Hypertonic Saline-hetastarch in Cardiac Surgery

NCT ID: NCT00469716

Last Updated: 2016-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-05-31

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.

Conditions

Postoperative Cardiorespiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marit Farstad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dep. of Anesthesia and Intensive Care, Haukeland University Hospital, 5021 Bergen , Norway

Locations

Section for thoracic and cardiovascular surgery, Haukeland University Hospital

Bergen, , Norway

Countries

Norway

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 12735579 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9477053 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8102722 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8109757 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14759446 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16879469 (View on PubMed)

Other Identifiers

15789

Identifier Type: -

Identifier Source: org_study_id