NCT06680583

Brief 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 of emergency and critical care patient management.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Nov 2024Mar 2027

Study Start

First participant enrolled

November 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

November 4, 2024

Last Update Submit

March 16, 2026

Conditions

Keywords

cirrhosisgastrointestinal bleedingphysical indicatorshock index

Outcome Measures

Primary Outcomes (1)

  • 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

    through study completion, an average of 6 months

Study Arms (1)

cirrhosis

cirrhosis with gastrointestinal bleeding

Other: physical indicators such as shock index relatives

Interventions

shock index relatives indicators used in the prediction of cirrhosis with gastrointestinal bleeding

Also known as: MSI, Age SI, RASI
cirrhosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cirrhosis with gastrointestinal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Martin De Porres Hospital

Tainan, 60069, Taiwan

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisGastrointestinal HemorrhageFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal DiseasesHemorrhage

Study Officials

  • Yeong-Chin Jou Jou, professor

    St. Martin De Porres Hospital Education and Research

    STUDY DIRECTOR

Central Study Contacts

Chia-Hsi Chen, Physician

CONTACT

Chung-Jing Wang, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency and Critical Care Physician

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 8, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

March 11, 2027

Study Completion (Estimated)

March 11, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

This study include the medical privacy of cirrhosis.

Available IPD Datasets

Individual Participant Data Set Access

Locations