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HES and Acute Kidney Injury in Adult Cardiac Surgery

Sponsor
University of Liege (Other)
Overall Status
Completed
CT.gov ID
NCT02445820
Collaborator
(none)
697
Enrollment
8
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
697 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Association Between Hydroxyethyl Starch 130/0.4 and Acute Kidney Injury After Cardiopulmonary Bypass: a Single-center Retrospective Study
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
HES

Balanced HES 130/0.4 used as and pump prime and for intraoperative fluid therapy.

Drug: HES
2500 mL of balanced HES 130/0.4
Other Names:
  • Volulyte®

    		•
    Crystalloid

    Balanced Crystalloid used as a pump prime and for intraoperative fluid therapy.

    Drug: Crystalloid
    2500 mL of balanced crystalloid.
    Other Names:
  • Plasmalyte A ®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AKIN SCr [Forty eight hours]

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

    Secondary Outcome Measures

    1. AKIN SCr+UO [Forty eight hours]

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

    2. Postoperative dialysis [30 days]

      Requirement of postoperative renal replacement therapy

    3. Respiratory complication [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 [30 days]

      Length of stay at the intensive care unit

    5. Hospital stay [30 days]

      Length of stay at the hospital

    6. 30-day mortality [30 days]

      Death in hospital or within 30 days of surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Liege

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jean François Brichant, Professor of Anesthesia and Intensive Care Medicine, University of Liege
    ClinicalTrials.gov Identifier:
    NCT02445820
    Other Study ID Numbers:
    • ANES2015002
    First Posted:
    May 15, 2015
    Last Update Posted:
    Oct 30, 2015
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries
    Plasma-lyte 148

    Study Results

    No Results Posted as of Oct 30, 2015