Effect of Prime Solution on Fluid Balance After Open Heart Surgery

Phase 4

Completed

• Conditions: Valve Surgery; Coronary Artery Bypass Grafting
• Interventions: Drug: Ringer lactate; Drug: HES

• Registration Number: NCT00797589
• Lead Sponsor: University of Helsinki

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Study Start: 2009-01
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Elective combined cardiac surgery

Exclusion Criteria

• Liver failure
• Kidney failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer lactate	Ringer lactate	Crystalloid solution
HES solution (Tetraspan®)	HES	Balanced colloid solution

Primary Outcome Measures

Name	Time	Method
fluid balance	1 postoperative day

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland