Utilizing of Physiological Parameters Predict the Prognos... | NCT06680583

Studies
Utilizing of Physiological Parameters Predict the Prognosis of Cirrhotic Patients With Gastrointestinal Bleeding

NCT06680583

Sponsor

St. Martin De Porress Hospital

Status

Recruiting

Last Update Posted

Mar 17, 2026Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Liver Cirrhosis
Gastrointestinal Bleeding

Interventions

physical indicators such as shock index relatives

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
physical parameters	Registry Identifier	physical parameters

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Mar 11, 2027Estimated

Completion Date

Mar 11, 2027Estimated

First Submitted Date

Nov 4, 2024

First Submission Date that Met QC Criteria

Nov 7, 2024

First Posted Date

Nov 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 17, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chia-hsi Chen, Emergency and Critical Care Physician, St. Martin De Porress HospitalPrincipal Investigator

Lead Sponsor

St. Martin De Porress HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cirrhosis		cirrhosis with gastrointestinal bleeding	Other: physical indicators such as shock index relatives

Interventions

Name	Type	Description	Arm Group Labels	Other Names
physical indicators such as shock index relatives	Other	shock index relatives indicators used in the prediction of cirrhosis with gastrointestinal bleeding	cirrhosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: cirrhosis with gastrointestinal bleeding -

Exclusion Criteria: no complete medical record and trauma patient

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

cirrhosis with gastrointestinal bleeding

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chia-Hsi Chen, Physician	Contact	886-5-2756000	3708	urologist3509@gmail.com
Chung-Jing Wang, professor	Contact	886-5-2756000	3708	medicine@stm.org.tw

Overall Officials

Name	Affiliation	Role
Yeong-Chin Jou Jou, professor	St. Martin De Porres Hospital Education and Research	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Martin De Porres Hospital	Recruiting	Tainan		60069	Taiwan

ID	Type	URL	Comment
	Individual Participant Data Set	View IPD

IPD Sharing Statement Module

Plan to Share IPD

Description

This study include the medical privacy of cirrhosis.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis
D006471	Gastrointestinal Hemorrhage
D005355	Fibrosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided