Gastrointestinal Bleeding in Critically Ill Patients

N/ANot Yet RecruitingNCT07822958

Assiut University310 enrolled

Overview

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.

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

310

Conditions

Gastrointestinal Hemorrhage Critical Illness

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 30 days

Secondary Outcomes

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.

Time frame: Up to 30 days

ICU length of stay

Duration of intensive care unit stay in days.

Time frame: Up to 30 days

Blood transfusion requirement

Number of units of packed red blood cells transfused during the ICU stay.

Time frame: Up to 30 days

ICU mortality

Proportion of patients who die during the ICU stay.

Time frame: Up to 30 days

Need for endoscopic or surgical intervention

Proportion of patients requiring endoscopic therapy or surgical intervention for gastrointestinal bleeding.

Time frame: Up to 30 days

Central Contacts

Haidy M Mohamed, Resident

CONTACT

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

Data from ClinicalTrials.gov

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