CirrhosisNCT05389280
Impact of Acute Kidney Injury on Sarcopenia and Frailty in Patients With Liver Cirrhosis
An observational study of Cirrhosis and Kidney Injury, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The aim of this prospective observational study is to evaluate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cirrhosis, Kidney Injury, Sarcopenia
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2022to 31 Mar 2023
- How long will I take part?
- 3 Months
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver cirrhosis and serum creatinine <1.5 mg/dL
Who may be able to join
- Liver cirrhosis
- aged over 20 years
Who cannot join
- serum creatinine >1.5 mg/dL
- on dialysis
- liver transplant
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kangbuk Samsung Hospital
Seoul
Won Sohn, MD, PhD, 82-2-2001-2557, hand0827@naver.com
About this study
The aim of this prospective observational study is to evaluate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis.
Read the detailed description
The aim of this prospective study is to collect data on patients with liver cirrhosis and to investigate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis. If patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status [RFH-NPT], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. Renal injury was measured using conventional and novel serum biomarkers (serum creatinine, cystatin-C, neutrophil gelatinase-associated lipocalin, kidney injury molecule 1, and interleukin-18. Sarcopenia was evaluated using skeletal muscle index on abdominal computed tomography. Frailty was measured using Liver Frailty Index. The research database will be updated to include data on patients' disease outcomes and follow-up care.
- Conditions
- Cirrhosis, Kidney Injury, Sarcopenia, Frailty
- Medical subject headings
- Fibrosis, Sarcopenia, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Acute kidney injury
an increase in SCr of 0.3 mg/dL (26.4 µmoL/L) in <48 hours, or a 50% increase in SCr from a baseline within ≤3 months
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start23 Mar 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- 80 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Sohn, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389280
- Sponsor's protocol ID
- KBSMCLC2022
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Kidney Injury on Sarcopenia and Frailty in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05389280
- Acronym / sponsor ID
- KBSMCLC2022
- Conditions
- Cirrhosis, Kidney Injury, Sarcopenia, Frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 25 May 2022 (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 aim of this prospective observational study is to evaluate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis.
Detailed description
The aim of this prospective study is to collect data on patients with liver cirrhosis and to investigate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis. If patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status [RFH-NPT], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. Renal injury was measured using conventional and novel serum biomarkers (serum creatinine, cystatin-C, neutrophil gelatinase-associated lipocalin, kidney injury molecule 1, and interleukin-18. Sarcopenia was evaluated using skeletal muscle index on abdominal computed tomography. Frailty was measured using Liver Frailty Index. The research database will be updated to include data on patients' disease outcomes and follow-up care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis and serum creatinine <1.5 mg/dL
Key inclusion criteria (2 listed)
- Liver cirrhosis
- aged over 20 years
Key exclusion criteria (3 listed)
- serum creatinine >1.5 mg/dL
- on dialysis
- liver transplant
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
Number of Participants with Acute kidney injury
Time frame: up to 24 weeks
an increase in SCr of 0.3 mg/dL (26.4 µmoL/L) in <48 hours, or a 50% increase in SCr from a baseline within ≤3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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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.
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 Cirrhosis and Kidney Injury, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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 3 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 25 May 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Acute kidney injury (time frame: up to 24 weeks). 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 25 May 2022.