Gastrointestinal Bleeding in Critically Ill Patients

NCT07822958 | Not Yet Recruiting

• 1 other identifier: GIB-ICU-Assiut-2026
• Study Type: observational
• Target: 310
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective cohort study aims to determine the prevalence of gastrointestinal bleeding among critically ill patients admitted to intensive care units, identify independent risk factors, and describe clinical outcomes including ICU length of stay, transfusion requirements, and mortality at Assiut University Hospitals.

Conditions

Gastrointestinal Hemorrhage; Critical Illness

Keywords

Mortality; Gastrointestinal bleeding; Critically ill; ICU; Risk factors; Assiut

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically important ICU-acquired gastrointestinal bleeding

  Proportion of critically ill patients who develop clinically important gastrointestinal bleeding (overt bleeding with hemodynamic compromise or significant hemoglobin drop, or occult bleeding confirmed by fecal occult blood test or endoscopy) occurring 24 hours or more after ICU admission.

  Up to 30 days

Secondary Outcomes (5)

• Independent risk factors for gastrointestinal bleeding

  Up to 30 days

• ICU length of stay

  Up to 30 days

• Blood transfusion requirement

  Up to 30 days

• ICU mortality

  Up to 30 days

• Need for endoscopic or surgical intervention

  Up to 30 days

Study Arms (1)

Single cohort: Critically ill adult patients admitted to ICU

Adult patients admitted to the intensive care units who will be followed for the occurrence of ICU-acquired gastrointestinal bleeding and its associated risk factors and outcomes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) admitted to the intensive care units of Assiut University Hospitals.

You may qualify if:

• \- Age 18 years or older
• Admission to the intensive care unit
• Onset of gastrointestinal bleeding after ≥24 hours of ICU admission (to distinguish ICU-acquired bleeding)
• Overt gastrointestinal bleeding (hematemesis, melena, hematochezia, or bloody nasogastric aspirate) and/or occult bleeding confirmed by fecal occult blood test or endoscopy
• Written informed consent (from patient or legal representative)

You may not qualify if:

• \- Age less than 18 years
• Pregnancy
• Gastrointestinal bleeding clearly due to trauma or recent gastrointestinal surgery/procedure
• Known bleeding disorder unrelated to critical illness
• Recent receipt of peptic ulcer prophylaxis (two or more doses)
• Incomplete medical records or loss to follow-up
• Refusal to participate

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Critical Illness

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Ahmed M Ashmawy, prof

  Internal Medicine Department, Assiut University Hospitals

  STUDY CHAIR

• AbdelHamid M Aly, Prof

  Internal Medicine Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Haidy M Mohamed, Resident

CONTACT

0 11 50184210; Heidi.18313235@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 16, 2026
• Study Start: September 5, 2026
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09