Decompensated CirrhosisNCT02467322
To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction in Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.
A study testing Albumin and ascitic fluid in people with Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- Albumin and ascitic fluid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 23 Feb 2015to 15 Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- All Cirrhotics decompensated with ascites admitted in the hospital.
- Grade II/III ascites
- Need for paracentesis.
Who cannot join
- Age <12 or > 75 years
- Hepatocellular carcinoma
- Non cirrhotic ascites such as malignancy or tubercular peritonitis
- Serum Cr >1.5mg%
- Refractory septic shock
- Grade III/IV hepatic encephalopathy
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- Abdominal wall cellulitis
- Active variceal bleed
- Respiratory, cardiac and renal failure
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion
All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres without albumin .
- Conditions
- Decompensated Cirrhosis
- Being tested
- Albumin, ascitic fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminDrug
MVP of less than 5 liters with iv albumin at a dose 8 gms/L of ascitic fluid.
ascitic fluidDrug
| Study group | Role | What they receive |
|---|---|---|
| Albumin | Experimental | MVP (Moderate Volume Paracentesis) of less than 5 liters with iv albumin at a dose 8 gms/l of ascitic fluid. Receives: Drug: Albumin; Drug: ascitic fluid |
| No Albumin | Active comparator | MVP(Moderate Volume Paracentesis) of less than 5 liters without albumin. Receives: Drug: ascitic fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).
Measured: 1 Year
Secondary outcomes (5)
Survival
Measured: 28 days
Total number of patients develop Hepatorenal Syndrome.
Measured: 1 Year
Total number of patients develop hyponatremia.
Measured: 1 Year
Changes in plasma Renin activity.
Measured: 1 Year
Changes in aldosterone with volume of ascitic fluid tap.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start23 Feb 2015
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT02467322
- Sponsor's protocol ID
- ILBS-Cirrhosis-003
- Status last verified
- Oct 2016
- First submitted
- 4 Jun 2015
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion
- ClinicalTrials.gov ID
- NCT02467322
- Acronym / sponsor ID
- ILBS-Cirrhosis-003
- Conditions
- Decompensated Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 23 Feb 2015 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 10 Jun 2015 (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.
All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres without albumin .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin | Experimental | Drug: Albumin, Drug: ascitic fluidMVP (Moderate Volume Paracentesis) of less than 5 liters with iv albumin at a dose 8 gms/l of ascitic fluid. |
| No Albumin | Active comparator | Drug: ascitic fluidMVP(Moderate Volume Paracentesis) of less than 5 liters without albumin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All Cirrhotics decompensated with ascites admitted in the hospital.
- Grade II/III ascites
- Need for paracentesis.
Key exclusion criteria (10 listed)
- Age <12 or > 75 years
- Hepatocellular carcinoma
- Non cirrhotic ascites such as malignancy or tubercular peritonitis
- Serum Cr >1.5mg%
- Refractory septic shock
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 |
|---|---|---|
| AlbuminMVP of less than 5 liters with iv albumin at a dose 8 gms/L of ascitic fluid. | Drug | Albumin |
| ascitic fluid | Drug | Albumin, No Albumin |
Primary outcome
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).
Time frame: 1 Year
5 secondary outcomes
Survival
Time frame: 28 days
Total number of patients develop Hepatorenal Syndrome.
Time frame: 1 Year
Total number of patients develop hyponatremia.
Time frame: 1 Year
Changes in plasma Renin activity.
Time frame: 1 Year
Changes in aldosterone with volume of ascitic fluid tap.
Time frame: 1 year
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 12 Jun 2017.
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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?
A study testing Albumin and ascitic fluid in people with Decompensated Cirrhosis, 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 3 inclusion and 10 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 12 Jun 2017. 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?
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction). (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 12 Jun 2017.