Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07636083

Acute Kidney Injury in Upper GI Bleeding Patients

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

Observational Assessment

Other

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

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Percentage of Patients Developing AKI According to Bleeding Etiology

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

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

  2. Change in Serum Creatinine Concentration

    Time frame: Through hospital discharge, up to 30 days

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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Acute Kidney Injury Following Upper Gastrointestinal Bleeding: Incidence and Predictors

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 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.

Published trials that share one or more normalized conditions with this study.