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Effect of Prime Solution on Fluid Balance After Open Heart Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2009 by Helsinki University
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00797589
First received: November 24, 2008
Last updated: June 24, 2011
Last verified: February 2009

November 24, 2008
June 24, 2011
January 2009
December 2013   (final data collection date for primary outcome measure)
fluid balance [ Time Frame: 1 postoperative day ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00797589 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective combined cardiac surgery

Exclusion Criteria:

  • Liver failure
  • Kidney failure
Both
18 Years and older
No
Contact: Alexey A Schramko, MD +358504270610 alexey.schramko@hus.fi
Finland
 
NCT00797589
2008-001225-34
No
Raili Suojaranta-Ylinen / MD, PhD, Helsinki University Central Hospital
Helsinki University
B. Braun Melsungen AG
Study Chair: Raili T Suojaranta-Ylinen, MD, PhD Helsinki University Central Hospital
Helsinki University
February 2009

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