Kidney Function TestsNCT02306213
Effect of Hydroxyethylstarch 6% 130/0.4 Administration on Renal Function After Cardiac Surgery
A study testing Hydroxyethylstarch 6% 130/0.4 and standard volume therapy in people with Kidney Function Tests, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Function Tests
- What is being tested?
- Hydroxyethylstarch 6% 130/0.4 and standard volume therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,564 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing cardiac surgery
Who cannot join
- 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
About this study
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
- Being tested
- Hydroxyethylstarch 6% 130/0.4, standard volume therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethylstarch 6% 130/0.4Drug
Also called Any volume therapy has been recorded
Use of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit
standard volume therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyethylstarch 6% 130/0.4 | Experimental | These patients have received Hydroxyethylstarch 6% 130/0.4 intraoperatively or postoperatively in addition to standard volume therapy. Receives: 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. Receives: Other: standard volume therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal dysfunction based on RIFLE (Risk; Injury; Failure; Loss; End-stage) criteria.
Measured: Up to 45 days
Secondary outcomes (1)
Mortality
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJan 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Function TestsStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,564 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Momeni, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306213
- Sponsor's protocol ID
- Cliniques Universitaires Saint
- Status last verified
- Nov 2014
- First submitted
- 20 Nov 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydroxyethylstarch 6% 130/0.4 Administration on Renal Function After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02306213
- Acronym / sponsor ID
- Cliniques Universitaires Saint
- Conditions
- Kidney Function Tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,564 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxyethylstarch 6% 130/0.4 | Experimental | Drug: Hydroxyethylstarch 6% 130/0.4, Other: standard volume therapyThese patients have received Hydroxyethylstarch 6% 130/0.4 intraoperatively or postoperatively in addition to standard volume therapy. |
| No Hydroxyethylstarch 6% 130/0.4 | Active comparator | Other: standard volume therapyThese patients have not received Hydroxyethylstarch 6% 130/0.4 at any time point. Only standard volume therapy has been used. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing cardiac surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyethylstarch 6% 130/0.4Also: Any volume therapy has been recordedUse of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit | Drug | Hydroxyethylstarch 6% 130/0.4 |
| standard volume therapy | Other | Hydroxyethylstarch 6% 130/0.4, No Hydroxyethylstarch 6% 130/0.4 |
Primary outcome
Renal dysfunction based on RIFLE (Risk; Injury; Failure; Loss; End-stage) criteria.
Time frame: Up to 45 days
1 secondary outcome
Mortality
Time frame: Up to 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyethylstarch 6% 130/0.4 and standard volume therapy in people with Kidney Function Tests, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal dysfunction based on RIFLE (Risk; Injury; Failure; Loss; End-stage) criteria. (time frame: Up to 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.