Acute Kidney InjuryNCT02049125
Study of Accuracy of NGAL, a Renal Injury Biomarker, in Patients With Cirrhosis
An observational study of Acute Kidney Injury and Hepatorenal Syndrome, run by University of Sao Paulo at 4 sites in Brazil.
Trial summary
The purpose of this study is to test the accuracy of urinary neutrophil-gelatinase associated lipocalin (NGAL) and other biomarkers (plasma renin, norepinephrine) to predict acute kidney injury (AKI) development in patients with cirrhosis and bacterial infection and to predict response to AKI treatment with albumin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Hepatorenal Syndrome
- How many people
- 300 participants
- Where
- 4 sitesBrazil
- Study dates
- Jun 2013to Mar 2018
- 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: We will include cirrhotic patients admitted to hospitals participating centers with AKI and/or bacterial infection.
Who may be able to join
- Cirrhosis diagnosis by liver biopsy or combination of clinical, laboratorial, endoscopic and imagenological data;
- Presence of ascites and/or hepatic hydrothorax;
- Age over 18 years old;
- Diagnosis of bacterial infection (including spontaneous bacterial peritonitis and others) with or without acute kidney injury (defined as a serum creatinine above 1.5mg/dL at admission) or acute kidney injury without bacterial infection;
- Agreement to participate in the study, registered by informed consent;
Who cannot join
- Serious comorbidities (functional class IV heart failure, O2 dependent chronic obstructive pulmonary disease, advanced cancer);
- Shock, as defined by American College of Chest Physicians;
- Chronic kidney disease with serum creatinine persistently above 1.5mg/dL in the previous 6 months and/or with sonographic findings of chronic nephropathy;
- Intrinsic nephropathy with hematuria over 50 red cells/high power field and dysmorphic erythrocyte and/or proteinuria over 500mg/24h;
- Use of nephrotoxic drugs in the previous 30 days;
- Dialysis prior to study inclusion;
- Previous solid organ transplantation.
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites, 4 recruiting
- Not yet recruiting
University of Campinas
Campinas, São Paulo, 13083-887
Daniel FC Mazo, PhD
danielmazo@yahoo.com.br
- Recruiting
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035-903
Mario RA Silva, Assoc. Prof., marioreis@live.com
Mario RA Silva, Assoc. Prof.
- Recruiting
University of Sao Paulo
São Paulo, São Paulo, 05403-010
Rafael O Ximenes, MD, +55011 2661-3338, rximenes@gmail.com
Alberto Q Farias, Assoc. Prof.
- Not yet recruiting
Federal University of Espirito Santo
Vitória, Espírito Santo, 29075-910
Luciana L Goncalves, Ph. D., lucianalofego@terra.com.br
Luciana L Goncalves, Ph. D.
About this study
Official title: Urinary Biomarker NGAL in Decompensated Cirrhosis: Early Prediction of AKI and of Treatment Response
The purpose of this study is to test the accuracy of urinary neutrophil-gelatinase associated lipocalin (NGAL) and other biomarkers (plasma renin, norepinephrine) to predict acute kidney injury (AKI) development in patients with cirrhosis and bacterial infection and to predict response to AKI treatment with albumin and albumin with terlipressin in patients with suspected hepatorenal syndrome.
- Conditions
- Acute Kidney Injury, Hepatorenal Syndrome
- Keywords
- NGAL, Acute kidney injury, Cirrhosis, Hepatorenal syndrome
- Medical subject headings
- Acute Kidney Injury, Hepatorenal Syndrome, Fibrosis
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 |
|---|---|---|
| No AKI | Patients with cirrhosis admitted to hospital with bacterial infection with initial serum creatinine below 1.5mg/dL. | |
| AKI and Infection | Patients with cirrhosis admitted to hospital with bacterial infection and initial serum creatinine above 1.5mg/dL. | |
| AKI with No Infection | Patients with cirrhosis admitted to hospital with initial serum creatinine above 1.5mg/dL without bacterial infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of NGAL to predict no response to albumin expansion
We will build a receiver-operating curve and calculate the area under the curve to determine the accuracy of NGAL to predict no response to albumin expansion. No response will be defined as an absence of a drop of serum creatinine to a final value below 1.5mg/dL in the day after the end of albumin expansion. Albumin will be administrated as International Ascites Club recommendations, i.e. in the dose of 1g/kg/day for 2 days in patients with suspected hepatorenal syndrome.
Measured: One day after albumin expansion (day 3)
Secondary outcomes (5)
Accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment
We will test the accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment. No response to treatment will be defined as a final value of serum creatinine above 1.5mg/dL after the end of treatment with terlipressin plus albumin. The treatment will be conducted according to International Ascites Club recommendations.
Measured: Treatment period (maximum of 14 days)
Accuracy of urinary NGAL and other biomarkers to predict development and progression of acute kidney injury (AKI) in patients with bacterial infection
We will test the accuracy of urinary NGAL and other biomarkers to predict AKI development and progression during antibiotic therapy and during hospital stay in patients with bacterial infection. AKI will be defined by ICA-AKI criteria.
Measured: During antibiotic therapy and during hospital stay
Predictors of mortality
We will test clinical and laboratorial data relationship with in-hospital, 30 days and 90 days mortality in a univariate analysis. Associated variables will be tested in a multivariate analysis.
