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The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols

This study is currently recruiting participants.
Verified January 2012 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01511120
First received: December 7, 2011
Last updated: September 7, 2012
Last verified: January 2012
History of Changes
  Purpose

"The impact on fluid loading after cardiac surgery by use of two different priming solution"

Fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been reported to impair both systolic and diastolic function. An association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients.

The investigators have experience with the use of both colloides and combination fluids (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study the investigators used colloides as an additive to the CPB-prime. The investigators observed reduced fluid leakage and less total tissue water in several organs.

The planned study includes patients scheduled for coronary artery bypass, and who have no co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated Ringer`s solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.


Condition Intervention Phase
Coronary Heart Disease
 Drug: Tetraspan
Drug: acetated Ringer`s solution
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Ringer`s Acetat Versus Balanced Hydroxyethyl-starch as Primesolution in the Heart-lung Maschine During Cardio-pulmonary-bypass. Postoperatively Fluid Balance and Cardiac Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Reduction of organ edema and improved organ function [ Time Frame: 6-hours postoperatively ] [ Designated as safety issue: No ]
    As a target of effect the investigators have chosen to study improvements for organ function.Indexed values for cardiac output(CI) measured by the PICCO system will be a parameter for heart function, andf lung function will be measured by EVLWI(extravascular lungwater index).paO2/FiO2-ratio and time spent in respirator.Additionally a strict account for fluid balance will be kept.


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tetraspan Drug: Tetraspan
Other Names:
  • Tetraspan® (HES 130/0,42 , 6%),
  • B. Braun Medical AS
  • Kjernåsveien 13 B
  • 3142 Vestskogen
Drug: acetated Ringer`s solution

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing CABG,
  • EF(ejection fraction) more than 40%

Exclusion Criteria:

  • Reduced EF (less than 40%) EVF less than 30%,
  • Estimated GFR less than 60%,
  • BMI less than 18 or more than 32
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511120

Locations
Norway
Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus Recruiting
Bergen, Norway, 5021
Contact: Venny Lise Kvalheim, PhD     0047 55976713     vkva@helse-bergen.no    
Contact: Marit Farstad, dr.med.     0047 55976869     fars@helse-bergen.no    
Principal Investigator: Venny Lise Kvalheim, PhD            
Sponsors and Collaborators
Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01511120     History of Changes
Other Study ID Numbers: 2011/498
Study First Received: December 7, 2011
Last Updated: September 7, 2012
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013