Effect of Prime Solution on Fluid Balance After Open Heart Surgery

University of Helsinki

Status and phase: Completed; Phase 4

Conditions: Valve Surgery; Coronary Artery Bypass Grafting

Treatments: Drug: HES; Drug: Ringer lactate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00797589

2008-001225-34

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective combined cardiac surgery

Exclusion criteria

• Liver failure
• Kidney failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Ringer lactate

Experimental group

Description:

Crystalloid solution

Treatment:

Drug: Ringer lactate

HES solution (Tetraspan®)

Experimental group

Description:

Balanced colloid solution

Treatment:

Drug: HES