Liver CirrhosisSINCT06680583
Utilizing of Physiological Parameters Predict the Prognosis of Cirrhotic Patients With Gastrointestinal Bleeding
An observational study of Liver Cirrhosis and Gastrointestinal Bleeding, run by St. Martin De Porress Hospital at 1 site in Taiwan.
Trial summary
Can physiological indicators such as quick Sequential Organ Failure Assessment , Shock Index, and its derived indicators such as Modified Shock Index , Age Shock Index and Respiratory Adjusted Shock Index accurately predict the prognosis of cirrhosis patients with gastrointestinal bleeding? To explore the improvement… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis, Gastrointestinal Bleeding
- What is being tested?
- physical indicators such as shock index relatives
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2024to 11 Mar 2027
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cirrhosis with gastrointestinal bleeding
Inclusion Criteria: cirrhosis with gastrointestinal bleeding -
Exclusion Criteria: no complete medical record and trauma patient
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
St. Martin De Porres Hospital
Tainan, 60069
Koa, Miss, 886-5-2756000 ext. 3708, medicine@stm.org
Loa, Miss, 886-5-2756000 ext. 3706, medicine@stm.org
About this study
Official title: Utilizing of Physiological Parameters And Derived Indices to Predict The Prognosis of Cirrhotic Patients With Gastrointestinal Bleeding
Can physiological indicators such as quick Sequential Organ Failure Assessment , Shock Index, and its derived indicators such as Modified Shock Index , Age Shock Index and Respiratory Adjusted Shock Index accurately predict the prognosis of cirrhosis patients with gastrointestinal bleeding? To explore the improvement of emergency and critical care patient management.
Read the detailed description
Cirrhosis is a common chronic liver disease with gastrointestinal bleeding being one of its complications. Gastrointestinal bleeding is quite common in patients with cirrhosis, but its prognosis is difficult to accurately predict. In current clinical practice, critical care physicians often use physiological indicators to assess the risk level of patients. Among them, the Shock Index and its derived indicators such as the Modified Shock Index, Age Shock Index, and Respiratory Adjusted Shock Index have been widely used in other fields, but their actual value in patients with cirrhosis complicated by gastrointestinal bleeding is not yet clear.
The prognosis of cirrhosis patients with gastrointestinal bleeding affects the quality of life and survival of the patients, thus necessitating the establishment of a reliable prognostic assessment tool to assist critical care physicians in making rapid treatment decisions. The motivation of this study is to explore the application value of Shock Index-related indicators in predicting the prognosis of cirrhosis patients with gastrointestinal bleeding, in order to improve the medical efficiency for this specific group of critically ill patients.
- Conditions
- Liver Cirrhosis, Gastrointestinal Bleeding
- Being tested
- physical indicators such as shock index relatives
- Keywords
- cirrhosis, gastrointestinal bleeding, physical indicator, shock index
- Medical subject headings
- Liver Cirrhosis, Gastrointestinal Hemorrhage, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical indicators such as shock index relativesOther
Also called MSI, Age SI, RASI
shock index relatives indicators used in the prediction of cirrhosis with gastrointestinal bleeding
| Study group | Role | What they receive |
|---|---|---|
| cirrhosis | cirrhosis with gastrointestinal bleeding Receives: Other: physical indicators such as shock index relatives |
What is being measured
The primary outcome is the main question the study is designed to answer.
shock index= heart rate / systolic blood pressure normal range:0.5-0.7 Modified shock index = heart rate/mean arterial pressure(MAP) age shock index = SI x age number respiratory adjusted shock index(RASI) = HR/SBP × RR/10. MAP = DP + 1/3(SP - DP)
find the shock index relatives indicators in the prognosis prediction of cirrhosis with gastrointestinal bleeding
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Nov 2024
- Primary completion11 Mar 2027 (estimated)
- Study completion11 Mar 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Martin De Porress Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-hsi Chen, St. Martin De Porress Hospital
- Investigators
- Yeong-Chin Jou Jou, professor, Study director, St. Martin De Porres Hospital Education and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680583
- Sponsor's protocol ID
- St. Martin De Porres Hospital
- Other IDs
- physical parameters
- Acronym
- SI
- Status last verified
- Mar 2026
- First submitted
- 4 Nov 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study include the medical privacy of cirrhosis.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing of Physiological Parameters And Derived Indices to Predict The Prognosis of Cirrhotic Patients With Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT06680583
- Acronym / sponsor ID
- SI / St. Martin De Porres Hospital
- Conditions
- Liver Cirrhosis, Gastrointestinal Bleeding
- Keywords
- cirrhosis, gastrointestinal bleeding, physical indicator, shock index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Martin De Porress HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 11 Mar 2027 (estimated)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 8 Nov 2024 (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.
Can physiological indicators such as quick Sequential Organ Failure Assessment , Shock Index, and its derived indicators such as Modified Shock Index , Age Shock Index and Respiratory Adjusted Shock Index accurately predict the prognosis of cirrhosis patients with gastrointestinal bleeding? To explore the improvement of emergency and critical care patient management.
Detailed description
Cirrhosis is a common chronic liver disease with gastrointestinal bleeding being one of its complications. Gastrointestinal bleeding is quite common in patients with cirrhosis, but its prognosis is difficult to accurately predict. In current clinical practice, critical care physicians often use physiological indicators to assess the risk level of patients. Among them, the Shock Index and its derived indicators such as the Modified Shock Index, Age Shock Index, and Respiratory Adjusted Shock Index have been widely used in other fields, but their actual value in patients with cirrhosis complicated by gastrointestinal bleeding is not yet clear.
The prognosis of cirrhosis patients with gastrointestinal bleeding affects the quality of life and survival of the patients, thus necessitating the establishment of a reliable prognostic assessment tool to assist critical care physicians in making rapid treatment decisions. The motivation of this study is to explore the application value of Shock Index-related indicators in predicting the prognosis of cirrhosis patients with gastrointestinal bleeding, in order to improve the medical efficiency for this specific group of critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cirrhosis | – | Other: physical indicators such as shock index relativescirrhosis with gastrointestinal bleeding |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cirrhosis with 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 |
|---|---|---|
| physical indicators such as shock index relativesAlso: MSI, Age SI, RASIshock index relatives indicators used in the prediction of cirrhosis with gastrointestinal bleeding | Other | cirrhosis |
Primary outcome
shock index= heart rate / systolic blood pressure normal range:0.5-0.7 Modified shock index = heart rate/mean arterial pressure(MAP) age shock index = SI x age number respiratory adjusted shock index(RASI) = HR/SBP × RR/10. MAP = DP + 1/3(SP - DP)
Time frame: through study completion, an average of 6 months
find the shock index relatives indicators in the prognosis prediction of cirrhosis with gastrointestinal bleeding
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 17 Mar 2026.
- Individual participant dataSharing planned: No. This study include the medical privacy of cirrhosis.
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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.
Yeong-Chin Jou Jou, professor study director
St. Martin De Porres Hospital Education and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Gastrointestinal Bleeding, run by St. Martin De Porress Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 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 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.
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 Chia-Hsi Chen, Physician (886-5-2756000 ext. 3708, urologist3509@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shock index= heart rate / systolic blood pressure normal range:0.5-0.7 Modified shock index = heart rate/mean arterial pressure(MAP) age shock index = SI x age number respiratory adjusted shock index(RASI) = HR/SBP × RR/10. MAP = DP + 1/3(SP - DP) (time frame: through study completion, an average of 6 months). 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 17 Mar 2026.