Clinical trial NCT00469716: Hypertonic Saline-hetastarch in Cardiac Surgery
Official title: Infusion of Hypertonic Saline-hetastarch in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Cardiorespiratory Failure
Keywords: Fluid balance
respiratory function
cardiac function
inflammation
Cardiopulmonary bypass
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2007-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Cardiac output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume
timeFrame: 12 hours
Secondary outcomes:
measure: Time to extubation, fluid balance, paO2/FiO2- ratio, frequency of atrial fibrillation, cytokines, time to ICU-release and hospital release.
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Section for thoracic and cardiovascular surgery, Haukeland University Hospital
Study officials:
affiliation: Dep. of Anesthesia and Intensive Care, Haukeland University Hospital, 5021 Bergen , Norway
name: Marit Farstad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehlhorn U, Geissler HJ, Laine GA, Allen SJ. Myocardial fluid balance. Eur J Cardiothorac Surg. 2001 Dec;20(6):1220-30. doi: 10.1016/s1010-7940(01)01031-4.
citation: 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. doi: 10.1016/s0003-4975(02)04903-2.
citation: 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. doi: 10.1097/00000542-199802000-00011.
citation: 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. doi: 10.1016/0140-6736(93)91412-f.
citation: 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. doi: 10.1213/00000539-199403000-00003.
citation: 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. doi: 10.1016/S0003-4975(03)01486-3.
citation: 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. doi: 10.1111/j.1399-6576.2006.01064.x.