Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function

Not Applicable

Completed

• Conditions: Renal Impairment
• Interventions: Drug: colloid; Drug: crystalloid

• Registration Number: NCT01729364
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-20
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• elective fast track CABG patients, postoperative

Exclusion Criteria

• hemodynamic instability
• preoperative renal impairment
• major postoperative bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
colloid	colloid	colloidal fluids administration, HES 6% (130/0,4) 7ml/kg under 30 minutes
crystalloid	crystalloid	crystalloid fluid administration, Ringer-acetat 20ml/kg under 30 minutes

Primary Outcome Measures

Name	Time	Method
Change from baseline and differences inbetween groups in glomerular filtration rate, measured at different timepoints	125min after baseline-measures	GFR measured by thermodilution and blood- and urine sampling baseline1 (0min), baseline2 (+30min), timepoint1 (+65min), tp2 (+85min), tp3 (+105min), tp4 (+125min)

Trial Locations

Locations (1)

Sahlgrenska University Hospital/Thoracic Intensive Care; 🇸🇪 Göteborg, Västra Götaland, Sweden