Renal FailureNGALNCT05161910
ROLE OF URINARY BIOMARKER NEUTROPHIL GELATINASE ASSOCIATED LIPOCALCIN (NGAL) IN EARLY PREDICTION OF AKI IN CIRRHOSIS OF LIVER
An observational study of Renal Failure, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Kidney dysfunction is a complex and common event in patients with liver cirrhosis. Although novel treatments have shown some promising results , acute kidney injury remains a major complication of decompensated liver cirrhosis with high morbidity and mortality rates . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- Biomarkers
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2020to 30 Aug 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120
Who may be able to join
- Cirrhosis diagnosis by combination of clinical, laboratorial, endoscopic and imaging
- Age over 18 years old
- Acute kidney injury (defined by ICA-AKI criteria)
- Agreement to participate in the study
Who cannot join
- Shock/CCF
- Age less than 18yrs •
- Underwent renal replacement therapy within the last 6 week prior to evaluation
- Prior kidney or liver transplantation
- Confirmed pregnancy
- Established CKD
- Congestive cardiac failure
- Patients who have taken diuretics in the last 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urinary Biomarker Neutrophil Gelatinase Associated Lipocalcin (NGAL) in Early Prediction of AKI in Cirrhosis of Liver
Kidney dysfunction is a complex and common event in patients with liver cirrhosis. Although novel treatments have shown some promising results , acute kidney injury remains a major complication of decompensated liver cirrhosis with high morbidity and mortality rates . AKI occurs in up to 19-20% of hospitalized patients with liver cirrhosis and among the most frequent causes are prerenal azotemia (PRA), hepatorenal syndrome and acute tubular necrosis , with prevalence rates estimated around 68%, 25%, and 33%, respectively.
The introduction and widespread use of diagnostic criteria of AKI in the area of cirrhosis has contributed to an increased awareness and earlier detection of AKI. However, some important problems remain. One of the main issues is the differential diagnosis of AKI, particularly between acute tubular necrosis (ATN) and hepatorenal syndrome (HRS-AKI). This is important because treatment is different; renal replacement therapy (RRT) is used for the former, and vasoconstrictors and albumin are used for the latter.
Read the detailed description
Aim of the study:
To determine utility of NGAL in chronic liver disease patients with acute kidney injury.
Objective:
- To compare urine NGAL values in HRS and Non-HRS group.
- To determine optimal cutoff of urine NGAL for early determination of HRS.
Plan of investigation:
All the following investigations will be done at admission for the patients who satisfy the inclusion criteria
Routine blood investigations :
CBP, LFT, PT- INR, RFT urine sodium on day 1 urine spot urine protein creatinine ratio CUE Urine c/s Urine NGAL Serum creatinine will be repeated on Day 3.
- Conditions
- Renal Failure
- Being tested
- Biomarkers
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiomarkersOther
Kidney biomarkers appear to be useful in differential diagnosis between acute tubular necrosis (ATN) and other types of acute kidney injury (AKI) in cirrhosis, particularly hepatorenal syndrome (HRS-AKI).
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare urine Neutrophil Gelatinase Associated lipocalcin values in Hepato renal syndrome and Non-Hepato renal syndrome group.
Kidney biomarkers appear to be useful in differential diagnosis between acute tubular necrosis (ATN) and other types of acute kidney injury (AKI) in cirrhosis, particularly hepatorenal syndrome (HRS-AKI)
Measured: 12 months
Secondary outcomes (1)
. To determine optimal cutoff of urine NGAL for early determination of HRS.
increase in the serum creatinine ≥ 0.3 mg/dl within 48 h or ≥ 50% from baseline value according to ICA(international club ascites) consensus document and /or urinary output ≤ 0.5 ml/kg B.W. ≥6h
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Mar 2020
- Primary completion1 Feb 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Mohan Dr Ramchandani, MBBS MD, Study director, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161910
- Sponsor's protocol ID
- CLD
- Acronym
- NGAL
- Status last verified
- Nov 2021
- First submitted
- 4 Dec 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Biomarker Neutrophil Gelatinase Associated Lipocalcin (NGAL) in Early Prediction of AKI in Cirrhosis of Liver
- ClinicalTrials.gov ID
- NCT05161910
- Acronym / sponsor ID
- NGAL / CLD
- Conditions
- Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 17 Dec 2021 (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.
Kidney dysfunction is a complex and common event in patients with liver cirrhosis. Although novel treatments have shown some promising results , acute kidney injury remains a major complication of decompensated liver cirrhosis with high morbidity and mortality rates . AKI occurs in up to 19-20% of hospitalized patients with liver cirrhosis and among the most frequent causes are prerenal azotemia (PRA), hepatorenal syndrome and acute tubular necrosis , with prevalence rates estimated around 68%, 25%, and 33%, respectively.
The introduction and widespread use of diagnostic criteria of AKI in the area of cirrhosis has contributed to an increased awareness and earlier detection of AKI. However, some important problems remain. One of the main issues is the differential diagnosis of AKI, particularly between acute tubular necrosis (ATN) and hepatorenal syndrome (HRS-AKI). This is important because treatment is different; renal replacement therapy (RRT) is used for the former, and vasoconstrictors and albumin are used for the latter.
Detailed description
Aim of the study:
To determine utility of NGAL in chronic liver disease patients with acute kidney injury.
Objective:
- To compare urine NGAL values in HRS and Non-HRS group.
- To determine optimal cutoff of urine NGAL for early determination of HRS.
Plan of investigation:
All the following investigations will be done at admission for the patients who satisfy the inclusion criteria
Routine blood investigations :
CBP, LFT, PT- INR, RFT urine sodium on day 1 urine spot urine protein creatinine ratio CUE Urine c/s Urine NGAL Serum creatinine will be repeated on Day 3.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120
Key inclusion criteria (4 listed)
- Cirrhosis diagnosis by combination of clinical, laboratorial, endoscopic and imaging
- Age over 18 years old
- Acute kidney injury (defined by ICA-AKI criteria)
- Agreement to participate in the study
Key exclusion criteria (8 listed)
- Shock/CCF
- Age less than 18yrs •
- Underwent renal replacement therapy within the last 6 week prior to evaluation
- Prior kidney or liver transplantation
- Confirmed pregnancy
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 |
|---|---|---|
| BiomarkersKidney biomarkers appear to be useful in differential diagnosis between acute tubular necrosis (ATN) and other types of acute kidney injury (AKI) in cirrhosis, particularly hepatorenal syndrome (HRS-AKI). | Other | – |
Primary outcome
To compare urine Neutrophil Gelatinase Associated lipocalcin values in Hepato renal syndrome and Non-Hepato renal syndrome group.
Time frame: 12 months
Kidney biomarkers appear to be useful in differential diagnosis between acute tubular necrosis (ATN) and other types of acute kidney injury (AKI) in cirrhosis, particularly hepatorenal syndrome (HRS-AKI)
1 secondary outcome
. To determine optimal cutoff of urine NGAL for early determination of HRS.
Time frame: 12 months
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 29 Dec 2021.
- 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.
Mohan Dr Ramchandani, MBBS MD study director
Asian Institute of Gastroenterology, India
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 Failure, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 4 inclusion and 8 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 29 Dec 2021. 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 India. 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?
To compare urine Neutrophil Gelatinase Associated lipocalcin values in Hepato renal syndrome and Non-Hepato renal syndrome group. (time frame: 12 months). 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 29 Dec 2021.