MorbidityPhase 2Liver-IMPACTNCT06861478
PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease
A Phase 2 study testing Omeprazole 40 mg IV and pantoprazole 40 mg iv in people with Morbidity, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
With this study, the investigators pretend to describe intrahospital morbidity in patients living with cirrhosis (PLC) who present to the emergency department with variceal bleeding (VB). This study is a longitudinal, prospective, experimental, analytical single-center clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbidity
- What is being tested?
- Omeprazole 40 mg IV and pantoprazole 40 mg iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 20 Oct 2024to 20 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- Cirrhosis
- Variceal Bleeding with only endoscopic findings consistent with portal hypertension complications
- Hypovolemic shock and Variceal bleeding
Who cannot join
- Shock of any type other than hypovolemic.
- No cirrhotic patients
- Patients that have severe Hepatic Encephalopathy at admission (West Haven 3 and 4)
- Hepatorenal syndrome
- Acute on chronic with CLIF-C >50 points
- Septic patients
Show all 11Show fewer
- Spontaneous Bacterial Peritonitis
- Elimination Criteria
- Voluntary removal of the study
- Violation of the study protocol
- Patients in the no PBI group that need prolonged mecánica ventilación.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Universitario "Jose E. González" de la Facultad de Medicina, Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460
About this study
Official title: In-Hospital Morbidity Associated With Proton Pump Inhibitors in Acute Variceal Bleeding and Chronic Liver Disease Treatment
With this study, the investigators pretend to describe intrahospital morbidity in patients living with cirrhosis (PLC) who present to the emergency department with variceal bleeding (VB).
This study is a longitudinal, prospective, experimental, analytical single-center clinical trial. The study will be performed in the Hospital Universitario "Jose E. González" de la Factultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.
Read more
The studied population consists of adult-age patients with previous, recent, or new diagnoses of cirrhosis who present to the ED with VH without shock, infection, or acute or chronic disease with a <30% probability of death (CLIF-C <50). The exclusion criteria involve minor age, Acute Liver Failure (ALF), ICU patients, Hepatorenal Syndrome, sepsis or infection, and shock on admission except for hypovolemic and CLIF-C >50 points. Elimination criteria involve patients who want to discontinue treatment and patients with confounding endoscopic findings (Erosive esophagitis, peptic ulcers, duodenal ulcers, bleeding GAVE, and atrophic gastritis).
After the endoscopic intervention, the investigators will propose inclusion. After acceptance with Informed Consent, the investigators will randomize the patients to receive or not receive Omeprazole/ Pantoprazole 40 mg IV per day until discharge. The primary outcome will represent several morbidity situations in these patients, including Hepatic Encephalopathy grades III and IV, intra-hospital infections, re-bleeding, shock, and acute kidney failure.
The secondary outcomes include the individual analysis of each component of our compound primary outcome, mortality by day 30, differences when grouping patients by Child-Pugh stratification, and comparing results in patients receiving omeprazole for more or less than 5 days.
Read the detailed description
This is a prospective, randomized, and blinded study designed to assess the impact of proton pump inhibitor (PPI) use on in-hospital morbidity during acute variceal bleeding in patients with chronic liver disease. The clinical rationale emerges from ongoing debate regarding the safety and utility of acid suppression therapy in this population, particularly during hospitalization for portal hypertension-related bleeding.
Following initial stabilization and confirmation of upper gastrointestinal bleeding, patients undergo diagnostic endoscopy. Upon identification of varices or portal hypertensive gastropathy, eligible individuals are randomized to either continue omeprazole/ pantoprazole (40 mg daily) or discontinue PPI therapy. Randomization is conducted using computer software, and allocation concealment is maintained from the principal investigator.
Standard care protocols-including administration of vasoactive agents, prophylactic antibiotics, and endoscopic therapy-remain unaltered. The only experimental intervention involves PPI exposure during hospitalization. Clinical, biochemical, and radiological data are collected systematically throughout the hospital stay. In patients presenting with ascites, diagnostic paracentesis is performed as indicated. Events including infection, renal dysfunction, rebleeding, encephalopathy, and circulatory failure are monitored until discharge.
This study is being conducted at a tertiary university hospital with advanced endoscopy and critical care infrastructure. Institutional review board approval has been obtained. Written informed consent is obtained from each participant or their legal representative prior to enrollment.
- Conditions
- Morbidity
- Being tested
- Omeprazole 40 mg IV, pantoprazole 40 mg iv
- Keywords
- Variceal Bleeding, Morbidity, Proton Pump Inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole 40 mg IVDrug
Daily until discharge
pantoprazole 40 mg ivDrug
Daily until discharge if omeprazole is unavailable.
| Study group | Role | What they receive |
|---|---|---|
| Proton Bomb Inhibitor | Experimental | These patients are to receive omeprazole or pantoprazole after randomization. Receives: Drug: Omeprazole 40 mg IV; Drug: pantoprazole 40 mg iv |
| No Proton Bomb Inhibitor | No intervention | These patients are not to receive omeprazol after randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
The primary outcome is a composite dichotomous outcome represented by morbidity situations, including Hepatic Encephalopathy, intra-hospital infections, re-bleeding, shock, and acute kidney failure.
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Secondary outcomes (10)
Ocurrence of Hepatic Encefalopathy
Binary outcome yes/ no
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of Acute Kidney Injury
Acute Kidney Failure binary yes/no
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of Shock
All types of shock except hypovolemic
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of Re-bleeding
Re-bleeding after endoscopic intervention
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of any kind of Infection
Infections after randomization
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
In-Hospital Mortality
The investigators will assess Mortality during hospitalization
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Omeprazol <or>5 days morbidity
Patients who received more than or less than 5 days of omeprazole during hospitalization and morbidity
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
30 day Mortality
The investigators will assess mortality by day 30, independently of admission status.
