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OpenTrials
Completed

NCT Number: NCT00797589

Effect of Prime Solution on Fluid Balance After Open Heart Surgery

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

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Key information

Conditions

Valve Surgery Coronary Artery Bypass Grafting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Central Hospital

Helsinki, 00029, Finland

About this study

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:

  • Ringer-acetate solution
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective combined cardiac surgery

Exclusion criteria

  • Liver failure
  • Kidney failure

Treatment and study plan

HES

Drug

20ml/kg as prime fluid

Ringer lactate

Drug

Primary outcomes

  1. fluid balance

    Time frame: 1 postoperative day

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • B. Braun Melsungen AG

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 25, 2008
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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