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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02306213
Enrollment
1564
Registered
2014-12-03
Start date
2011-01-31
Completion date
2013-04-30
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Function Tests

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.

Interventions

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

OTHERstandard volume therapy

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Renal dysfunction based on RIFLE (Risk; Injury; Failure; Loss; End-stage) criteria.Up to 45 days

Secondary

MeasureTime frame
MortalityUp to 45 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026