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Completed

NCT Number: NCT02445820

HES and Acute Kidney Injury in Adult Cardiac Surgery

This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES) 130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery patients.

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Key information

Conditions

Acute Kidney Injury After Adult Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 yo
  • Having on pump cardiac surgery at CHU of Liège between April 2013 and June 2014

Exclusion criteria

  • Off pump surgery
  • Use of Blood or Albumin in the cardiopulmonary bypass priming solution
  • Preoperative dialysis

Treatment and study plan

HES

Drug

2500 mL of balanced HES 130/0.4

Other names: Volulyte®

Crystalloid

Drug

2500 mL of balanced crystalloid.

Other names: Plasmalyte A ®

Primary outcomes

  1. AKIN SCr

    Time frame: Forty eight hours

    Stage of acute kidney injury using the Acute Kidney Injury Network Classification omitting the diuresis criteria.

Secondary outcomes

  1. AKIN SCr+UO

    Time frame: Forty eight hours

    Stage of acute kidney injury using the Acute Kidney Injury Network Classification including the diuresis criteria.

  2. Postoperative dialysis

    Time frame: 30 days

    Requirement of postoperative renal replacement therapy

  3. Respiratory complication

    Time frame: 30 days

    Need for reintubation, non-invasive ventilation or prolonged intensive care unit stay as a consequence of atelectasis, pulmonary edema or pneumonia.

  4. ICU stay

    Time frame: 30 days

    Length of stay at the intensive care unit

  5. Hospital stay

    Time frame: 30 days

    Length of stay at the hospital

  6. 30-day mortality

    Time frame: 30 days

    Death in hospital or within 30 days of surgery

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

The Association Between Hydroxyethyl Starch 130/0.4 and Acute Kidney Injury After Cardiopulmonary Bypass: a Single-center Retrospective Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 15, 2015
Registry last updated
Oct 30, 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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