CirrhosisNCT03144713
Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
A study testing Terlipressin, Midodrine and Albumin in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Study Population: Patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver and Biliary Sciences. Study Design: Prospective Open Labeled Randomized Controlled Trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Terlipressin, Midodrine and Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 28 May 2017to 30 Apr 2018
- 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
- Patients with cirrhosis who undergo Large volume paracentesis (> 5L)
- Patients with age from 18-75 years
Who cannot join
- Renal failure ( Creatinine>1.5mg/dl)
- Recent Gastrointestinal bleeding within 7 days
- Spontaneous bacterial Peritonitis
- Patients with Cardiovascular disease (Electrocardiogram, 2D Echo)
- Systemic arterial hypertension ( >160/90mmhg) Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome
- Patients with active untreated sepsis
Show all 10Show fewer
- Pregnancy
- Patients with hepatic encephalopathy
- No use of drugs affecting systemic hemodynamic 3 days prior to enrollment
- Refusal to participate
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: Randomized Trial Comparing the Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
- Study Population: Patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver and Biliary Sciences.
- Study Design: Prospective Open Labeled Randomized Controlled Trial.
- Study Period: January 2017 to December 2017
- Intervention- Subjects will be randomized to 3 groups
- All patients will receive Standard medical therapy - Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only
- Monitoring and Assessment: Clinical evaluation will be done at regular intervals.
- Adverse Effects: Rise in blood pressure, arrthymias, hyponatremia and rarely cardiovascular side effects have been noted.
- Stopping Rule: Development of PICD, hypertension ( BP>160/90mmhg-JNC class II)
- Conditions
- Cirrhosis
- Being tested
- Terlipressin, Midodrine, Albumin
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg)
MidodrineDrug
Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg)
AlbuminDrug
Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin | Experimental | Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) Receives: Drug: Terlipressin |
| Midodrine | Active comparator | Midodrine 7.5 mg thrice daily for 3 days. Receives: Drug: Midodrine |
| Standard Medical Therapy | Active comparator | Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping. Receives: Drug: Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).
Measured: Day 6
Secondary outcomes (6)
Number of hospital admission withing 28 days in all the 3 groups
Measured: 28 days
Development of Hyponatremia in all the 3 groups
Hyponatremia is defined as S.Na < 130 meq/dL.
Measured: Day 28
Development of Hepatic Encephalopathy in all the 3 groups
Hepatic Encephalopathy defined as West Haven Grade > 1
Measured: Day 28
Recurrence of ascites in all the 3 groups
Measured: Day 28
Development of Acute Kidney Injury in all the 3 groups
Acute Kidney Injury is defined as increase S.Creatinine by more than 0.3 mg/dL
Measured: Day 28
Survival in all the 3 groups
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start28 May 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 150 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
- NCT03144713
- Sponsor's protocol ID
- ILBS-Cirrhosis-10
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing the Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
- ClinicalTrials.gov ID
- NCT03144713
- Acronym / sponsor ID
- ILBS-Cirrhosis-10
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 28 May 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 9 May 2017 (actual)
- 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.
- Study Population: Patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver and Biliary Sciences.
- Study Design: Prospective Open Labeled Randomized Controlled Trial.
- Study Period: January 2017 to December 2017
- Intervention- Subjects will be randomized to 3 groups
- All patients will receive Standard medical therapy - Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only
- Monitoring and Assessment: Clinical evaluation will be done at regular intervals.
- Adverse Effects: Rise in blood pressure, arrthymias, hyponatremia and rarely cardiovascular side effects have been noted.
- Stopping Rule: Development of PICD, hypertension ( BP>160/90mmhg-JNC class II)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terlipressin | Experimental | Drug: TerlipressinTerlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) |
| Midodrine | Active comparator | Drug: MidodrineMidodrine 7.5 mg thrice daily for 3 days. |
| Standard Medical Therapy | Active comparator | Drug: AlbuminAlbumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with cirrhosis who undergo Large volume paracentesis (> 5L)
- Patients with age from 18-75 years
Key exclusion criteria (10 listed)
- Renal failure ( Creatinine>1.5mg/dl)
- Recent Gastrointestinal bleeding within 7 days
- Spontaneous bacterial Peritonitis
- Patients with Cardiovascular disease (Electrocardiogram, 2D Echo)
- Systemic arterial hypertension ( >160/90mmhg) Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome
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 |
|---|---|---|
| TerlipressinTerlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) | Drug | Terlipressin |
| MidodrineTerlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) | Drug | Midodrine |
| AlbuminAlbumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping. | Drug | Standard Medical Therapy |
Primary outcome
Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).
Time frame: Day 6
6 secondary outcomes
Number of hospital admission withing 28 days in all the 3 groups
Time frame: 28 days
Development of Hyponatremia in all the 3 groups
Time frame: Day 28
Development of Hepatic Encephalopathy in all the 3 groups
Time frame: Day 28
Recurrence of ascites in all the 3 groups
Time frame: Day 28
Development of Acute Kidney Injury in all the 3 groups
Time frame: Day 28
Survival in all the 3 groups
Time frame: Day 28
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 5 Sep 2018.
- Individual participant dataSharing planned: No
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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 Terlipressin, Midodrine and Albumin in people with 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 2 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 5 Sep 2018. 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 Paracentesis Induced Circulatory Dysfunction (PICD). (time frame: Day 6). 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 5 Sep 2018.