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Hypertonic Saline-Hetastarch in Cardiac Surgery (HH)

This study has been completed.
Sponsor:
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00469716
First received: May 3, 2007
Last updated: December 15, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Postoperative Cardiorespiratory Failure
Drug: Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Infusion of Hypertonic Saline-Hetastarch in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Cardiac output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume [ Time Frame: 12 hours ]

Secondary Outcome Measures:
  • Time to extubation, fluid balance, paO2/FiO2- ratio, frequency of atrial fibrillation, cytokines, time to ICU-release and hospital release.

Estimated Enrollment: 50
Study Start Date: April 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients scheduled for elective coronary artery bypass graft surgery

Exclusion Criteria:

  • Age <18 years or > 75 years
  • BMI< 18 or > 30
  • Left ventricular ejection fraction < 40%
  • Emergency operations
  • Additional valvular diseases
  • Impaired renal function
  • Serum sodium> 145 mmol/l
  • Hematocrit< 30%
  • Use of clopidogrel the last 5 days
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00469716

Locations
Norway
Section for thoracic and cardiovascular surgery, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Marit Farstad, MD, PhD Dep. of Anesthesia and Intensive Care, Haukeland University Hospital, 5021 Bergen , Norway
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00469716     History of Changes
Other Study ID Numbers: 15789
Study First Received: May 3, 2007
Last Updated: December 15, 2008
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Haukeland University Hospital:
Fluid balance
respiratory function
cardiac function
inflammation
Cardiopulmonary bypass

ClinicalTrials.gov processed this record on November 24, 2014