Acute Variceal BleedingNCT02695862
To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding
A study testing Terlipressin in people with Acute Variceal Bleeding, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The study is single centered; prospective, parallel arm randomized controlled trial.The patients will be who presented to Institute of Liver \& Biliary Sciences with esophageal variceal bleeding or develop esophageal bleeding during hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Variceal Bleeding
- What is being tested?
- Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndia
- Study dates
- 5 May 2016to 31 Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient with only acute esophageal variceal bleeding (as defined by Asian pacific Association for the study of Liver Disease)
- Informed consent to participate in the study
- Age 18 to 70 years
Who cannot join
- Pregnant and lactation
- Prior treatment with any vasoactive drugs
- Significant heart or respiratory failure
- Peripheral arteriopathy clinically significant
- Previous heart stroke or significant alteration of the Electrocardiogram
- Hemodynamically unstable
- Refusal to participate in the study
- Hypertension
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 Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding: A Randomized Comparison
The study is single centered; prospective, parallel arm randomized controlled trial.The patients will be who presented to Institute of Liver \& Biliary Sciences with esophageal variceal bleeding or develop esophageal bleeding during hospital stay. All patients will be managed with continuous non-invasive cardiac and hemodynamic monitoring including cardiac rhythm, pulse rate, blood pressure, and oxygen saturation. Hemoglobin (Hb) will checked every 6 h for the initial 48 h and then every 12 h till discharge. Likewise, serum creatinine will checked daily. Packed red blood cells will be transfused to maintain target Hb of ⩾8 g/dl. Patients will be started on IV Proton Pump Inhibitor, with bolus dose of terlipressin (2mg) followed by Endoscopic variceal ligation. All patients will received prophylactic antibiotics; antibiotics will be stopped if there will no other indication to continue. After confirmation of EVB (Esophageal Variceal Bleeding) and successful initial hemostasis with emergency EVBL (Endoscopic Variceal Band ligation), patients will be randomly assigned into Group -A (Bolus terlipressin at 2mg every 4hourly) and Group-B (Continuous infusion of terlipressin @ 4mg/24hour initially) therapy for esophageal varices . They will then undergo HVPG (Hepatic Venous Pressure Gradient) measurement at baseline, 12hours and 24hours. Patient in continuous group will titrate dose. accordingly to HVPG (Hepatic Venous Pressure Gradient) measurement at 12 and 24 hours. At 24 hours patient will be directed to receive either TIPS (Transjugular Intrahepatic Portosystemic Shunt) or will continue Terlipressin for 48 hours.
- Conditions
- Acute Variceal Bleeding
- Being tested
- Terlipressin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
| Study group | Role | What they receive |
|---|---|---|
| Bolus Terlipressin | Experimental | Injection terlipressin after 2 mg bolus it will be given 2 mg QID Receives: Drug: Terlipressin |
| Terlipressin continuous(4mg/24hours) | Active comparator | Injection terlipressin after 2 mg bolus it will be given 4 mg over 24 hours,and dose will be titrated as per HVPG (Hepatic Venous Pressure Gradient) Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of HVPG (hepatic venous pressure gradient) at 24 hours >10%
Measured: 24 hours
Secondary outcomes (7)
Death in both groups
Measured: 42 days
Terlipressin related complications in both groups
Measured: 72 hours
Rebleed within 42 days
Measured: 42 days
number of blood transfusion requirement at 5 days
Measured: 5 days
Incidence of ischaemic hepatitis within 5 days
Measured: 5 days
Incidence of post bleed acute kidney injury within 5 days
Measured: 5 days
Incidence of post EVL(endoscopic band ligation) ulcer bleed within 5 days
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study start5 May 2016
- Primary completion10 Dec 2017
- Study completion31 Jan 2018
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 Acute Variceal BleedingStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Shakti P Choudhury, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695862
- Sponsor's protocol ID
- ILBS-AVB-001
- Status last verified
- Sep 2017
- First submitted
- 25 Feb 2016
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Arora V, Choudhary SP, Maiwall R, Vijayaraghavan R, Jindal A, Kumar G, Sarin SK. Low-dose continuous terlipressin infusion is effective and safer than intravenous bolus injections in reducing portal pressure and control of acute variceal bleeding. Hepatol Int. 2023 Feb;17(1):131-138. doi: 10.1007/s12072-022-10416-6. Epub 2022 Dec 21.
