Acute Kidney InjuryNCT02016053
Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
500 patients with normal renal function will be prospectively studied and incidence, spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied for 1 year. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 450 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2013to May 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 500 patients with normal renal function. 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied.
Who may be able to join
- Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled
Who cannot join
- Age < 18 or > 70 years
- Preexisting Chronic Renal Disease
- Patients with obstructive uropathy.
- Cirrhosis with HCC (HepatoCellular Carcinoma).
- Advanced cardiopulmonary disease
- Pregnancy
- Patients with extrahepatic malignancy
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
500 patients with normal renal function will be prospectively studied and incidence, spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied for 1 year. Also biomarkers will be studied and validated as early predictors of AKI (Acute Kidney Injury).
- Conditions
- Acute Kidney Injury
- 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.
| Study group | Role | What they receive |
|---|---|---|
| cirrhosis with baseline renal function | 500 patients of cirrhosis with normal baseline renal function will be enrolled. | |
| Cirrhosis with Acute Kidney Injury (AKI). | Cirrhotics patients who present with AKI (Acute Kidney Injury) will be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence , spectrum and natural history of Acute Kidney Injury in patients with cirrhosis
Incidence is defined as No. of AKI (Acute Kidney Injury) patients during the follow up period of 1 year.
Spectrum is defined as Grading of AKIN (Acute Kidney Injury Network) 1,2,3 in different child status (Child A,Child B and Child C) at the end .
Natural History is defined as Occurrence of AKI (Acute Kidney Injury) and its recovery during the follow up period of 1 year.
Measured: 1 Year
Secondary outcomes (2)
To study predictive value of Cystatin C in comparison to serum creatinine as early predictor of development and outcome of AKI in a cohort of Cirrhotics.
Measured: 1 Years
To study predictive value of Cystatin C to determine progression or resolution of Acute Kidney Injury
Measured: 1 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2015
- Study completionMay 2015
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 Institute of Liver and Biliary Sciences, 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016053
- Sponsor's protocol ID
- ILBS-AKI-02
- Status last verified
- Nov 2014
- First submitted
- 9 Dec 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02016053
- Acronym / sponsor ID
- ILBS-AKI-02
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Dec 2013 (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.
500 patients with normal renal function will be prospectively studied and incidence, spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied for 1 year. Also biomarkers will be studied and validated as early predictors of AKI (Acute Kidney Injury).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cirrhosis with baseline renal function | – | –500 patients of cirrhosis with normal baseline renal function will be enrolled. |
| Cirrhosis with Acute Kidney Injury (AKI). | – | –Cirrhotics patients who present with AKI (Acute Kidney Injury) will be enrolled. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 patients with normal renal function. 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied.
Key inclusion criteria (1 listed)
- Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled
Key exclusion criteria (7 listed)
- Age < 18 or > 70 years
- Preexisting Chronic Renal Disease
- Patients with obstructive uropathy.
- Cirrhosis with HCC (HepatoCellular Carcinoma).
- Advanced cardiopulmonary disease
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
The incidence , spectrum and natural history of Acute Kidney Injury in patients with cirrhosis
Time frame: 1 Year
Incidence is defined as No. of AKI (Acute Kidney Injury) patients during the follow up period of 1 year. Spectrum is defined as Grading of AKIN (Acute Kidney Injury Network) 1,2,3 in different child status (Child A,Child B and Child C) at the end . Natural History is defined as Occurrence of AKI (Acute Kidney Injury) and its recovery during the follow up period of 1 year.
2 secondary outcomes
To study predictive value of Cystatin C in comparison to serum creatinine as early predictor of development and outcome of AKI in a cohort of Cirrhotics.
Time frame: 1 Years
To study predictive value of Cystatin C to determine progression or resolution of Acute Kidney Injury
Time frame: 1 Years
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 13 Aug 2015.
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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?
An observational study of Acute Kidney Injury, run by Institute of Liver and Biliary Sciences, 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 1 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: finished, as of the sponsor's last update on 13 Aug 2015. 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?
The incidence , spectrum and natural history of Acute Kidney Injury in patients with cirrhosis (time frame: 1 Year). 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 13 Aug 2015.