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NCT00797589 Clinical Trial

Effect of Prime Solution on Fluid Balance After Open Heart Surgery

Coronary Artery Bypass Grafting Clinical Trial

Official title:
Effect of Prime Solution on Fluid Balance After Open Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00797589
Other study ID # 2008-001225-34
Secondary ID
Status Completed
Phase Phase 4
First received November 24, 2008
Last updated August 24, 2015
Start date January 2009
Est. completion date September 2012

Study information
Verified date August 2015
Source Helsinki University
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

The use of Tetraspan® as prime solution can reduce fluid extravasation after perfusion versus Ringer acetate. Plasma-adapted HES-solutions produce also less acidosis.

Description:

Fifty patients scheduled for elective primary and single cardiac surgery include in this prospective study. Patients with preoperative coagulation disorders, or renal or hepatic failure, are excluded.

Before admission to the operation theatre, the patients allocate in random order to receive one of the following solutions during the extracorporeal circulation:

1. Ringer-acetate solution

2. 6% HES solution (Tetraspan®) During the 1 postoperative day we register hemodynamic changes, fluid balance, fluid extravasation, plasma ion concentration, modified thromboelastography, and kidney function.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elective combined cardiac surgery

Exclusion Criteria:

- Liver failure

- Kidney failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• HES
20ml/kg as prime fluid
• Ringer lactate

Locations
Country Name City State
Finland Helsinki University Central Hospital Helsinki

Sponsors (2)
Lead Sponsor Collaborator
Helsinki University B. Braun Melsungen AG

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary fluid balance 1 postoperative day Yes
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