Effect of Prime Solution on Fluid Balance After Open Heart Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

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.

Condition or disease Intervention/treatment Phase
Valve Surgery Coronary Artery Bypass Grafting Drug: HES Drug: Ringer lactate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ringer lactate
Crystalloid solution
Drug: Ringer lactate
Experimental: HES solution (Tetraspan®)
Balanced colloid solution
Drug: HES
20ml/kg as prime fluid

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Alexey Schramko, MD, PhD, Helsinki University Identifier: NCT00797589     History of Changes
Other Study ID Numbers: 2008-001225-34
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Pharmaceutical Solutions