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
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"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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
|Active Comparator: Tetraspan||
Drug: acetated Ringer's solution
- 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.
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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|
- Patients undergoing CABG,
- EF(ejection fraction) more than 40%
- Reduced EF (less than 40%) EVF less than 30%,
- Estimated GFR less than 60%,
- BMI less than 18 or more than 32
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
|Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus|
|Bergen, Norway, 5021|
|Responsible Party:||Haukeland University Hospital|
|Other Study ID Numbers:||
|First Posted:||January 18, 2012 Key Record Dates|
|Last Update Posted:||May 12, 2015|
|Last Verified:||August 2013|
Coronary Artery Disease
Arterial Occlusive Diseases