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Effect of Hydroxyethylstarch 6% 130/0.4 Administration on Renal Function After Cardiac Surgery

NCT ID: NCT02306213

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-04-30

Brief Summary

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Recent studies have shown an increased incidence of renal replacement therapy after the use of Hydroxyethylstarchs (HES) in patients admitted in the intensive care unit. However, studies showing detrimental effects of HES have been conducted in mostly non-surgical subjects. There are very few studies analyzing the effects of HES on renal function after cardiac surgery, a population already at risk of renal dysfunction.

Detailed Description

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Conditions

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Kidney Function Tests

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydroxyethylstarch 6% 130/0.4

These patients have received Hydroxyethylstarch 6% 130/0.4 intraoperatively or postoperatively in addition to standard volume therapy.

Group Type EXPERIMENTAL

Hydroxyethylstarch 6% 130/0.4

Intervention Type DRUG

Use of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit

standard volume therapy

Intervention Type OTHER

No Hydroxyethylstarch 6% 130/0.4

These patients have not received Hydroxyethylstarch 6% 130/0.4 at any time point. Only standard volume therapy has been used.

Group Type ACTIVE_COMPARATOR

standard volume therapy

Intervention Type OTHER

Interventions

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Hydroxyethylstarch 6% 130/0.4

Use of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit

Intervention Type DRUG

standard volume therapy

Intervention Type OTHER

Other Intervention Names

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Any volume therapy has been recorded

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing cardiac surgery

Exclusion Criteria

* Heart transplantation
* Ventricular assist devices
* Patients requiring extracorporeal life support before or after cardiac surgery
* Patients revised for bleeding and/or tamponnade presenting with hemodynamic instability
* Patients in whom the administered volume therapy was not completely available
* Subjects who required renal replacement therapy before surgery
* Trauma patients who were put on cardiopulmonary bypass
* Patients who died intra-operatively or soon after arrival in the intensive care unit in whom no postoperative creatinine measurements were available
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Momeni

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Cliniques Universitaires Saint

Identifier Type: -

Identifier Source: org_study_id