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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.


Clinical Trial 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. ;


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


NCT number NCT00797589
Study type Interventional
Source Helsinki University
Contact
Status Completed
Phase Phase 4
Start date January 2009
Completion date September 2012

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