Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT01729364

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment	Drug: crystalloid Drug: colloid	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: crystalloid crystalloid fluid administration, Ringer-acetat 20ml/kg under 30 minutes	Drug: crystalloid Other Names: Ringer Lactate NaCl
Experimental: colloid colloidal fluids administration, HES 6% (130/0,4) 7ml/kg under 30 minutes	Drug: colloid Other Names: Voluven Venofundin Tetraspan

Arm

Intervention/Treatment

Experimental: crystalloid

crystalloid fluid administration, Ringer-acetat 20ml/kg under 30 minutes

Drug: crystalloid

Other Names:

Ringer Lactate

NaCl

Experimental: colloid

colloidal fluids administration, HES 6% (130/0,4) 7ml/kg under 30 minutes

Drug: colloid

Other Names:

Voluven

Venofundin

Tetraspan

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

elective fast track CABG patients, postoperative

Exclusion Criteria:

hemodynamic instability
preoperative renal impairment
major postoperative bleeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital/Thoracic Intensive Care	Göteborg	Västra Götaland	Sweden	41345

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

Principal Investigator: Jenny Skytte Larsson, MD, Sahlgrenska University Hospital, Sweden
Study Chair: Sven-Erik Ricksten, Professor, Sahlgrenska University Hospital, Sweden