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

NCT02306213 | Completed

• 1 other identifier: Cliniques Universitaires Saint
• Study Type: interventional
• Target: 1,564
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Kidney Function Tests

Outcome Measures

Primary Outcomes (1)

• Renal dysfunction based on RIFLE (Risk; Injury; Failure; Loss; End-stage) criteria.

  Up to 45 days

Secondary Outcomes (1)

• Mortality

  Up to 45 days

Study Arms (2)

Hydroxyethylstarch 6% 130/0.4

EXPERIMENTAL

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

Drug: Hydroxyethylstarch 6% 130/0.4; Other: standard volume therapy

No Hydroxyethylstarch 6% 130/0.4

ACTIVE COMPARATOR

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

Other: standard volume therapy

Interventions

Hydroxyethylstarch 6% 130/0.4 DRUG

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

Also known as: Any volume therapy has been recorded

Hydroxyethylstarch 6% 130/0.4

standard volume therapy OTHER

Hydroxyethylstarch 6% 130/0.4; No Hydroxyethylstarch 6% 130/0.4

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: December 3, 2014
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 3, 2014

Record last verified: 2014-11