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NCT01729364 Clinical Trial

Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function

Renal Impairment Clinical Trial

Official title:
Colloid vs Crystalloid Infusion Postoperative in CABG Patients Regarding Renal Hemodynamics and Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01729364
Other study ID # vätskestudien
Secondary ID
Status Completed
Phase N/A
First received November 9, 2012
Last updated May 20, 2015
Start date April 2008
Est. completion date December 2014

Study information
Verified date May 2015
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority Sweden: Swedish Research Council
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- elective fast track CABG patients, postoperative

Exclusion Criteria:

- hemodynamic instability

- preoperative renal impairment

- major postoperative bleeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• crystalloid

• colloid

Locations
Country Name City State
Sweden Sahlgrenska University Hospital/Thoracic Intensive Care Göteborg Västra Götaland

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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