Acute Kidney InjuryNCT03513718
Acute Kidney Injury After Cardiac Surgery on CPB
An observational study of Acute Kidney Injury and Congenital Heart Disease, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The purpose of this retrospective study is to determine the incidence and severity of acute kidney injuries (AKI) after heart surgery on cardiopulmonary bypass (CPB) in the pediatric intensive care unit (PICU) in Lausanne, Switzerland. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Congenital Heart Disease, Surgery
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2017to 5 Sep 2023
- 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 Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Retrospective inclusion of all pediatric patients (0-16 years) admitted in our PICU after cardiac surgery with CPB between January 2014 and December 2016
Who may be able to join
- all pediatric patients (0-16 years) admitted to PICU after cardiac surgery with CPB.
Who cannot join
- Preexisting kidney injury,
- no preoperative creatinine lab value
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Acute Kidney Injury After Cardiac Surgery on Cardiopulmonary Bypass in the Pediatric Intensive Care Unit of Lausanne. A Retrospective Study
The purpose of this retrospective study is to determine the incidence and severity of acute kidney injuries (AKI) after heart surgery on cardiopulmonary bypass (CPB) in the pediatric intensive care unit (PICU) in Lausanne, Switzerland.
Read the detailed description
The investigators will review in a retrospective way, all patients aged between 0 and 16 years, admitted in the PICU after cardiac surgery on CPB from 01.01.2014 to 31.12.2016. They will asses for AKI. The first step is to determine the incidence and severity, the second step is to determine the risk factors for AKI and/or protecting factors.
- Conditions
- Acute Kidney Injury, Congenital Heart Disease, Surgery, CBP, Child, Only
- Keywords
- Acute kidney injury, AKI
- Medical subject headings
- Acute Kidney Injury, Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and severity of an AKI occurring during stay in the PICU
Scoring AKI with pRiffle
Measured: up to 3 month
Secondary outcomes (2)
PICU stay and ventilation time
correlation between AKI and invasive ventilation/duration and PICU stay
Measured: up to 3 month
Persisting AKI after release from PICU according to RIFLE score
After leaving ICU
Measured: more than 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Oct 2017
- Primary completion30 Sep 2022
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perez Maria-Helena, Centre Hospitalier Universitaire Vaudois
- Investigators
- Marie-Hélène Perez, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513718
- Sponsor's protocol ID
- 2017-01542
- Other IDs
- 2017
- Status last verified
- Feb 2024
- First submitted
- 9 Apr 2018
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of patients data
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Acute Kidney Injury After Cardiac Surgery on Cardiopulmonary Bypass in the Pediatric Intensive Care Unit of Lausanne. A Retrospective Study
- ClinicalTrials.gov ID
- NCT03513718
- Acronym / sponsor ID
- 2017-01542
- Conditions
- Acute Kidney Injury, Congenital Heart Disease, Surgery, CBP, Child, Only
- Keywords
- Acute kidney injury, AKI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 1 May 2018 (actual)
- 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.
The purpose of this retrospective study is to determine the incidence and severity of acute kidney injuries (AKI) after heart surgery on cardiopulmonary bypass (CPB) in the pediatric intensive care unit (PICU) in Lausanne, Switzerland.
Detailed description
The investigators will review in a retrospective way, all patients aged between 0 and 16 years, admitted in the PICU after cardiac surgery on CPB from 01.01.2014 to 31.12.2016. They will asses for AKI. The first step is to determine the incidence and severity, the second step is to determine the risk factors for AKI and/or protecting factors.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Retrospective inclusion of all pediatric patients (0-16 years) admitted in our PICU after cardiac surgery with CPB between January 2014 and December 2016
Key inclusion criteria (1 listed)
- all pediatric patients (0-16 years) admitted to PICU after cardiac surgery with CPB.
Key exclusion criteria (2 listed)
- Preexisting kidney injury,
- no preoperative creatinine lab value
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence and severity of an AKI occurring during stay in the PICU
Time frame: up to 3 month
Scoring AKI with pRiffle
2 secondary outcomes
PICU stay and ventilation time
Time frame: up to 3 month
Persisting AKI after release from PICU according to RIFLE score
Time frame: more than 3 month
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 13 Feb 2024.
- Individual participant dataSharing planned: No. No sharing of patients data
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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.
Marie-Hélène Perez, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Congenital Heart Disease, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 2 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Presence and severity of an AKI occurring during stay in the PICU (time frame: up to 3 month). 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 13 Feb 2024.