NCT02445820

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
697

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

8 months

First QC Date

May 5, 2015

Last Update Submit

October 29, 2015

Conditions

Acute Kidney Injury After Adult Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • AKIN SCr

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

    Forty eight hours

Secondary Outcomes (6)

  • AKIN SCr+UO

    Forty eight hours

  • Postoperative dialysis

    30 days

  • Respiratory complication

    30 days

  • ICU stay

    30 days

  • Hospital stay

    30 days

  • +1 more secondary outcomes

Study Arms (2)

HES

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

Drug: HES

Crystalloid

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

Drug: Crystalloid

Interventions

HESDRUG

2500 mL of balanced HES 130/0.4

Also known as: Volulyte®
HES
CrystalloidDRUG

2500 mL of balanced crystalloid.

Also known as: Plasmalyte A ®
Crystalloid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults patients undergoing cardiac surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Crystalloid SolutionsPlasmalyte A

Intervention Hierarchy (Ancestors)

Isotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and Intensive Care Medicine

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 15, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 30, 2015

Record last verified: 2015-10