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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 Helsinki University:

Primary Outcome Measures:
  • fluid balance [ Time Frame: 1 postoperative day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective combined cardiac surgery

Exclusion Criteria:

  • Liver failure
  • Kidney failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797589

Contacts
Contact: Alexey A Schramko, MD +358504270610 alexey.schramko@hus.fi

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029
Contact: Raili T Suojaranta-Ylinen, MD, PhD    +358504270608    raili.suojaranta-ylinen@hus.fi   
Principal Investigator: Alexey A Schramko, MD         
Sub-Investigator: Raili T Suojaranta-Ylinen, MD, PhD         
Sub-Investigator: Anne H Kuitunen, MD, PhD         
Principal Investigator: Markku T Salmenperä, Prof, MD         
Sub-Investigator: Tomi T Niemi, MD, PhD         
Sub-Investigator: Sinikka I Kukkonen, MD, PhD         
Sub-Investigator: Peter Raivio         
Sponsors and Collaborators
Helsinki University
B. Braun Melsungen AG
Investigators
Study Chair: Raili T Suojaranta-Ylinen, MD, PhD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Raili Suojaranta-Ylinen / MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT00797589     History of Changes
Other Study ID Numbers: 2008-001225-34
Study First Received: November 24, 2008
Last Updated: June 24, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University:
aorta valve
mitral valve
coronary artery bypass grafting surgery
perfusion
priming

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014