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
60 day Mortality
The investigators will assess mortality by day 60, independently of admission status.
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
90 day Mortality
The investigators will assess mortality by day 60, independently of admission status.
Measured: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start20 Oct 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MorbidityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Andrés González Torres, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861478
- Sponsor's protocol ID
- GA24-00007
- Acronym
- Liver-IMPACT
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will decide after the finishing of this work
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Hospital Morbidity Associated With Proton Pump Inhibitors in Acute Variceal Bleeding and Chronic Liver Disease Treatment
- ClinicalTrials.gov ID
- NCT06861478
- Acronym / sponsor ID
- Liver-IMPACT / GA24-00007
- Conditions
- Morbidity
- Keywords
- Variceal Bleeding, Morbidity, Proton Pump Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 6 Mar 2025 (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.
With this study, the investigators pretend to describe intrahospital morbidity in patients living with cirrhosis (PLC) who present to the emergency department with variceal bleeding (VB).
This study is a longitudinal, prospective, experimental, analytical single-center clinical trial. The study will be performed in the Hospital Universitario "Jose E. González" de la Factultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.
The studied population consists of adult-age patients with previous, recent, or new diagnoses of cirrhosis who present to the ED with VH without shock, infection, or acute or chronic disease with a <30% probability of death (CLIF-C <50). The exclusion criteria involve minor age, Acute Liver Failure (ALF), ICU patients, Hepatorenal Syndrome, sepsis or infection, and shock on admission except for hypovolemic and CLIF-C >50 points. Elimination criteria involve patients who want to discontinue treatment and patients with confounding endoscopic findings (Erosive esophagitis, peptic ulcers, duodenal ulcers, bleeding GAVE, and atrophic gastritis).
After the endoscopic intervention, the investigators will propose inclusion. After acceptance with Informed Consent, the investigators will randomize the patients to receive or not receive Omeprazole/ Pantoprazole 40 mg IV per day until discharge. The primary outcome will represent several morbidity situations in these patients, including Hepatic Encephalopathy grades III and IV, intra-hospital infections, re-bleeding, shock, and acute kidney failure.
The secondary outcomes include the individual analysis of each component of our compound primary outcome, mortality by day 30, differences when grouping patients by Child-Pugh stratification, and comparing results in patients receiving omeprazole for more or less than 5 days.
Detailed description
This is a prospective, randomized, and blinded study designed to assess the impact of proton pump inhibitor (PPI) use on in-hospital morbidity during acute variceal bleeding in patients with chronic liver disease. The clinical rationale emerges from ongoing debate regarding the safety and utility of acid suppression therapy in this population, particularly during hospitalization for portal hypertension-related bleeding.
Following initial stabilization and confirmation of upper gastrointestinal bleeding, patients undergo diagnostic endoscopy. Upon identification of varices or portal hypertensive gastropathy, eligible individuals are randomized to either continue omeprazole/ pantoprazole (40 mg daily) or discontinue PPI therapy. Randomization is conducted using computer software, and allocation concealment is maintained from the principal investigator.
Standard care protocols-including administration of vasoactive agents, prophylactic antibiotics, and endoscopic therapy-remain unaltered. The only experimental intervention involves PPI exposure during hospitalization. Clinical, biochemical, and radiological data are collected systematically throughout the hospital stay. In patients presenting with ascites, diagnostic paracentesis is performed as indicated. Events including infection, renal dysfunction, rebleeding, encephalopathy, and circulatory failure are monitored until discharge.
This study is being conducted at a tertiary university hospital with advanced endoscopy and critical care infrastructure. Institutional review board approval has been obtained. Written informed consent is obtained from each participant or their legal representative prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton Bomb Inhibitor | Experimental | Drug: Omeprazole 40 mg IV, Drug: pantoprazole 40 mg ivThese patients are to receive omeprazole or pantoprazole after randomization. |
| No Proton Bomb Inhibitor | No intervention | –These patients are not to receive omeprazol after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult
- Cirrhosis
- Variceal Bleeding with only endoscopic findings consistent with portal hypertension complications
- Hypovolemic shock and Variceal bleeding
Key exclusion criteria (11 listed)
- Shock of any type other than hypovolemic.
- No cirrhotic patients
- Patients that have severe Hepatic Encephalopathy at admission (West Haven 3 and 4)
- Hepatorenal syndrome
- Acute on chronic with CLIF-C >50 points
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 |
|---|---|---|
| Omeprazole 40 mg IVDaily until discharge | Drug | Proton Bomb Inhibitor |
| pantoprazole 40 mg ivDaily until discharge if omeprazole is unavailable. | Drug | Proton Bomb Inhibitor |
Primary outcome
Morbidity
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
The primary outcome is a composite dichotomous outcome represented by morbidity situations, including Hepatic Encephalopathy, intra-hospital infections, re-bleeding, shock, and acute kidney failure.
10 secondary outcomes
Ocurrence of Hepatic Encefalopathy
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of Acute Kidney Injury
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of Shock
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of Re-bleeding
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of any kind of Infection
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
In-Hospital Mortality
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Omeprazol <or>5 days morbidity
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
30 day Mortality
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
60 day Mortality
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
90 day Mortality
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided. The investigators will decide after the finishing of this work
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omeprazole 40 mg IV and pantoprazole 40 mg iv in people with Morbidity, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 11 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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 Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis A González Torres, MD (+5218116091332, Luis37torres@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.). 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 12 Jun 2026.