Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function
Colloid vs Crystalloid Infusion Postoperative in CABG Patients Regarding Renal Hemodynamics and Function
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 9, 2012
CompletedFirst Posted
Study publicly available on registry
November 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 22, 2015
May 1, 2015
6.7 years
November 9, 2012
May 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
125min after baseline-measures
Study Arms (2)
crystalloid
EXPERIMENTALcrystalloid fluid administration, Ringer-acetat 20ml/kg under 30 minutes
colloid
EXPERIMENTALcolloidal fluids administration, HES 6% (130/0,4) 7ml/kg under 30 minutes
Interventions
Eligibility Criteria
You may qualify if:
- elective fast track CABG patients, postoperative
You may not qualify if:
- hemodynamic instability
- preoperative renal impairment
- major postoperative bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sahlgrenska University Hospital/Thoracic Intensive Care
Gothenburg, Västra Götaland County, 41345, Sweden
Related Publications (1)
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.
PMID: 26475802DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jenny Skytte Larsson, MD
Sahlgrenska University Hospital
- STUDY CHAIR
Sven-Erik Ricksten, Professor
Sahlgrenska University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 9, 2012
First Posted
November 20, 2012
Study Start
April 1, 2008
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 22, 2015
Record last verified: 2015-05