Acute Kidney Injury After Adult Cardiac SurgeryNCT02445820
HES and Acute Kidney Injury in Adult Cardiac Surgery
An observational study of Acute Kidney Injury After Adult Cardiac Surgery, run by University of Liege.
Trial summary
This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES) 130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury After Adult Cardiac Surgery
- What is being tested?
- HES and Crystalloid
- How many people
- 697 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jul 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients undergoing cardiac surgery
Who may be able to join
- Age ≥ 18 yo
- Having on pump cardiac surgery at CHU of Liège between April 2013 and June 2014
Who cannot join
- Off pump surgery
- Use of Blood or Albumin in the cardiopulmonary bypass priming solution
- Preoperative dialysis
About this study
Official title: The Association Between Hydroxyethyl Starch 130/0.4 and Acute Kidney Injury After Cardiopulmonary Bypass: a Single-center Retrospective Study
This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES) 130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery patients.
- Being tested
- HES, Crystalloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HESDrug
Also called Volulyte®
2500 mL of balanced HES 130/0.4
CrystalloidDrug
Also called Plasmalyte A ®
2500 mL of balanced crystalloid.
| Study group | Role | What they receive |
|---|---|---|
| HES | Balanced HES 130/0.4 used as and pump prime and for intraoperative fluid therapy. Receives: Drug: HES | |
| Crystalloid | Balanced Crystalloid used as a pump prime and for intraoperative fluid therapy. Receives: Drug: Crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKIN SCr
Stage of acute kidney injury using the Acute Kidney Injury Network Classification omitting the diuresis criteria.
Measured: Forty eight hours
Secondary outcomes (6)
AKIN SCr+UO
Stage of acute kidney injury using the Acute Kidney Injury Network Classification including the diuresis criteria.
Measured: Forty eight hours
Postoperative dialysis
Requirement of postoperative renal replacement therapy
Measured: 30 days
Respiratory complication
Need for reintubation, non-invasive ventilation or prolonged intensive care unit stay as a consequence of atelectasis, pulmonary edema or pneumonia.
Measured: 30 days
ICU stay
Length of stay at the intensive care unit
Measured: 30 days
Hospital stay
Length of stay at the hospital
Measured: 30 days
30-day mortality
Death in hospital or within 30 days of surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury After Adult Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445820
- Sponsor's protocol ID
- ANES2015002
- Status last verified
- Oct 2015
- First submitted
- 5 May 2015
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Hydroxyethyl Starch 130/0.4 and Acute Kidney Injury After Cardiopulmonary Bypass: a Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT02445820
- Acronym / sponsor ID
- ANES2015002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 May 2015 (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.
This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES) 130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HES | – | Drug: HESBalanced HES 130/0.4 used as and pump prime and for intraoperative fluid therapy. |
| Crystalloid | – | Drug: CrystalloidBalanced Crystalloid used as a pump prime and for intraoperative fluid therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients undergoing cardiac surgery
Key inclusion criteria (2 listed)
- Age ≥ 18 yo
- Having on pump cardiac surgery at CHU of Liège between April 2013 and June 2014
Key exclusion criteria (3 listed)
- Off pump surgery
- Use of Blood or Albumin in the cardiopulmonary bypass priming solution
- Preoperative dialysis
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 |
|---|---|---|
| HESAlso: Volulyte®2500 mL of balanced HES 130/0.4 | Drug | HES |
| CrystalloidAlso: Plasmalyte A ®2500 mL of balanced crystalloid. | Drug | Crystalloid |
Primary outcome
AKIN SCr
Time frame: Forty eight hours
Stage of acute kidney injury using the Acute Kidney Injury Network Classification omitting the diuresis criteria.
6 secondary outcomes
AKIN SCr+UO
Time frame: Forty eight hours
Postoperative dialysis
Time frame: 30 days
Respiratory complication
Time frame: 30 days
ICU stay
Time frame: 30 days
Hospital stay
Time frame: 30 days
30-day mortality
Time frame: 30 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 30 Oct 2015.
Related trials for Acute Kidney Injury After Adult Cardiac Surgery
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Acute Kidney Injury After Adult Cardiac Surgery, Gastrointestinal Microbiome
RecruitingObservational study
A Monitoring System Based on the Multifactorial Dynamic Perfusion Index to Predict and Prevent the Onset of Postoperative Acute Kidney Injury After Cardiac Surgery, Based on a Dynamic Collection of Hemodynamic and Clinical Parameters During Cardiopulmonary Bypass
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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?
An observational study of Acute Kidney Injury After Adult Cardiac Surgery, run by University of Liege.
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 2 inclusion and 3 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 30 Oct 2015. 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?
AKIN SCr (time frame: Forty eight hours). 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 30 Oct 2015.