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Completed

NCT Number: NCT01729364

Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function

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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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital/Thoracic Intensive Care

Gothenburg, Västra Götaland County, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective fast track CABG patients, postoperative

Exclusion criteria

  • hemodynamic instability
  • preoperative renal impairment
  • major postoperative bleeding

Treatment and study plan

Crystalloid

Drug

Other names: Ringer Lactate, NaCl

colloid

Drug

Other names: Voluven, Venofundin, Tetraspan

Primary outcomes

  1. Change from baseline and differences inbetween groups in glomerular filtration rate, measured at different timepoints

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Nov 20, 2012
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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