Liver CirrhosisNCT03130127
Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis
A study testing Terlipressin in people with Liver Cirrhosis and Portal Hypertension, run by General Hospital of Shenyang Military Region.
Trial summary
Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. It remains unclear about whether or not continuous infusion of terlipressin should be considered. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension, Variceal Hemorrhage
- 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
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A diagnosis of liver cirrhosis;
- Child-Pugh B or C;
- Acute gastroesophageal variceal bleeding;
- Written informed consents. -
Who cannot join
- No liver cirrhosis;
- Child-Pugh class A;
- Acute upper gastrointestinal bleeding unrelated to varices;
- Use of somatostatin or octreotide. -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis: A Prospective Non-randomized Controlled Trial
Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. It remains unclear about whether or not continuous infusion of terlipressin should be considered.
Read the detailed description
Although intravenous bolus infusion of terlipressin is the standard approach, continuous infusion of terlipressin is preferred in clinical practice. The present study is a pilot non-randomized controlled trial to explore the feasibility and safety of continuous infusion of terlipressin for the treatment of acute variceal bleeding in liver cirrhosis.
- Conditions
- Liver Cirrhosis, Portal Hypertension, Variceal Hemorrhage, Bleeding, Esophageal and Gastric Varices
- Being tested
- Terlipressin
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Hemorrhage, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called Glypressin
According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion of terlipressin | Experimental | In our clinical practice, continuous infusion of terlipressin is being employed. Receives: Drug: Terlipressin |
| Bolus infusion of terlipressin | Active comparator | Traditionally, a bolus infusion of terlipressin is recommended. Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 day treatment failure
Death, fresh hematemesis, hypovolaemic shock, or 3 g drop in Hb (9% drop of Ht) within any 24 h period if no transfusion is administered.
Measured: 5 days (120 hours)
Secondary outcomes (1)
Six-week mortality
Death with 6 weeks after treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Jul 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xiaozhong Guo, MD, Principal investigator, General Hospital of Shenyang Military Area
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130127
- Sponsor's protocol ID
- TERLIPRESSIN-LC
- Status last verified
- Feb 2024
- First submitted
- 21 Apr 2017
- Last updated
- 23 Feb 2024
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis: A Prospective Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03130127
- Acronym / sponsor ID
- TERLIPRESSIN-LC
- Conditions
- Liver Cirrhosis, Portal Hypertension, Variceal Hemorrhage, Bleeding, Esophageal and Gastric Varices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Apr 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.
Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. It remains unclear about whether or not continuous infusion of terlipressin should be considered.
Detailed description
Although intravenous bolus infusion of terlipressin is the standard approach, continuous infusion of terlipressin is preferred in clinical practice. The present study is a pilot non-randomized controlled trial to explore the feasibility and safety of continuous infusion of terlipressin for the treatment of acute variceal bleeding in liver cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion of terlipressin | Experimental | Drug: TerlipressinIn our clinical practice, continuous infusion of terlipressin is being employed. |
| Bolus infusion of terlipressin | Active comparator | Drug: TerlipressinTraditionally, a bolus infusion of terlipressin is recommended. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of liver cirrhosis;
- Child-Pugh B or C;
- Acute gastroesophageal variceal bleeding;
- Written informed consents. -
Key exclusion criteria (4 listed)
- No liver cirrhosis;
- Child-Pugh class A;
- Acute upper gastrointestinal bleeding unrelated to varices;
- Use of somatostatin or octreotide. -
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 |
|---|---|---|
| TerlipressinAlso: GlypressinAccording to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis. | Drug | Bolus infusion of terlipressin, Continuous infusion of terlipressin |
Primary outcome
5 day treatment failure
Time frame: 5 days (120 hours)
Death, fresh hematemesis, hypovolaemic shock, or 3 g drop in Hb (9% drop of Ht) within any 24 h period if no transfusion is administered.
1 secondary outcome
Six-week mortality
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Liver Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Xiaozhong Guo, MD principal investigator
General Hospital of Shenyang Military Area
Questions about this trial
What is this clinical trial studying?
A study testing Terlipressin in people with Liver Cirrhosis and Portal Hypertension, run by General Hospital of Shenyang Military Region.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingshun Qi, MD (86-18909881019, xingshunqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 day treatment failure (time frame: 5 days (120 hours)). 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 23 Feb 2024.