Acute Renal FailureNCT06005896
A Clinical Model for Dialysis Discontinuation in AKI
An observational study of Acute Renal Failure and Acute Kidney Injury, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
A retrospective study evaluating AKI patients in whom RRT was interrupted for at least 48 hours. Patients who were still RRT-independent 7 days after initial RRT cessation were included in the "Success" group, as opposed to the "Failure" group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure, Acute Kidney Injury
- How many people
- 124 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2020to 1 Feb 2022
- 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: Critically ill patients from a large tertiary care hospital receiving kidney replacement therapy due to AKI.
Who may be able to join
- All patients receiving kidney replacement therapy due to AKI from October 2020 to February 2022 were considered for inclusion in the study. Patients who managed to remain at least 48 consecutive hours without receiving kidney replacement therapy prescription were included.
Who cannot join
- Patients who had kidney replacement therapy interrupted exclusively due to haemodynamic instability, death or decision for palliative care were excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo School of Medicine
São Paulo, São Paulo, 01246903
About this study
Official title: A Clinical Model to Predict Successful Renal Replacement Therapy (RRT) Discontinuation in Patients With Acute Kidney Injury (AKI)
A retrospective study evaluating AKI patients in whom RRT was interrupted for at least 48 hours. Patients who were still RRT-independent 7 days after initial RRT cessation were included in the "Success" group, as opposed to the "Failure" group. Baseline characteristics and variables at the time of RRT interruption were collected. Multivariable analysis was performed and a model was generated to evaluate the prediction of success.
- Conditions
- Acute Renal Failure, Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Success | Patients who were alive and free from RRT 7 days after interrupting RRT. | |
| Failure | Patients who were not alive or who needed to dialyse again after interrupting RRT for at least 48h. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in RRT discontinuation
To be alive and free from RRT 7 days after interrupting RRT.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Oct 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005896
- Sponsor's protocol ID
- 51678521.0.0000.0068
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Model to Predict Successful Renal Replacement Therapy (RRT) Discontinuation in Patients With Acute Kidney Injury (AKI)
- ClinicalTrials.gov ID
- NCT06005896
- Acronym / sponsor ID
- 51678521.0.0000.0068
- Conditions
- Acute Renal Failure, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 23 Aug 2023 (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.
A retrospective study evaluating AKI patients in whom RRT was interrupted for at least 48 hours. Patients who were still RRT-independent 7 days after initial RRT cessation were included in the "Success" group, as opposed to the "Failure" group. Baseline characteristics and variables at the time of RRT interruption were collected. Multivariable analysis was performed and a model was generated to evaluate the prediction of success.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Success | – | –Patients who were alive and free from RRT 7 days after interrupting RRT. |
| Failure | – | –Patients who were not alive or who needed to dialyse again after interrupting RRT for at least 48h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients from a large tertiary care hospital receiving kidney replacement therapy due to AKI.
Key inclusion criteria (1 listed)
- All patients receiving kidney replacement therapy due to AKI from October 2020 to February 2022 were considered for inclusion in the study. Patients who managed to remain at least 48 consecutive hours without receiving kidney replacement therapy prescription were included.
Key exclusion criteria (1 listed)
- Patients who had kidney replacement therapy interrupted exclusively due to haemodynamic instability, death or decision for palliative care were excluded.
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
Success in RRT discontinuation
Time frame: 7 days
To be alive and free from RRT 7 days after interrupting RRT.
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 23 Aug 2023.
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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.
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 Renal Failure and Acute Kidney Injury, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 1 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 23 Aug 2023. 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 Brazil. 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?
Success in RRT discontinuation (time frame: 7 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 23 Aug 2023.