Ischemic HepatitisNCT02015403
To Compare The Efficacy Of N -Acetylcysteine and Standard Therapy Versus Standard Therapy In The Prevention Of Ischemic Hepatitis And Survival Post Upper GI Bleed
A study of Ischemic Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences) emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care Unit) in view of upper GI bleed randomized to two groups GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Hepatitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2013to May 2015
- 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
- Age > 18 and < 75
- Cirrhotics with UGIE (Upper Gastrointestinal Endoscopy ) within last 24 hours.
Who cannot join
- Non cirrhotic
- Hepatocellular carcinoma
- Advanced cardiopulmonary disease
- Pregnancy
- Extrahepatic malignancy
- Patient on anticoagulation therapy
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
Official title: TO COMPARE THE EFFICACY OF N -ACETYLCYSTEINE AND STANDARD THERAPY VERSUS STANDARD THERAPY IN THE PREVENTION OF ISCHEMIC HEPATITIS AND SURVIVAL POST UPPER GI BLEED
Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences) emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care Unit) in view of upper GI bleed randomized to two groups
GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours
GROUP B : 110 Patients will receive standard care only
NAC will be given at following rate :
Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then continuous infusion of 6.25 mg/kg for the remaining 67 hrs
- Conditions
- Ischemic Hepatitis
- Being tested
- Standard Care + NAC (N -ACETYLCYSTEINE), Standard Care (in control arm)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care + NAC (N -ACETYLCYSTEINE)Drug
Standard Care (in control arm)Drug
| Study group | Role | What they receive |
|---|---|---|
| Standard Care + NAC (N-ACETYLCYSTEINE) infusion | Experimental | Not described Receives: Drug: Standard Care + NAC (N -ACETYLCYSTEINE); Drug: Standard Care (in control arm) |
| Standard Care | Active comparator | Not described Receives: Drug: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed.
Measured: Day 5
Secondary outcomes (2)
To study effect of NAC (N -ACETYLCYSTEINE) infusion on 5 day survival post bleed.
Measured: 6 weeks
To study incidence of complication like AKI (Acute Kidney Injury), HE(Hepatic Encepahlopathy) and SBP(Spontaneous Bacterial Peritonitis).
Measured: day 5
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic HepatitisStudies 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
- 220 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
- NCT02015403
- Sponsor's protocol ID
- ILBS-IH-01
- Status last verified
- Mar 2015
- First submitted
- 13 Dec 2013
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Maiwall R, Kumar A, Bhadoria AS, Jindal A, Kumar G, Bhardwaj A, Maras JS, Sharma MK, Sharma BC, Sarin SK. Utility of N-acetylcysteine in ischemic hepatitis in cirrhotics with acute variceal bleed: a randomized controlled trial. Hepatol Int. 2020 Jul;14(4):577-586. doi: 10.1007/s12072-020-10013-5. Epub 2020 Feb 11.
PubMed 32048131
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TO COMPARE THE EFFICACY OF N -ACETYLCYSTEINE AND STANDARD THERAPY VERSUS STANDARD THERAPY IN THE PREVENTION OF ISCHEMIC HEPATITIS AND SURVIVAL POST UPPER GI BLEED
- ClinicalTrials.gov ID
- NCT02015403
- Acronym / sponsor ID
- ILBS-IH-01
- Conditions
- Ischemic Hepatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 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.
Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences) emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care Unit) in view of upper GI bleed randomized to two groups
GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours
GROUP B : 110 Patients will receive standard care only
NAC will be given at following rate :
Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then continuous infusion of 6.25 mg/kg for the remaining 67 hrs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care + NAC (N-ACETYLCYSTEINE) infusion | Experimental | Drug: Standard Care + NAC (N -ACETYLCYSTEINE), Drug: Standard Care (in control arm) |
| Standard Care | Active comparator | Drug: Standard Care (in control arm) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 and < 75
- Cirrhotics with UGIE (Upper Gastrointestinal Endoscopy ) within last 24 hours.
Key exclusion criteria (6 listed)
- Non cirrhotic
- Hepatocellular carcinoma
- Advanced cardiopulmonary disease
- Pregnancy
- Extrahepatic malignancy
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 |
|---|---|---|
| Standard Care + NAC (N -ACETYLCYSTEINE) | Drug | Standard Care + NAC (N-ACETYLCYSTEINE) infusion |
| Standard Care (in control arm) | Drug | Standard Care, Standard Care + NAC (N-ACETYLCYSTEINE) infusion |
Primary outcome
To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed.
Time frame: Day 5
2 secondary outcomes
To study effect of NAC (N -ACETYLCYSTEINE) infusion on 5 day survival post bleed.
Time frame: 6 weeks
To study incidence of complication like AKI (Acute Kidney Injury), HE(Hepatic Encepahlopathy) and SBP(Spontaneous Bacterial Peritonitis).
Time frame: day 5
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 Sep 2019.
- Derived from this study: PubMed 32048131Maiwall R, Kumar A, Bhadoria AS, Jindal A, Kumar G, Bhardwaj A, Maras JS, Sharma MK, Sharma BC, Sarin SK. Utility of N-acetylcysteine in ischemic hepatitis in cirrhotics with acute variceal bleed: a randomized controlled trial. Hepatol Int. 2020 Jul;14(4):577-586. doi: 10.1007/s12072-020-10013-5. Epub 2020 Feb 11.
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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 of Ischemic Hepatitis, 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 2 inclusion and 6 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 Sep 2019. 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 study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed. (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02015403, which also lists 1 linked publication.
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 Sep 2019.