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

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Tetraspan
acetated Ringer's solution
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Heart Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Tetraspan

Arm Description

Outcomes

Primary Outcome Measures

Reduction of organ edema and improved organ function
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.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2011
Last Updated
May 11, 2015
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01511120
Brief Title
The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tetraspan
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tetraspan
Other Intervention Name(s)
Tetraspan® (HES 130/0,42 , 6%),, B. Braun Medical AS, Kjernåsveien 13 B, 3142 Vestskogen
Intervention Type
Drug
Intervention Name(s)
acetated Ringer's solution
Primary Outcome Measure Information:
Title
Reduction of organ edema and improved organ function
Description
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.
Time Frame
6-hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
29199540
Citation
Svendsen OS, Farstad M, Mongstad A, Haaverstad R, Husby P, Kvalheim VL. Is the use of hydroxyethyl starch as priming solution during cardiac surgery advisable? A randomized, single-center trial. Perfusion. 2018 Sep;33(6):483-489. doi: 10.1177/0267659117746235. Epub 2017 Dec 4.
Results Reference
derived

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

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