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CompletedNCT02306213Updated Dec 3, 2014

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

An interventional study of Hydroxyethylstarch 6% 130/0.4 and standard volume therapy in Kidney Function Tests, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,564
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Function Tests
03

In context

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients undergoing cardiac surgery

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,564 participants (actual)

Study arms

  • Experimental
    Hydroxyethylstarch 6% 130/0.4

    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

  • Active comparator
    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.

    Other: standard volume therapy

Interventions

  • DrugHydroxyethylstarch 6% 130/0.4

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

    Also known as: Any volume therapy has been recorded

  • Otherstandard volume therapy
06

What researchers measure

Primary outcomes

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

    Time frame: Up to 45 days

Secondary outcomes

  1. Mortality

    Time frame: Up to 45 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02306213
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Momeni (MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain) — Principal investigator
First posted
Dec 3, 2014
Start date
Jan 2011
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Dec 3, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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