Gastrointestinal Bleeding in Critically Ill Patients

Gastrointestinal Bleeding in Critically Ill Patients: Prevalence, Risk Factors, and Clinical Outcomes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Gastrointestinal Hemorrhage

Detailed Description

Gastrointestinal bleeding is a serious complication in critically ill patients and is associated with increased morbidity and mortality. This prospective observational cohort study will include adult patients (≥18 years) admitted to the intensive care units of Assiut University Hospitals.

Patients will be followed during their ICU stay for the occurrence of clinically important gastrointestinal bleeding (overt or occult) occurring ≥24 hours after admission. Clinical, laboratory, and treatment-related data will be collected to identify independent risk factors and to assess associated clinical outcomes.

• Study Type: Observational
• Enrollment (Estimated): 310

Contacts and Locations

• Study Contact: Name: Haidy M Mohamed, Resident; Phone Number: 0 11 50184210; Email: Heidi.18313235@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• - 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)

Exclusion Criteria:

• - 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Independent risk factors for gastrointestinal bleeding	Odds ratios of clinical, laboratory, and treatment-related factors for the occurrence of clinically important gastrointestinal bleeding using multivariable logistic regression analysis.	Up to 30 days
ICU length of stay	Duration of intensive care unit stay in days.	Up to 30 days
Blood transfusion requirement	Number of units of packed red blood cells transfused during the ICU stay.	Up to 30 days
ICU mortality	Proportion of patients who die during the ICU stay.	Up to 30 days
Need for endoscopic or surgical intervention	Proportion of patients requiring endoscopic therapy or surgical intervention for gastrointestinal bleeding.	Up to 30 days

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Ahmed M Ashmawy, prof, Internal Medicine Department, Assiut University Hospitals; Study Chair: AbdelHamid M Aly, Prof, Internal Medicine Department, Assiut University Hospitals

Study record dates

Study Major Dates

• Study Start (Estimated): September 5, 2026
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: ICU; Risk factors; Mortality; Critically ill; Gastrointestinal bleeding; Assiut
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Critical Illness; Gastrointestinal Hemorrhage
• Other Study ID Numbers: GIB-ICU-Assiut-2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No