HES and Acute Kidney Injury in Adult Cardiac Surgery

October 29, 2015 updated by: Jean François Brichant, University of Liege

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

697

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults patients undergoing cardiac surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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 ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AKIN SCr
Time Frame: Forty eight hours
Stage of acute kidney injury using the Acute Kidney Injury Network Classification omitting the diuresis criteria.
Forty eight hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AKIN SCr+UO
Time Frame: Forty eight hours
Stage of acute kidney injury using the Acute Kidney Injury Network Classification including the diuresis criteria.
Forty eight hours
Postoperative dialysis
Time Frame: 30 days
Requirement of postoperative renal replacement therapy
30 days
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.
30 days
ICU stay
Time Frame: 30 days
Length of stay at the intensive care unit
30 days
Hospital stay
Time Frame: 30 days
Length of stay at the hospital
30 days
30-day mortality
Time Frame: 30 days
Death in hospital or within 30 days of surgery
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 30, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANES2015002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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