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Not yet recruiting NCT07636083

Acute Kidney Injury in Upper GI Bleeding Patients

— Observational Upper Gastrointestinal Bleeding Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational assessment.
Who it may be relevant to
Registry conditions: Upper Gastrointestinal Bleeding, Acute Kidney Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Acute Kidney Injury Following Upper Gastrointestinal Bleeding: Incidence and Predictors

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Incidence of Acute Kidney Injury (AKI) According to KDIGO Criteria [Time frame: From hospital admission through hospital discharge, up to 30 days]
Secondary outcome measures (2)
  • 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]
  • Change in Serum Creatinine Concentration [Time frame: Through hospital discharge, up to 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Sohag University Hospitals — Sohag

Publications

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

Identifiers

NCT: NCT07636083 · SOHAG-UGIB-AKI-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