Hypertonic Saline Dextran in Pediatric Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery

NCT04997291

Heart Defects, Congenital

UNKNOWN PHASE1

The Role of Dexmedetomidine As Myocardial Protection In Pediatric Cyanotic Congenital Heart Disease Undergoing Open Cardiac Surgery Using Cardiopulmonary Bypass Machine: A Preliminary Study

NCT05300802

Congenital Heart Disease in Children Cardiopulmonary Bypass

COMPLETED PHASE2/PHASE3

Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation

NCT02519335

Heart Defects, Congenital

TERMINATED PHASE1

The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease

NCT00480740

Cardiac Transplant Patent Ductus Arterious Atrial Septal Defect +1 more

COMPLETED PHASE3

Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease

NCT00590018

Cardiac Output, Low

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After major cardiac surgery in small children, extravasation of fluid due to increased capillary leak has negative effect on haemodynamics and respiration. Inflammation cascades are activated by surgery and the use of cardio pulmonary bypass (CPB). We want to test whether a small infusion of 7.5% NaCl in 6% dextran solution before and after CPB reduces inflammatory activation by measuring the levels of interleukins 6 and 8 (IL-6, IL-8). We also measure extravascular lung water, fluid balance and weight during the first 24 hours post CPB.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Defects, Congenital Transposition of Great Vessels Heart Septal Defects, Ventricular Endocardial Cushion Defects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

7.5% NaCl in 6% dextran 70 solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with congenital heart defect undergoing surgery using cardio pulmonary bypass (CPB).
* Age below 17 weeks

Exclusion Criteria

* Preoperative: organ failure (other than heart), serum sodium \> 155 mmol/l, central venous pressure \> 12 mmHg
* Perioperative: core temperature \< 25 ºC on CPB, re-heparinization, re-operation

Maximum Eligible Age

16 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No