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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02445820
Other study ID # ANES2015002
Secondary ID
Status Completed
Phase N/A
First received May 5, 2015
Last updated October 29, 2015
Start date November 2014
Est. completion date July 2015

Study information

Verified date October 2015
Source University Hospital of Liege
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 697
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Drug:
HES
2500 mL of balanced HES 130/0.4
Crystalloid
2500 mL of balanced crystalloid.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Liege

Outcome

Type Measure Description Time frame Safety issue
Primary AKIN SCr Stage of acute kidney injury using the Acute Kidney Injury Network Classification omitting the diuresis criteria. Forty eight hours No
Secondary AKIN SCr+UO Stage of acute kidney injury using the Acute Kidney Injury Network Classification including the diuresis criteria. Forty eight hours No
Secondary Postoperative dialysis Requirement of postoperative renal replacement therapy 30 days No
Secondary Respiratory complication Need for reintubation, non-invasive ventilation or prolonged intensive care unit stay as a consequence of atelectasis, pulmonary edema or pneumonia. 30 days No
Secondary ICU stay Length of stay at the intensive care unit 30 days No
Secondary Hospital stay Length of stay at the hospital 30 days No
Secondary 30-day mortality Death in hospital or within 30 days of surgery 30 days No