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Effect of Prime Solution on Fluid Balance After Open Heart Surgery

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ClinicalTrials.gov Identifier: NCT00797589
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : August 25, 2015
B. Braun Melsungen AG
Information provided by (Responsible Party):
Alexey Schramko, Helsinki University

November 24, 2008
November 25, 2008
August 25, 2015
January 2009
September 2012   (Final data collection date for primary outcome measure)
fluid balance [ Time Frame: 1 postoperative day ]
Same as current
Complete list of historical versions of study NCT00797589 on ClinicalTrials.gov Archive Site
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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
The use of Tetraspan® as prime solution can reduce fluid extravasation after perfusion versus Ringer acetate. Plasma-adapted HES-solutions produce also less acidosis.

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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Valve Surgery
  • Coronary Artery Bypass Grafting
  • Drug: HES
    20ml/kg as prime fluid
  • Drug: Ringer lactate
  • Experimental: Ringer lactate
    Crystalloid solution
    Intervention: Drug: Ringer lactate
  • Experimental: HES solution (Tetraspan®)
    Balanced colloid solution
    Intervention: Drug: HES
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective combined cardiac surgery

Exclusion Criteria:

  • Liver failure
  • Kidney failure
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Alexey Schramko, Helsinki University
Helsinki University
B. Braun Melsungen AG
Study Chair: Raili T Suojaranta-Ylinen, MD, PhD Helsinki University Central Hospital
Helsinki University
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP