people
- Sponsor
- Assiut University
Heart Defects, Congenital, Myocardial Reperfusion Injury
Morphine Versus Fentanyl for Myocardial Protection in Acyanotic Children Undergoing Congenital Open-Heart Surgery
This study compared two opioid pain medications - morphine and fentanyl - used during open-heart surgery in young children born with heart defects (congenital heart disease).
- Trial name
- MorphPed (NCT07839273)
- Testing
- Fentanyl (IV), morphine
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people
- Sponsor
- Baskent University