PubMed 36542261
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding: A Randomized Comparison
- ClinicalTrials.gov ID
- NCT02695862
- Acronym / sponsor ID
- ILBS-AVB-001
- Conditions
- Acute Variceal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 5 May 2016 (actual)
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 1 Mar 2016 (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.
The study is single centered; prospective, parallel arm randomized controlled trial.The patients will be who presented to Institute of Liver \& Biliary Sciences with esophageal variceal bleeding or develop esophageal bleeding during hospital stay. All patients will be managed with continuous non-invasive cardiac and hemodynamic monitoring including cardiac rhythm, pulse rate, blood pressure, and oxygen saturation. Hemoglobin (Hb) will checked every 6 h for the initial 48 h and then every 12 h till discharge. Likewise, serum creatinine will checked daily. Packed red blood cells will be transfused to maintain target Hb of ⩾8 g/dl. Patients will be started on IV Proton Pump Inhibitor, with bolus dose of terlipressin (2mg) followed by Endoscopic variceal ligation. All patients will received prophylactic antibiotics; antibiotics will be stopped if there will no other indication to continue. After confirmation of EVB (Esophageal Variceal Bleeding) and successful initial hemostasis with emergency EVBL (Endoscopic Variceal Band ligation), patients will be randomly assigned into Group -A (Bolus terlipressin at 2mg every 4hourly) and Group-B (Continuous infusion of terlipressin @ 4mg/24hour initially) therapy for esophageal varices . They will then undergo HVPG (Hepatic Venous Pressure Gradient) measurement at baseline, 12hours and 24hours. Patient in continuous group will titrate dose. accordingly to HVPG (Hepatic Venous Pressure Gradient) measurement at 12 and 24 hours. At 24 hours patient will be directed to receive either TIPS (Transjugular Intrahepatic Portosystemic Shunt) or will continue Terlipressin for 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus Terlipressin | Experimental | Drug: TerlipressinInjection terlipressin after 2 mg bolus it will be given 2 mg QID |
| Terlipressin continuous(4mg/24hours) | Active comparator | Drug: TerlipressinInjection terlipressin after 2 mg bolus it will be given 4 mg over 24 hours,and dose will be titrated as per HVPG (Hepatic Venous Pressure Gradient) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient with only acute esophageal variceal bleeding (as defined by Asian pacific Association for the study of Liver Disease)
- Informed consent to participate in the study
- Age 18 to 70 years
Key exclusion criteria (8 listed)
- Pregnant and lactation
- Prior treatment with any vasoactive drugs
- Significant heart or respiratory failure
- Peripheral arteriopathy clinically significant
- Previous heart stroke or significant alteration of the Electrocardiogram
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 |
|---|---|---|
| Terlipressin | Drug | Bolus Terlipressin, Terlipressin continuous(4mg/24hours) |
Primary outcome
Reduction of HVPG (hepatic venous pressure gradient) at 24 hours >10%
Time frame: 24 hours
7 secondary outcomes
Death in both groups
Time frame: 42 days
Terlipressin related complications in both groups
Time frame: 72 hours
Rebleed within 42 days
Time frame: 42 days
number of blood transfusion requirement at 5 days
Time frame: 5 days
Incidence of ischaemic hepatitis within 5 days
Time frame: 5 days
Incidence of post bleed acute kidney injury within 5 days
Time frame: 5 days
Incidence of post EVL(endoscopic band ligation) ulcer bleed within 5 days
Time frame: 5 days
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 4 Sep 2019.
- Derived from this study: PubMed 36542261Arora V, Choudhary SP, Maiwall R, Vijayaraghavan R, Jindal A, Kumar G, Sarin SK. Low-dose continuous terlipressin infusion is effective and safer than intravenous bolus injections in reducing portal pressure and control of acute variceal bleeding. Hepatol Int. 2023 Feb;17(1):131-138. doi: 10.1007/s12072-022-10416-6. Epub 2022 Dec 21.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Variceal Bleeding
Active, not recruiting
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Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction
Liver Cirrhosis
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Keverprazan vs Pantoprazole for the Treatment of ANVUGIB
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PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease
Morbidity
Not yet recruitingObservational study
Acute Kidney Injury in Upper GI Bleeding Patients
Upper Gastrointestinal Bleeding, Acute Kidney Injury
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.
Dr Shakti P Choudhury, MD principal investigator
Institute of Liver and Biliary Sciences, India
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 in people with Acute Variceal Bleeding, 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 8 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 4 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?
Reduction of HVPG (hepatic venous pressure gradient) at 24 hours >10% (time frame: 24 hours). 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 NCT02695862, 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 4 Sep 2019.