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Not yet recruitingNCT07822958Updated Sep 16, 2026

Gastrointestinal Bleeding in Critically Ill Patients

An observational study in Gastrointestinal Hemorrhage and Critical Illness, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
310
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastrointestinal Hemorrhage
  • Critical Illness

Keywords

  • Mortality
  • Gastrointestinal bleeding
  • Critically ill
  • ICU
  • Risk factors
  • Assiut
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
310 participants (estimated)
Target follow-up
28 Days
Patient registry
Yes

Groups and cohorts

  • 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.

05

What researchers measure

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.

    Time frame: Up to 30 days

Secondary outcomes

  1. 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

  2. ICU length of stay

    Duration of intensive care unit stay in days.

    Time frame: Up to 30 days

  3. Blood transfusion requirement

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

    Time frame: Up to 30 days

  4. ICU mortality

    Proportion of patients who die during the ICU stay.

    Time frame: Up to 30 days

  5. Need for endoscopic or surgical intervention

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

    Time frame: Up to 30 days

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07822958
Lead sponsor
Assiut University
Responsible party
Haidy Mohamed Mahmoud (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 16, 2026
Start date
Sep 5, 2026 (estimated)
Primary completion
Sep 20, 2027 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Sep 16, 2026

Study contacts

Haidy M Mohamed, Resident
Contact
Heidi.18313235@med.aun.edu.eg
0 11 50184210
Ahmed M Ashmawy, prof
study chair · Internal Medicine Department, Assiut University Hospitals
AbdelHamid M Aly, Prof
study chair · Internal Medicine Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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