Hypertonic Saline-hetastarch in Cardiac Surgery

Postoperative Cardiorespiratory Failure Clinical Trial

— HH  

Official title:

Infusion of Hypertonic Saline-hetastarch in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469716
• Other study ID #: 15789
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2007
• Last updated: August 23, 2016
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: August 2016
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Cardiorespiratory Failure

Intervention

Drug:
• Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5)

Locations

Country	Name	City	State
Norway	Section for thoracic and cardiovascular surgery, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. Retraction in: Ann Thorac Surg. 2011 Jul;92(1):412. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume		12 hours
Secondary	Time to extubation, fluid balance, paO2/FiO2- ratio, frequency of atrial fibrillation, cytokines, time to ICU-release and hospital release.