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Effect of Prime Solution on Fluid Balance After Open Heart Surgery

Effect of Prime Solution on Fluid Balance After Open Heart Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00797589
Enrollment
35
Registered
2008-11-25
Start date
2009-01-31
Completion date
2012-09-30
Last updated
2015-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valve Surgery, Coronary Artery Bypass Grafting

Keywords

aorta valve, mitral valve, coronary artery bypass grafting surgery, perfusion, priming

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.

Interventions

DRUGHES

20ml/kg as prime fluid

DRUGRinger lactate

Sponsors

B. Braun Melsungen AG
CollaboratorINDUSTRY
University of Helsinki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elective combined cardiac surgery

Exclusion criteria

* Liver failure * Kidney failure

Design outcomes

Primary

MeasureTime frame
fluid balance1 postoperative day

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026