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Not yet recruitingNCT07636083Updated Jun 9, 2026

Acute Kidney Injury in Upper GI Bleeding Patients

An observational study in Upper Gastrointestinal Bleeding and Acute Kidney Injury, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study summary

This study aims to evaluate the incidence of acute kidney injury (AKI) among patients presenting with acute upper gastrointestinal bleeding (UGIB) at Sohag University Hospitals, and to identify predictors associated with renal impairment in these patients.

Read the detailed description

Upper gastrointestinal bleeding (UGIB) is a common medical emergency associated with significant morbidity and mortality. Acute kidney injury (AKI) is frequently observed in these patients, mainly due to hypovolemia and renal hypoperfusion. Despite its clinical importance, data regarding AKI incidence and predictors in UGIB patients, particularly in Middle Eastern populations, remain limited.

This prospective observational study aims to assess renal function abnormalities and identify predictors of AKI in patients with UGIB, including both variceal and non-variceal causes. The study will also evaluate clinical outcomes such as mortality, hospital stay duration, and need for renal replacement therapy.

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Conditions studied

  • Upper Gastrointestinal Bleeding
  • Acute Kidney Injury

Keywords

  • UGIB
  • AKI
  • Renal Impairment
  • Gastrointestinal Hemorrhage
  • Serum Creatinine
  • Kidney Function
  • Variceal Bleeding
  • Non-variceal Bleeding
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In context

Gastrointestinal Hemorrhage

339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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 presenting with acute upper gastrointestinal bleeding and admitted to Sohag University Hospitals, including both ward and ICU patients, who meet the eligibility criteria and have available renal function data.

Inclusion criteria

  • Adult patients aged 18 years or older
  • Patients presenting with clinical features suggestive of acute upper gastrointestinal bleeding (UGIB), including hematemesis, coffee-ground vomiting, or melena
  • Diagnosis of UGIB confirmed by upper gastrointestinal endoscopy or strong clinical evidence when endoscopy is not immediately available
  • Patients admitted to Sohag University Hospitals (medical wards or intensive care unit)
  • Availability of renal function data, including at least one serum creatinine measurement at admission and serial measurements during hospitalization
  • Availability of baseline renal function (previous serum creatinine within 3-12 months) or estimable baseline during hospitalization

Exclusion criteria

Exclusion Criteria:

  • Patients with end-stage renal disease (ESRD) on chronic dialysis
  • Patients with a history of renal transplantation
  • Patients with advanced chronic kidney disease stage 5 (eGFR \<15 mL/min/1.73 m²) not on dialysis
  • Patients with lower gastrointestinal bleeding
  • Patients with incomplete or missing essential renal function data
  • Patients discharged or deceased within 24 hours of hospital admission
  • Pregnant patients
  • Patients with acute kidney injury at presentation due to causes other than UGIB
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with Acute Upper Gastrointestinal Bleeding

    Adult patients (≥18 years) presenting with acute upper gastrointestinal bleeding (UGIB) and admitted to Sohag University Hospitals. Patients will be followed prospectively to assess the incidence of acute kidney injury (AKI) and its predictors.

    Other: Observational assessment

Interventions

  • OtherObservational assessment

    No therapeutic intervention is applied. Patients are managed according to standard hospital care, and data are collected observationally.

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What researchers measure

Primary outcomes

  1. Incidence of Acute Kidney Injury (AKI) According to KDIGO Criteria

    The incidence of acute kidney injury (AKI) among patients presenting with acute upper gastrointestinal bleeding (UGIB), defined according to KDIGO criteria based on changes in serum creatinine and/or urine output during hospitalization.

    Time frame: From hospital admission through hospital discharge, up to 30 days

Secondary outcomes

  1. Percentage of Patients Developing AKI According to Bleeding Etiology

    Comparison of AKI incidence between variceal and non-variceal UGIB patients.

    Time frame: Baseline (hospital admission) with AKI occurrence assessed through hospital discharge, up to 30 days

  2. Change in Serum Creatinine Concentration

    Serum creatinine concentration (mg/dL) measured at admission and during hospitalization to assess changes in renal function.

    Time frame: Through hospital discharge, up to 30 days

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Study locations

1 site
  • Sohag University Hospitals
    Sohag, Egypt
08

References and documents

Publications

  • Stanley AJ, Laine L. Management of acute upper gastrointestinal bleeding. BMJ. 2019 Mar 25;364:l536. doi: 10.1136/bmj.l536. PubMed 30910853 ↗

Individual participant data

Plan to share: Undecided — A decision regarding sharing individual participant data (IPD) has not yet been finalized. Any future data sharing will be considered in accordance with institutional policies and participant consent.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07636083
Lead sponsor
Sohag University
Responsible party
Walaa Abdelrahim Abdelfattah (Resident of Internal Medicine, Sohag University) — Principal investigator
First posted
Jun 9, 2026
Start date
May 15, 2026 (estimated)
Primary completion
Jan 15, 2027 (estimated)
Completion
May 15, 2027 (estimated)
Last update
Jun 9, 2026

Oversight

Data monitoring committee
No
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 May 2026. You cannot join it, but the record below documents what was studied.

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