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

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ClinicalTrials.gov Identifier: NCT01511120
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
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Brief Summary:

"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 or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Tetraspan Drug: acetated Ringer's solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of organ edema and improved organ function [ Time Frame: 6-hours postoperatively ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01511120


Locations
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Norway
Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01511120    
Other Study ID Numbers: 2011/498
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: August 2013
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases