Hypertonic Saline-Hetastarch in Cardiac Surgery (HH)
Cardiopulmonary bypass(CPB) is associated with increased fluid extravasation and edema formation. A continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch (HSH)during CPB reduced fluid extravasation and total fluid gain during bypass in an animal model. We hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions in patients undergoing coronary artery bypass with CPB.
Postoperative Cardiorespiratory Failure
Drug: Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Infusion of Hypertonic Saline-Hetastarch in Cardiac Surgery|
- Cardiac output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume [ Time Frame: 12 hours ]
- Time to extubation, fluid balance, paO2/FiO2- ratio, frequency of atrial fibrillation, cytokines, time to ICU-release and hospital release.
|Study Start Date:||April 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Cardiopulmonary bypass (CPB) is associated with fluid overload and edema formation occasionally resulting in vital organ dysfunction affecting heart, respiratory system , gastrointestinal tract and brain. Hyperosmolar/hyperoncotic preparations (HSH/HSD) have been used in cardiac surgery essentially with the aim to mobilize fluid excess and improve postoperative cardiorespiratory function.Most studies dealing with the administration of HSD or HSH during and after CPB, have used protocols recommended for treatment of severe hypovolemia and shock, that is 4 mL/kg as a bolus, given within minutes.In animal experiments we have used HSD or HSH, 1 mL/kg/h to a total dose of 4 mL/kg during CPB. The use of HSH/HSD reduced the total fluid gain about 50 % and resulted in significantly lower content of tissue water in vital organs as heart and lungs. In the actual clinical trial we hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions monitored with the PiCCO system in patients undergoing coronary artery bypass with CPB.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469716
|Section for thoracic and cardiovascular surgery, Haukeland University Hospital|
|Bergen, Norway, 5021|
|Principal Investigator:||Marit Farstad, MD, PhD||Dep. of Anesthesia and Intensive Care, Haukeland University Hospital, 5021 Bergen , Norway|