Measured: In-hospital, 30 days and 90 days
Urinary NGAL as a predictor of adverse events of AKI treatment in cirrhosis
We will build a receiver-operating curve and calculate the area under the curve to determine the accuracy of urinary NGAL to predict adverse events during AKI treatment with albumin alone or in combination with terlipressin. We will also calculate the best cut-off value based on the receiver-operating curve.
Measured: During treatment period
Accuracy of other biomarkers to predict no response to albumin expansion
We will test the accuracy of other biomarkers to predict no response to albumin expansion. No response will be defined as an absence of a drop of serum creatinine to a final value below 1.5mg/dL in the day after the end of albumin expansion. Albumin will be administrated as International Ascites Club recommendations, i.e. in the dose of 1g/kg/day for 2 days in patients with suspected hepatorenal syndrome.
Measured: One day after albumin expansion (day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (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.
- More trials run by University of Sao PauloThe 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Federal University of Espirito Santo, Hospital de Base, University of Campinas, Brazil
- Responsible party
- Principal investigator, Alberto Queiroz Farias, University of Sao Paulo
- Investigators
- Alberto Q Farias, Associate professor, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049125
- Sponsor's protocol ID
- NGAL01
- Status last verified
- Oct 2016
- First submitted
- 27 Jan 2014
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Biomarker NGAL in Decompensated Cirrhosis: Early Prediction of AKI and of Treatment Response
- ClinicalTrials.gov ID
- NCT02049125
- Acronym / sponsor ID
- NGAL01
- Conditions
- Acute Kidney Injury, Hepatorenal Syndrome
- Keywords
- NGAL, Acute kidney injury, Cirrhosis, Hepatorenal syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Federal University of Espirito Santo, Hospital de Base, University of Campinas, Brazil
- Study start
- Jun 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 29 Jan 2014 (estimated)
- 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 purpose of this study is to test the accuracy of urinary neutrophil-gelatinase associated lipocalin (NGAL) and other biomarkers (plasma renin, norepinephrine) to predict acute kidney injury (AKI) development in patients with cirrhosis and bacterial infection and to predict response to AKI treatment with albumin and albumin with terlipressin in patients with suspected hepatorenal syndrome.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No AKI | – | –Patients with cirrhosis admitted to hospital with bacterial infection with initial serum creatinine below 1.5mg/dL. |
| AKI and Infection | – | –Patients with cirrhosis admitted to hospital with bacterial infection and initial serum creatinine above 1.5mg/dL. |
| AKI with No Infection | – | –Patients with cirrhosis admitted to hospital with initial serum creatinine above 1.5mg/dL without bacterial infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will include cirrhotic patients admitted to hospitals participating centers with AKI and/or bacterial infection.
Key inclusion criteria (5 listed)
- Cirrhosis diagnosis by liver biopsy or combination of clinical, laboratorial, endoscopic and imagenological data;
- Presence of ascites and/or hepatic hydrothorax;
- Age over 18 years old;
- Diagnosis of bacterial infection (including spontaneous bacterial peritonitis and others) with or without acute kidney injury (defined as a serum creatinine above 1.5mg/dL at admission) or acute kidney injury without bacterial infection;
- Agreement to participate in the study, registered by informed consent;
Key exclusion criteria (7 listed)
- Serious comorbidities (functional class IV heart failure, O2 dependent chronic obstructive pulmonary disease, advanced cancer);
- Shock, as defined by American College of Chest Physicians;
- Chronic kidney disease with serum creatinine persistently above 1.5mg/dL in the previous 6 months and/or with sonographic findings of chronic nephropathy;
- Intrinsic nephropathy with hematuria over 50 red cells/high power field and dysmorphic erythrocyte and/or proteinuria over 500mg/24h;
- Use of nephrotoxic drugs in the previous 30 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
Accuracy of NGAL to predict no response to albumin expansion
Time frame: One day after albumin expansion (day 3)
We will build a receiver-operating curve and calculate the area under the curve to determine the accuracy of NGAL to predict no response to albumin expansion. No response will be defined as an absence of a drop of serum creatinine to a final value below 1.5mg/dL in the day after the end of albumin expansion. Albumin will be administrated as International Ascites Club recommendations, i.e. in the dose of 1g/kg/day for 2 days in patients with suspected hepatorenal syndrome.
5 secondary outcomes
Accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment
Time frame: Treatment period (maximum of 14 days)
Accuracy of urinary NGAL and other biomarkers to predict development and progression of acute kidney injury (AKI) in patients with bacterial infection
Time frame: During antibiotic therapy and during hospital stay
Predictors of mortality
Time frame: In-hospital, 30 days and 90 days
Urinary NGAL as a predictor of adverse events of AKI treatment in cirrhosis
Time frame: During treatment period
Accuracy of other biomarkers to predict no response to albumin expansion
Time frame: One day after albumin expansion (day 3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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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.
Alberto Q Farias, Associate professor study chair
University of Sao Paulo
4 sites 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 Hepatorenal Syndrome, run by University of Sao Paulo at 4 sites in Brazil.
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 5 inclusion and 7 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. 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 Rafael O Ximenes, MD (+55 011 2661-3338, rximenes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of NGAL to predict no response to albumin expansion (time frame: One day after albumin expansion (day 3)). 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 27 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.