Hepatorenal SyndromeNCT01649037
To Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome
A study testing nor adrenaline and terlipressin and step up terlipressin therapy in people with Hepatorenal Syndrome, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
All consecutive patients with liver cirrhosis having Acute Kidney Injury at admission or during hospitalization will be included in the study. The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatorenal Syndrome
- What is being tested?
- nor adrenaline and terlipressin and step up terlipressin therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2012to Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Liver cirrhosis and acute kidney injury. Patients consented for the study protocol by signing the informed consent.
Who cannot join
- Age less than 18 years Cirrhotics with kidney injury managed as outpatients. Patients undergoing renal replacement therapy (hemodialysis/renal transplantation).
- Post liver transplantation patients. Hepatocellular carcinoma. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.
- Patients with obstructive uropathy. Patient who withdrew or non complaint to the study protocol.
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: A Randomised, Open Label Study to Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome
All consecutive patients with liver cirrhosis having Acute Kidney Injury at admission or during hospitalization will be included in the study.
The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings, and liver histology, when available.
- Conditions
- Hepatorenal Syndrome
- Being tested
- nor adrenaline and terlipressin, step up terlipressin therapy
- Medical subject headings
- Hepatorenal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nor adrenaline and terlipressinDrug
IV bolus terlipressin at the dose of 0.5 to 1 mg every 6 hours with the maximum daily cumulative dose of 4 mg/day.
Continuous IV infusion of NA starting at 0.5 mg/h with doubling of dose after every 4 hours in case of no response.[ No response defined as MAP < 10, or 4 hr Urine output < 200 ml] with maximum dose upto 3 mg/h.
step up terlipressin therapyDrug
IV bolus terlipressin starting at 1.5 mg every 6 hours with increase in dose by 0.5 mg/6 hours in case of no response [< 25% decrease in s.creatinine] after every 48 hours. Maximum daily cumulative dose of 12 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| nor adrenaline and terlipressin | Experimental | Not described Receives: Drug: nor adrenaline and terlipressin |
| step up terlipressin | Active comparator | Not described Receives: Drug: step up terlipressin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Response to treatment in each intervention group
Measured: 2 years
Secondary outcomes (3)
Survival
Measured: 15 days
Side effects of the drug
Measured: 3 months
Complications and the predictors of the treatment response
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatorenal SyndromeStudies 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
- 0 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
- NCT01649037
- Sponsor's protocol ID
- ILBS-AKI-01
- Status last verified
- Dec 2013
- First submitted
- 21 Jul 2012
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open Label Study to Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome
- ClinicalTrials.gov ID
- NCT01649037
- Acronym / sponsor ID
- ILBS-AKI-01
- Conditions
- Hepatorenal Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 25 Jul 2012 (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 with liver cirrhosis having Acute Kidney Injury at admission or during hospitalization will be included in the study.
The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings, and liver histology, when available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nor adrenaline and terlipressin | Experimental | Drug: nor adrenaline and terlipressin |
| step up terlipressin | Active comparator | Drug: step up terlipressin therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Liver cirrhosis and acute kidney injury. Patients consented for the study protocol by signing the informed consent.
Key exclusion criteria (3 listed)
- Age less than 18 years Cirrhotics with kidney injury managed as outpatients. Patients undergoing renal replacement therapy (hemodialysis/renal transplantation).
- Post liver transplantation patients. Hepatocellular carcinoma. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.
- Patients with obstructive uropathy. Patient who withdrew or non complaint to the study protocol.
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 |
|---|---|---|
| nor adrenaline and terlipressinIV bolus terlipressin at the dose of 0.5 to 1 mg every 6 hours with the maximum daily cumulative dose of 4 mg/day. Continuous IV infusion of NA starting at 0.5 mg/h with doubling of dose after every 4 hours in case of no response.[ No response defined as MAP < 10, or 4 hr Urine output < 200 ml] with maximum dose upto 3 mg/h. | Drug | nor adrenaline and terlipressin |
| step up terlipressin therapyIV bolus terlipressin starting at 1.5 mg every 6 hours with increase in dose by 0.5 mg/6 hours in case of no response [< 25% decrease in s.creatinine] after every 48 hours. Maximum daily cumulative dose of 12 mg/day. | Drug | step up terlipressin |
Primary outcome
the Response to treatment in each intervention group
Time frame: 2 years
3 secondary outcomes
Survival
Time frame: 15 days
Side effects of the drug
Time frame: 3 months
Complications and the predictors of the treatment response
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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.
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 nor adrenaline and terlipressin and step up terlipressin therapy in people with Hepatorenal Syndrome, 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 3 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: withdrawn, as of the sponsor's last update on 31 Aug 2016. 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 was withdrawn before enrolling participants, so there are no results.
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 Response to treatment in each intervention group (time frame: 2 years). 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 31 Aug 2016.