Gastrointestinal Bleeding in Critically Ill Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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
Disqualifiers
- Age less than 18 years
Pregnancy
Gastrointestinal bleeding clearly due to trauma or recent gastrointestinal surgery/procedure
Known bleeding disorder unrelated to critical illness
Trial population
Adult patients (≥18 years) admitted to the intensive care units of Assiut University Hospitals.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
310 Participants
are grouped into 1 trial groupGroup A: Single cohort: Critically ill adult patients admitted to ICU
Trial outcomes
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 daysSecondary 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 days2
ICU length of stay
Duration of intensive care unit stay in days.
Time frame
Up to 30 days3
Blood transfusion requirement
Number of units of packed red blood cells transfused during the ICU stay.
Time frame
Up to 30 days4
ICU mortality
Proportion of patients who die during the ICU stay.
Time frame
Up to 30 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: