Back to resultsFluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function
Primary Purpose
Renal Impairment
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
crystalloid
colloid
Sponsored by
About this trial
This is an interventional prevention trial for Renal Impairment focused on measuring elective CABG, renal impairment, GFR, renal blood flow, colloid, crystalloid, thermodilution technique, oxygen supply demand
Eligibility Criteria
Inclusion Criteria:
- elective fast track CABG patients, postoperative
Exclusion Criteria:
- hemodynamic instability
- preoperative renal impairment
- major postoperative bleeding
Sites / Locations
- Sahlgrenska University Hospital/Thoracic Intensive Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
crystalloid
colloid
Arm Description
crystalloid fluid administration, Ringer-acetat 20ml/kg under 30 minutes
colloidal fluids administration, HES 6% (130/0,4) 7ml/kg under 30 minutes
Outcomes
Primary Outcome Measures
Change from baseline and differences inbetween groups in glomerular filtration rate, measured at different timepoints
GFR measured by thermodilution and blood- and urine sampling baseline1 (0min), baseline2 (+30min), timepoint1 (+65min), tp2 (+85min), tp3 (+105min), tp4 (+125min)
Secondary Outcome Measures
Full Information
NCT ID
NCT01729364
First Posted
November 9, 2012
Last Updated
May 20, 2015
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01729364
Brief Title
Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function
Official Title
Colloid vs Crystalloid Infusion Postoperative in CABG Patients Regarding Renal Hemodynamics and Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen demand.
Detailed Description
Due to blood loss and SIRS postoperative hypovolemia is a usual feature after CABG surgery. Substantial controversy persists regarding the best choice of fluid to be used for resuscitation in this setting regarding renal function and oxygen supply-demand matching. In our study we aim to investigate differences in functional renal parameters by dividing patients postoperatively in two groups, substituted either with crystalloid fluid, Ringer-Acetat, 20 ml/kg or colloid, HES 6% (130/0,4) 10 ml/kg under 20 minutes. Central and renal hemodynamics will be measured before (baseline) and after fluid administration by blood sampling and thermodilution in both pulmonary artery catheter and renal vein catheter. Measurement endpoints will mainly consist of central hemodynamics, renal blood flow, GFR and renal oxygen extraction rate which we aim to compare between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
elective CABG, renal impairment, GFR, renal blood flow, colloid, crystalloid, thermodilution technique, oxygen supply demand
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
crystalloid
Arm Type
Experimental
Arm Description
crystalloid fluid administration, Ringer-acetat 20ml/kg under 30 minutes
Arm Title
colloid
Arm Type
Experimental
Arm Description
colloidal fluids administration, HES 6% (130/0,4) 7ml/kg under 30 minutes
Intervention Type
Drug
Intervention Name(s)
crystalloid
Other Intervention Name(s)
Ringer Lactate, NaCl
Intervention Type
Drug
Intervention Name(s)
colloid
Other Intervention Name(s)
Voluven, Venofundin, Tetraspan
Primary Outcome Measure Information:
Title
Change from baseline and differences inbetween groups in glomerular filtration rate, measured at different timepoints
Description
GFR measured by thermodilution and blood- and urine sampling baseline1 (0min), baseline2 (+30min), timepoint1 (+65min), tp2 (+85min), tp3 (+105min), tp4 (+125min)
Time Frame
125min after baseline-measures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective fast track CABG patients, postoperative
Exclusion Criteria:
hemodynamic instability
preoperative renal impairment
major postoperative bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny Skytte Larsson, MD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sven-Erik Ricksten, Professor
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Sahlgrenska University Hospital/Thoracic Intensive Care
City
Göteborg
State/Province
Västra Götaland
ZIP/Postal Code
41345
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26475802
Citation
Skytte Larsson J, Bragadottir G, Krumbholz V, Redfors B, Sellgren J, Ricksten SE. Effects of acute plasma volume expansion on renal perfusion, filtration, and oxygenation after cardiac surgery: a randomized study on crystalloid vs colloid. Br J Anaesth. 2015 Nov;115(5):736-42. doi: 10.1093/bja/aev346.
Results Reference
derived
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Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function
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