Hypertonic Saline-Hetastarch in Cardiac Surgery - Full Text View

Sponsored by:	Haukeland University Hospital
Information provided by:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00469716

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 IV

MedlinePlus related topics: Heart Surgery Surgery

Drug Information available for: Hetastarch

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Infusion of Hypertonic Saline-Hetastarch in Cardiac Surgery

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

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:

Mehlhorn U, Geissler HJ, Laine GA, Allen SJ. Myocardial fluid balance. Eur J Cardiothorac Surg. 2001 Dec;20(6):1220-30. Review.

Kumle B, Boldt J, Suttner SW, Piper SN, Lehmann A, Blome M. Influence of prolonged cardiopulmonary bypass times on splanchnic perfusion and markers of splanchnic organ function. Ann Thorac Surg. 2003 May;75(5):1558-64.

Harris DN, Oatridge A, Dob D, Smith PL, Taylor KM, Bydder GM. Cerebral swelling after normothermic cardiopulmonary bypass. Anesthesiology. 1998 Feb;88(2):340-5.

Harris DN, Bailey SM, Smith PL, Taylor KM, Oatridge A, Bydder GM. Brain swelling in first hour after coronary artery bypass surgery. Lancet. 1993 Sep 4;342(8871):586-7.

McDaniel LB, Nguyen T, Zwischenberger JB, Vertrees R, Uchida T, Kramer GC. Hypertonic saline dextran prime reduces increased intracranial pressure during cardiopulmonary bypass in pigs. Anesth Analg. 1994 Mar;78(3):435-41.

Bueno R, Resende AC, Melo R, Neto VA, Stolf NA. Effects of hypertonic saline-dextran solution in cardiac valve surgery with cardiopulmonary bypass. Ann Thorac Surg. 2004 Feb;77(2):604-11; discussion 611.

Farstad M, Haugen O, Kvalheim VL, Hammersborg SM, Rynning SE, Mongstad A, Nygreen E, Husby P. Reduced fluid gain during cardiopulmonary bypass in piglets using a continuous infusion of a hyperosmolar/hyperoncotic solution. Acta Anaesthesiol Scand. 2006 Aug;50(7):855-62.

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

Keywords provided by Haukeland University Hospital:

Fluid balance
respiratory function
cardiac function
inflammation
Cardiopulmonary bypass

Study placed in the following topic categories:

Hetastarch
Plasma Substitutes
Inflammation

Additional relevant MeSH terms:

Therapeutic Uses
Hematologic Agents
Blood Substitutes

Hetastarch
Plasma Substitutes
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009