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Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function

NCT ID: NCT01729364

Last Updated: 2015-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-12-31

Brief Summary

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Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen demand.

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Detailed Description

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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.

Conditions

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Renal Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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crystalloid

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

Group Type EXPERIMENTAL

crystalloid

Intervention Type DRUG

colloid

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

Group Type EXPERIMENTAL

colloid

Intervention Type DRUG

Interventions

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crystalloid

Intervention Type DRUG

colloid

Intervention Type DRUG

Other Intervention Names

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Ringer Lactate NaCl Voluven Venofundin Tetraspan

Eligibility Criteria

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Inclusion Criteria

* elective fast track CABG patients, postoperative

Exclusion Criteria

* hemodynamic instability
* preoperative renal impairment
* major postoperative bleeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jenny Skytte Larsson

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jenny Skytte Larsson, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Sven-Erik Ricksten, Professor

Role: STUDY_CHAIR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital/Thoracic Intensive Care

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 26475802 (View on PubMed)

Other Identifiers

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vätskestudien

Identifier Type: -

Identifier Source: org_study_id

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