Gastrointestinal Bleeding in Critically Ill Patients

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07822958

Enrollment

310

Registered

2026-09-16

Start date

2026-09-05

Completion date

2028-06-01

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Gastrointestinal Hemorrhage

Keywords

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

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of clinically important ICU-acquired gastrointestinal bleeding	Up to 30 days	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.

Secondary

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

Contacts

CONTACTHaidy M Mohamed, Resident

Heidi.18313235@med.aun.edu.eg0 11 50184210

STUDY_CHAIRAhmed M Ashmawy, prof

Internal Medicine Department, Assiut University Hospitals

STUDY_CHAIRAbdelHamid M Aly, Prof