Variceal Rebleeding Rate and InfectionsPhase 4NCT04056806
2- Day vs. 5- Day Terlipressin and Ceftriaxone in the Control Acute Gastroesophageal Variceal Hemorrhage
A Phase 4 study testing Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial in people with Variceal Rebleeding Rate and Infections, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
The use of prophylactic antibiotics in cirrhotics with gastrointestinal bleeding has been a routine clinical practice . It is still unknown whether use of short term vasoconstrictors and antibiotics could have superior acute hemostatic rate. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Variceal Rebleeding Rate and Infections
- What is being tested?
- Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2019to Aug 2022
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were diagnosed to have cirrhosis based on history, physical examinations, image studies or histological examination..
- Age ranges between 20-80 y/o.
- Patients presenting with hematemesis and /or melena within 24 hours of inclusion.
- Esophageal variceal bleeding is controlled by esophageal variceal ligation (EVL). Gastric variceal bleeding is controlled by endoscopic glue ( histoacryl) injection.
- -
Who cannot join
- Uncertain of bleeding source.
- Failure in endoscopic therapy.
- Had variceal bleeding or peptic ulcer bleeding in recent one month
- has evidence of bacterial infections or possible infection at entry ( such as fever > 37.5。 C, white blood cells> 10000/cumm, urine leukocytes >10/ field, pneumonic patches on chest x-ray, ascitic polymorphonuclear cells > 250/cumm, cellulitis or other focal infections).
- 2) ever received antibiotics within 4 weeks before index upper gastrointestinal bleeding.
- 3) presence of cardiopulmonary embarrassment 4) association with uremia and receiving hemodialysis or peritoneal dialysis. 5) presence of deep jaundice (serum bilirubin > 10 mg/dl), hepatic encephalopathy stage III or IV, massive or refractory ascites 6) presence of chronic kidney disease ( serum creatinine > 2 mg/dl) or hepatorenal syndrome 7) Had history of cerebrovascular accident, coronary artery disease, complete AV block or peripheral vascular disorder 6) association with human immunodeficiency virus (HIV) infection, advanced carcinoma or hepatocellular carcinoma Barcelona Club Liver Cancer (BCLC) class C or D.
- 7) allergy to terlipressin, cephalosporins or penicillin 8) pregnancy. 9) Uncooperative or decline to be enrolled
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
E-Da Hospital
Kaohsiung City, 824
Gin-Ho Lo, 975-106-200, ghlo@kimo.com
About this study
Official title: A Prospective, Randomized Controlled Trial of 2- Day vs. 5- Day Terlipressin and Ceftriaxone in the Prevention of Very Early Rebleeding in Patients With Acute Gastroesophageal Variceal Hemorrhage
The use of prophylactic antibiotics in cirrhotics with gastrointestinal bleeding has been a routine clinical practice . It is still unknown whether use of short term vasoconstrictors and antibiotics could have superior acute hemostatic rate.
Thus, the investigators conducted a trial to compare the effectiveness between participants receiving terlipressin and ceftriaxone 5 days and terlipressin and ceftriaxone 2 days after endoscopic therapy in cirrhotic patients presenting with acute gastro-esophageal variceal hemorrhage..
Read the detailed description
Acute gastro-esophageal variceal hemorrhage is a dreadful complication of portal hypertension. Meta-analysis showed that the combination of vasoconstrictor and endoscopic therapy is superior to endoscopic therapy or vasoconstrictor alone in the control of acute esophageal variceal hemorrhage. Bacterial infections are frequently encountered in cirrhotic patients presenting with acute upper gastrointestinal bleeding. The association of bacterial infections to variceal bleeding may increase the occurrence of variceal rebleeding and mortality. A study has shown that antibiotic prophylaxis in patients with acute esophageal variceal hemorrhage may reduce infection as well as prevent rebleeding. Currently, most guidelines recommend that vasoactive drugs should be continued for 3 to 5 days after endoscopic therapy and antibiotics should be instituted for up to 7 days to manage patients with acute esophageal variceal hemorrhage . On the other hand, some studies in recent years implied that short term vasoconstrictors or antibiotics could achieve similar low variceal rebleeding rates. The use of prophylactic antibiotics in cirrhotics with gastrointestinal bleeding for only one single dose or 3 days appeared to be feasible. It is still unknown whether use of short term both vasoconstrictors and antibiotics could have similar acute hemostatic rate.
Thus, the investigators conducted a trial to compare the effectiveness between participants receiving terlipressin and ceftriaxone 5 days and terlipressin and ceftriaxone 2 days after endoscopic therapy in cirrhotic patients presenting with acute gastroesophageal variceal hemorrhage..
