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NCT Number: NCT07822958

Gastrointestinal Bleeding in Critically Ill Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of clinically important ICU-acquired gastrointestinal bleeding

    Time frame: 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 outcomes

  1. Independent risk factors for gastrointestinal bleeding

    Time frame: 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.

  2. ICU length of stay

    Time frame: Up to 30 days

    Duration of intensive care unit stay in days.

  3. Blood transfusion requirement

    Time frame: Up to 30 days

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

  4. ICU mortality

    Time frame: Up to 30 days

    Proportion of patients who die during the ICU stay.

  5. Need for endoscopic or surgical intervention

    Time frame: Up to 30 days

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

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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