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OpenTrials
Completed

NCT Number: NCT02306213

Effect of Hydroxyethylstarch 6% 130/0.4 Administration on Renal Function After Cardiac Surgery

Recent studies have shown an increased incidence of renal replacement therapy after the use of Hydroxyethylstarchs (HES) in patients admitted in the intensive care unit. However, studies showing detrimental effects of HES have been conducted in mostly non-surgical subjects. There are very few studies analyzing the effects of HES on renal function after cardiac surgery, a population already at risk of renal dysfunction.

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Key information

Conditions

Kidney Function Tests

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients undergoing cardiac surgery

Exclusion criteria

  • Heart transplantation
  • Ventricular assist devices
  • Patients requiring extracorporeal life support before or after cardiac surgery
  • Patients revised for bleeding and/or tamponnade presenting with hemodynamic instability
  • Patients in whom the administered volume therapy was not completely available
  • Subjects who required renal replacement therapy before surgery
  • Trauma patients who were put on cardiopulmonary bypass
  • Patients who died intra-operatively or soon after arrival in the intensive care unit in whom no postoperative creatinine measurements were available

Treatment and study plan

Hydroxyethylstarch 6% 130/0.4

Drug

Use of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit

Other names: Any volume therapy has been recorded

standard volume therapy

Other

Primary outcomes

  1. Renal dysfunction based on RIFLE (Risk; Injury; Failure; Loss; End-stage) criteria.

    Time frame: Up to 45 days

Secondary outcomes

  1. Mortality

    Time frame: Up to 45 days

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 3, 2014
Registry last updated
Dec 3, 2014

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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