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Hypertonic Saline-hetastarch in Cardiac Surgery (HH)

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ClinicalTrials.gov Identifier: NCT00469716
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : August 24, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Cardiorespiratory Failure Drug: Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5) Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Infusion of Hypertonic Saline-hetastarch in Cardiac Surgery
Study Start Date : April 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008
Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469716

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

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00469716     History of Changes
Other Study ID Numbers: 15789
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

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

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes