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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. (see Contacts and Locations)
Verified August 2013 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01511120
First received: December 7, 2011
Last updated: August 28, 2013
Last verified: August 2013
  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:


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 2013
Estimated Primary Completion Date: November 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

  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
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: 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: August 28, 2013
Health Authority: Norway: Regional Ethics Commitee

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

ClinicalTrials.gov processed this record on November 27, 2014