- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06005896
A Clinical Model for Dialysis Discontinuation in AKI
August 16, 2023 updated by: University of Sao Paulo General Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
124
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
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São Paulo, SP, Brazil, 01246903
- University of Sao Paulo School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Critically ill patients from a large tertiary care hospital receiving kidney replacement therapy due to AKI.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who had kidney replacement therapy interrupted exclusively due to haemodynamic instability, death or decision for palliative care were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success in RRT discontinuation
Time Frame: 7 days
|
To be alive and free from RRT 7 days after interrupting RRT.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
February 1, 2022
Study Completion (Actual)
February 1, 2022
Study Registration Dates
First Submitted
August 16, 2023
First Submitted That Met QC Criteria
August 16, 2023
First Posted (Actual)
August 23, 2023
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 16, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 51678521.0.0000.0068
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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