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

Tracking Information
First Received Date ^ICMJE	December 7, 2011
Last Updated Date	September 7, 2012
Start Date ^ICMJE	November 2011
Estimated Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 17, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01511120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols
Official Title ^ICMJE	Ringer`s Acetat Versus Balanced Hydroxyethyl-starch as Primesolution in the Heart-lung Maschine During Cardio-pulmonary-bypass. Postoperatively Fluid Balance and Cardiac Function
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	Coronary Heart Disease
Intervention ^ICMJE	Drug: Tetraspan Other Names: Tetraspan® (HES 130/0,42 , 6%), B. Braun Medical AS Kjernåsveien 13 B 3142 Vestskogen Drug: acetated Ringer`s solution
Study Arm (s)	Active Comparator: Tetraspan Interventions: Drug: Tetraspan Drug: acetated Ringer`s solution
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	November 2012
Estimated Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT01511120
Other Study ID Numbers ^ICMJE	2011/498
Has Data Monitoring Committee	Yes
Responsible Party	Haukeland University Hospital
Study Sponsor ^ICMJE	Haukeland University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Haukeland University Hospital
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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