Renal Replacement TherapiesNCT06897254
Outcomes of Critically Ill Patients Undergoing RRT- a Registry Based Study.
An observational study of Renal Replacement Therapies and Outcome Assessment, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
Rationale: Acute kidney injury (AKI) requiring renal replacement therapy (RRT) is a frequently occurring entity among critically ill patients. This study aims to determine the outcomes of patients undergoing renal replacement therapy in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Replacement Therapies, Outcome Assessment
- How many people
- 516 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2020to 31 Dec 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: All patients admitted to the ICU requiring renal replacement therapy
Who may be able to join
- Age>18 years
- Admission to the ICU
- All patients undergoing RRT during ICU stay
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Acute Kidney Injury Requiring Renal Replacement Therapy in a Tertiary Level Teaching Hospital in Nepal: a Registry Based Retrospective Study
Rationale: Acute kidney injury (AKI) requiring renal replacement therapy (RRT) is a frequently occurring entity among critically ill patients. This study aims to determine the outcomes of patients undergoing renal replacement therapy in the ICU.
Study Objective: To find the outcomes of patients undergoing RRT in the ICU in terms of mortality and length of ICU stay.
Read more
Design: A registry based, retrospective, descriptive study. Sample size: Convenience sampling of all the patients who require RRT during the ICU stay.
Duration: Retrospective data from three years January 1, 2020 to December 30, 2023.
Place: Intensive care units (ICUs) of the Department of Critical Care Medicine, Tribhuvan University Teaching Hospital (TUTH).
Interventions: Not applicable Expected results: The study will help determine the outcomes of the critically ill patients undergoing RRT in a low middle income country ICU.
- Conditions
- Renal Replacement Therapies, Outcome Assessment
- Keywords
- renal replacement therapy, hemodialysis, intensive care unit, outcomes
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 |
|---|---|---|
| RRT | Patients undergoing renal replacement therapy | |
| NRRT | Patients not undergoing renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Measured: A the end of 3 years
Secondary outcomes (1)
Treatment limitations
Patients who receiving treatment limitation orders (Leave against medical advice, do not resuscitate/do not intubate, withdrawal of treatment orders)
Measured: At the end of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Replacement TherapiesStudies 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
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bipin Karki, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897254
- Sponsor's protocol ID
- 518(6-11)E2-079/080
- Status last verified
- Apr 2025
- First submitted
- 16 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cerda J, Mohan S, Garcia-Garcia G, Jha V, Samavedam S, Gowrishankar S, Bagga A, Chakravarthi R, Mehta R. Acute Kidney Injury Recognition in Low- and Middle-Income Countries. Kidney Int Rep. 2017 Jul;2(4):530-543. doi: 10.1016/j.ekir.2017.04.009. Epub 2017 Apr 25.
PubMed 29034358Andonovic M, Traynor JP, Shaw M, Sim MAB, Mark PB, Puxty KA. Short- and long-term outcomes of intensive care patients with acute kidney disease. EClinicalMedicine. 2022 Feb 12;44:101291. doi: 10.1016/j.eclinm.2022.101291. eCollection 2022 Feb.
PubMed 35198917
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Acute Kidney Injury Requiring Renal Replacement Therapy in a Tertiary Level Teaching Hospital in Nepal: a Registry Based Retrospective Study
- ClinicalTrials.gov ID
- NCT06897254
- Acronym / sponsor ID
- 518(6-11)E2-079/080
- Conditions
- Renal Replacement Therapies, Outcome Assessment
- Keywords
- renal replacement therapy, hemodialysis, intensive care unit, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Mar 2025 (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.
Rationale: Acute kidney injury (AKI) requiring renal replacement therapy (RRT) is a frequently occurring entity among critically ill patients. This study aims to determine the outcomes of patients undergoing renal replacement therapy in the ICU.
Study Objective: To find the outcomes of patients undergoing RRT in the ICU in terms of mortality and length of ICU stay.
Design: A registry based, retrospective, descriptive study. Sample size: Convenience sampling of all the patients who require RRT during the ICU stay.
Duration: Retrospective data from three years January 1, 2020 to December 30, 2023.
Place: Intensive care units (ICUs) of the Department of Critical Care Medicine, Tribhuvan University Teaching Hospital (TUTH).
Interventions: Not applicable Expected results: The study will help determine the outcomes of the critically ill patients undergoing RRT in a low middle income country ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RRT | – | –Patients undergoing renal replacement therapy |
| NRRT | – | –Patients not undergoing renal replacement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the ICU requiring renal replacement therapy
Key inclusion criteria (3 listed)
- Age>18 years
- Admission to the ICU
- All patients undergoing RRT during ICU stay
Key exclusion criteria (1 listed)
- None
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
ICU mortality
Time frame: A the end of 3 years
1 secondary outcome
Treatment limitations
Time frame: At the end of 3 years
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 16 Apr 2025.
- Background: PubMed 29034358Cerda J, Mohan S, Garcia-Garcia G, Jha V, Samavedam S, Gowrishankar S, Bagga A, Chakravarthi R, Mehta R. Acute Kidney Injury Recognition in Low- and Middle-Income Countries. Kidney Int Rep. 2017 Jul;2(4):530-543. doi: 10.1016/j.ekir.2017.04.009. Epub 2017 Apr 25.
- Background: PubMed 35198917Andonovic M, Traynor JP, Shaw M, Sim MAB, Mark PB, Puxty KA. Short- and long-term outcomes of intensive care patients with acute kidney disease. EClinicalMedicine. 2022 Feb 12;44:101291. doi: 10.1016/j.eclinm.2022.101291. eCollection 2022 Feb.
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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 Renal Replacement Therapies and Outcome Assessment, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 3 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 16 Apr 2025. 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 Nepal. 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?
ICU mortality (time frame: A the end of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06897254, which also lists 2 linked publications.
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 16 Apr 2025.