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Effect of Prime Solution on Fluid Balance After Open Heart Surgery

This study has been completed.
B. Braun Melsungen AG
Information provided by (Responsible Party):
Alexey Schramko, Helsinki University Identifier:
First received: November 24, 2008
Last updated: August 24, 2015
Last verified: August 2015
The use of Tetraspan® as prime solution can reduce fluid extravasation after perfusion versus Ringer acetate. Plasma-adapted HES-solutions produce also less acidosis.

Condition Intervention Phase
Valve Surgery Coronary Artery Bypass Grafting Drug: HES Drug: Ringer lactate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Prime Solution on Fluid Balance After Open Heart Surgery

Resource links provided by NLM:

Further study details as provided by Alexey Schramko, Helsinki University:

Primary Outcome Measures:
  • fluid balance [ Time Frame: 1 postoperative day ]

Enrollment: 35
Study Start Date: January 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ringer lactate
Crystalloid solution
Drug: Ringer lactate
Experimental: HES solution (Tetraspan®)
Balanced colloid solution
Drug: HES
20ml/kg as prime fluid

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elective combined cardiac surgery

Exclusion Criteria:

  • Liver failure
  • Kidney failure
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Please refer to this study by its identifier: NCT00797589

Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University
B. Braun Melsungen AG
Study Chair: Raili T Suojaranta-Ylinen, MD, PhD Helsinki University Central Hospital
  More Information

Responsible Party: Alexey Schramko, MD, PhD, Helsinki University Identifier: NCT00797589     History of Changes
Other Study ID Numbers: 2008-001225-34
Study First Received: November 24, 2008
Last Updated: August 24, 2015

Keywords provided by Alexey Schramko, Helsinki University:
aorta valve
mitral valve
coronary artery bypass grafting surgery

Additional relevant MeSH terms:
Pharmaceutical Solutions processed this record on September 21, 2017