Acute Kidney InjuryNCT04525625
Risk Factors for Acute Kidney Injury in Critically Ill Patients With Acute-on-Chronic Liver Failure
An observational study of Acute Kidney Injury and Acute-On-Chronic Liver Failure, run by Institutul Clinic Fundeni at 1 site in Romania.
Trial summary
Acute kidney injury (AKI) is one of the most important factors associated with increased mortality in patients with acute-on-chronic liver failure (AoCLF). Early identification and treatment of this subgroup of patients may improve survival and decrease ICU length of stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Acute-On-Chronic Liver Failure
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- 1 Feb 2021to 31 Dec 2024
- 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 consecutive patients admitted to a general ICU for ACLF who fall into the inclusion and exclusion criteria. Standard treatment will be applied to all patients and no supplemental intervention is required for the present study.
Who may be able to join
- patients admitted to the ICU for acute-on-chronic liver failure
Who cannot join
- pre-existing renal disease
- urine output<200 mL/day
- death within the first 24 hours after ICU admission
- emergency liver transplantation within the follow-up period (28 days)
Trial locations and contacts
1 site in 1 country.
Mihai Popescu, Assoc Prof contact
Romania1 site, 1 recruiting
- Recruiting
Popescu Mihai
Bucharest, 022328
Popescu Mihai, MD PhD, 0040751075995, lcf4ever@yahoo.com
About this study
Acute kidney injury (AKI) is one of the most important factors associated with increased mortality in patients with acute-on-chronic liver failure (AoCLF). Early identification and treatment of this subgroup of patients may improve survival and decrease ICU length of stay. As kidney ischemia is one of the main mechanisms responsible for AKI in AoCLF, an increase in urinary to arterial partial pressure of oxygen may help in the early diagnosis of renal failure. For this arterial and urinary oxygen pressure will be measured at ICU admission, on day 1 and day 3 of ICU stay. Diagnosis of AKI within the first 28 days after ICU admission will be recorded
- Medical subject headings
- Acute Kidney Injury, Acute-On-Chronic Liver Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI
incidence (%) of AKI in patients with AoCLF as defined by Acute Kidney Injury Network guidelines
Measured: 28 days after ICU admission
Secondary outcomes (2)
arterial to urinary oxygen gradient
mathematical difference in oxygen partial pressure between arterial blood and urine (mmHg) in patients with AKI compared to patients without AKI
Measured: ICU admission, ICU day 1 and ICU dy 3
mortality
28-day mortality
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Feb 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institutul Clinic Fundeni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Popescu Mihai, Institutul Clinic Fundeni
- Investigators
- Dana Tomescu, Prof, Study chair, Fundeni Clinical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525625
- Sponsor's protocol ID
- AKI-ACLF
- Status last verified
- Feb 2023
- First submitted
- 21 Aug 2020
- Last updated
- 15 Feb 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 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Acute Kidney Injury in Critically Ill Patients With Acute-on-Chronic Liver Failure
- ClinicalTrials.gov ID
- NCT04525625
- Acronym / sponsor ID
- AKI-ACLF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institutul Clinic FundeniUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Aug 2020 (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.
Acute kidney injury (AKI) is one of the most important factors associated with increased mortality in patients with acute-on-chronic liver failure (AoCLF). Early identification and treatment of this subgroup of patients may improve survival and decrease ICU length of stay. As kidney ischemia is one of the main mechanisms responsible for AKI in AoCLF, an increase in urinary to arterial partial pressure of oxygen may help in the early diagnosis of renal failure. For this arterial and urinary oxygen pressure will be measured at ICU admission, on day 1 and day 3 of ICU stay. Diagnosis of AKI within the first 28 days after ICU admission will be recorded
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted to a general ICU for ACLF who fall into the inclusion and exclusion criteria. Standard treatment will be applied to all patients and no supplemental intervention is required for the present study.
Key inclusion criteria (1 listed)
- patients admitted to the ICU for acute-on-chronic liver failure
Key exclusion criteria (4 listed)
- pre-existing renal disease
- urine output<200 mL/day
- death within the first 24 hours after ICU admission
- emergency liver transplantation within the follow-up period (28 days)
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
AKI
Time frame: 28 days after ICU admission
incidence (%) of AKI in patients with AoCLF as defined by Acute Kidney Injury Network guidelines
2 secondary outcomes
arterial to urinary oxygen gradient
Time frame: ICU admission, ICU day 1 and ICU dy 3
mortality
Time frame: 28-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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.
Mihai Popescu, Assoc Prof contact
Dana Tomescu, Prof study chair
Fundeni Clinical Institute
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 Acute-On-Chronic Liver Failure, run by Institutul Clinic Fundeni at 1 site in Romania.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Feb 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 Romania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Tomescu, Prof (0040722300288, danatomescu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKI (time frame: 28 days after ICU admission). 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 15 Feb 2023.