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

This study has been completed.
Information provided by (Responsible Party):
Haukeland University Hospital Identifier:
First received: December 7, 2011
Last updated: May 11, 2015
Last verified: August 2013

"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

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
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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


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

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
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Please refer to this study by its identifier: NCT01511120

Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital Identifier: NCT01511120     History of Changes
Other Study ID Numbers: 2011/498
Study First Received: December 7, 2011
Last Updated: May 11, 2015
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on October 09, 2015