- Conditions
- Variceal Rebleeding Rate and Infections
- Being tested
- Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terlipressin 1Mg Powder for Conventional Release Solution for Injection VialDrug
Also called Ceftriaxone 1gm
efficacy comparison between 2 days and 5 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | receiving terlipressin 2mg bolus on enrollment followed by 1mg per 6 hours. Both Terlipressin infusion and Ceftriaxone continue till 48 hours after endoscopic therapy Receives: Drug: Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial |
| Gruoup B | Active comparator | receiving terlipressin 2mg bolus instituted on enrollment followed by 1mg per 6 hours. Ceftriaxone 1gm intravenously dose of ceftriaxone 1gm at 24 h interval. Both Terlipressin infusion and Ceftriaxone continue till 5 days after endoscopic therapy. Receives: Drug: Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of very early rebleeding
The occurrence of variceal rebleeding after initial hemostasis
Measured: 5 days
Secondary outcomes (1)
Bacterial infections, 42-day rebleeding, mortality
Incidence of bacterial infections \& rebleeding, mortality in 6 weeks
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 posted14 Aug 2019
- Study startAug 2019 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Variceal Rebleeding Rate and InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056806
- Sponsor's protocol ID
- EMRP39107N
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 14 Aug 2019
- 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 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial of 2- Day vs. 5- Day Terlipressin and Ceftriaxone in the Prevention of Very Early Rebleeding in Patients With Acute Gastroesophageal Variceal Hemorrhage
- ClinicalTrials.gov ID
- NCT04056806
- Acronym / sponsor ID
- EMRP39107N
- Conditions
- Variceal Rebleeding Rate and Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 14 Aug 2019 (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.
The use of prophylactic antibiotics in cirrhotics with gastrointestinal bleeding has been a routine clinical practice . It is still unknown whether use of short term vasoconstrictors and antibiotics could have superior acute hemostatic rate.
Thus, the investigators conducted a trial to compare the effectiveness between participants receiving terlipressin and ceftriaxone 5 days and terlipressin and ceftriaxone 2 days after endoscopic therapy in cirrhotic patients presenting with acute gastro-esophageal variceal hemorrhage..
Detailed description
Acute gastro-esophageal variceal hemorrhage is a dreadful complication of portal hypertension. Meta-analysis showed that the combination of vasoconstrictor and endoscopic therapy is superior to endoscopic therapy or vasoconstrictor alone in the control of acute esophageal variceal hemorrhage. Bacterial infections are frequently encountered in cirrhotic patients presenting with acute upper gastrointestinal bleeding. The association of bacterial infections to variceal bleeding may increase the occurrence of variceal rebleeding and mortality. A study has shown that antibiotic prophylaxis in patients with acute esophageal variceal hemorrhage may reduce infection as well as prevent rebleeding. Currently, most guidelines recommend that vasoactive drugs should be continued for 3 to 5 days after endoscopic therapy and antibiotics should be instituted for up to 7 days to manage patients with acute esophageal variceal hemorrhage . On the other hand, some studies in recent years implied that short term vasoconstrictors or antibiotics could achieve similar low variceal rebleeding rates. The use of prophylactic antibiotics in cirrhotics with gastrointestinal bleeding for only one single dose or 3 days appeared to be feasible. It is still unknown whether use of short term both vasoconstrictors and antibiotics could have similar acute hemostatic rate.
Thus, the investigators conducted a trial to compare the effectiveness between participants receiving terlipressin and ceftriaxone 5 days and terlipressin and ceftriaxone 2 days after endoscopic therapy in cirrhotic patients presenting with acute gastroesophageal variceal hemorrhage..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vialreceiving terlipressin 2mg bolus on enrollment followed by 1mg per 6 hours. Both Terlipressin infusion and Ceftriaxone continue till 48 hours after endoscopic therapy |
| Gruoup B | Active comparator | Drug: Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vialreceiving terlipressin 2mg bolus instituted on enrollment followed by 1mg per 6 hours. Ceftriaxone 1gm intravenously dose of ceftriaxone 1gm at 24 h interval. Both Terlipressin infusion and Ceftriaxone continue till 5 days after endoscopic therapy. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients were diagnosed to have cirrhosis based on history, physical examinations, image studies or histological examination..
- Age ranges between 20-80 y/o.
- Patients presenting with hematemesis and /or melena within 24 hours of inclusion.
- Esophageal variceal bleeding is controlled by esophageal variceal ligation (EVL). Gastric variceal bleeding is controlled by endoscopic glue ( histoacryl) injection.
- -
Key exclusion criteria (8 listed)
- Uncertain of bleeding source.
- Failure in endoscopic therapy.
- Had variceal bleeding or peptic ulcer bleeding in recent one month
- has evidence of bacterial infections or possible infection at entry ( such as fever > 37.5。 C, white blood cells> 10000/cumm, urine leukocytes >10/ field, pneumonic patches on chest x-ray, ascitic polymorphonuclear cells > 250/cumm, cellulitis or other focal infections).
- 2) ever received antibiotics within 4 weeks before index upper gastrointestinal bleeding.
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 1Mg Powder for Conventional Release Solution for Injection VialAlso: Ceftriaxone 1gmefficacy comparison between 2 days and 5 days | Drug | Group A, Gruoup B |
Primary outcome
incidence of very early rebleeding
Time frame: 5 days
The occurrence of variceal rebleeding after initial hemostasis
1 secondary outcome
Bacterial infections, 42-day rebleeding, 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 14 Aug 2019.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial in people with Variceal Rebleeding Rate and Infections, run by E-DA Hospital at 1 site in Taiwan.
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 5 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: status not confirmed, as of the sponsor's last update on 14 Aug 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Gin-Ho Lo, M.D. (975-106-200, ghlo@kimo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of very early rebleeding (time frame: 5 days). 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 14 Aug 2019.