Acute Kidney InjuryNCT04012008
Standard Versus Comprehensive Care for Post Acute Kidney Injury
A study testing Comprehensive care in people with Acute Kidney Injury, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The investigators aim to compare between standard versus comprehensive care for post-acute kidney injury who are admitted with acute kidney injury at least stage 2 or receive renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Comprehensive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 16 Jul 2019to 30 Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- Acute kidney injury at least stage 2 OR
- Received renal replacement therapy
Who cannot join
- Post kidney transplantation
- End-stage renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard Versus Comprehensive Care for Post Acute Kidney Injury: A Randomized Controlled Trial
The investigators aim to compare between standard versus comprehensive care for post-acute kidney injury who are admitted with acute kidney injury at least stage 2 or receive renal replacement therapy.
- Conditions
- Acute Kidney Injury
- Being tested
- Comprehensive care, Standard care
- 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.
Comprehensive careOther
- Regular follow-up by nephrologists every 1-3 month
- Multidisciplinary team consisting pharmacists, nurses, and dieticians
Standard careOther
- Regular follow-up by internists every 3 month
- May consult nephrologists case-by-case
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | * Regular follow-up by internists every 3 month
* May consult nephrologists case-by-case Receives: Other: Standard care |
| Comprehensive care | Experimental | * Regular follow-up by nephrologists every 1-3 month
* Multidisciplinary team consisting pharmacists, nurses, and dieticians Receives: Other: Comprehensive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year major adverse kidney events
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start16 Jul 2019
- Primary completion16 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012008
- Sponsor's protocol ID
- IRB.005/62
- Status last verified
- Oct 2022
- First submitted
- 4 Jul 2019
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thanapongsatorn P, Chaikomon K, Lumlertgul N, Yimsangyad K, Leewongworasingh A, Kulvichit W, Sirivongrangson P, Peerapornratana S, Chaijamorn W, Avihingsanon Y, Srisawat N. Comprehensive versus standard care in post-severe acute kidney injury survivors, a randomized controlled trial. Crit Care. 2021 Aug 31;25(1):322. doi: 10.1186/s13054-021-03747-7.
PubMed 34465357
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Comprehensive Care for Post Acute Kidney Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04012008
- Acronym / sponsor ID
- IRB.005/62
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 16 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Jul 2019 (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 investigators aim to compare between standard versus comprehensive care for post-acute kidney injury who are admitted with acute kidney injury at least stage 2 or receive renal replacement therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Standard care* Regular follow-up by internists every 3 month * May consult nephrologists case-by-case |
| Comprehensive care | Experimental | Other: Comprehensive care* Regular follow-up by nephrologists every 1-3 month * Multidisciplinary team consisting pharmacists, nurses, and dieticians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute kidney injury at least stage 2 OR
- Received renal replacement therapy
Key exclusion criteria (2 listed)
- Post kidney transplantation
- End-stage renal disease
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 |
|---|---|---|
| Comprehensive care* Regular follow-up by nephrologists every 1-3 month * Multidisciplinary team consisting pharmacists, nurses, and dieticians | Other | Comprehensive care |
| Standard care* Regular follow-up by internists every 3 month * May consult nephrologists case-by-case | Other | Standard care |
Primary outcome
1 year major adverse kidney events
Time frame: 1-year
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 31 Oct 2022.
- Derived from this study: PubMed 34465357Thanapongsatorn P, Chaikomon K, Lumlertgul N, Yimsangyad K, Leewongworasingh A, Kulvichit W, Sirivongrangson P, Peerapornratana S, Chaijamorn W, Avihingsanon Y, Srisawat N. Comprehensive versus standard care in post-severe acute kidney injury survivors, a randomized controlled trial. Crit Care. 2021 Aug 31;25(1):322. doi: 10.1186/s13054-021-03747-7.
- Individual participant dataSharing planned: No
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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?
A study testing Comprehensive care in people with Acute Kidney Injury, run by Chulalongkorn University at 1 site in Thailand.
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 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 31 Oct 2022. 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 Thailand. 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?
1 year major adverse kidney events (time frame: 1-year). 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 NCT04012008, which also lists 1 linked publication.
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 31 Oct 2022.