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Completed

NCT Number: NCT00199771

Hypertonic Saline Dextran in Pediatric Cardiac Surgery

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.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocardial Cushion Defects Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular Transposition of Great Vessels

Age range

Up to 16 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7.5% NaCl in 6% dextran 70 solution

Drug

Primary outcomes

  1. IL-6 and IL-8 2 hours post CPB

  2. Extra vascular lung water 2 and 24 hours post CPB

Secondary outcomes

  1. Fluid balance

  2. Weight gain

  3. Cardiac output

  4. Intrathorasic blood volume

  5. Blood pressure during the first 24 hours post CPB

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • BioPhausia

Registry information

Official study title

The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old.

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Jul 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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