Acute Kidney Injury in Upper GI Bleeding Patients

NCT07636083 | Not Yet Recruiting

• 1 other identifier: SOHAG-UGIB-AKI-26
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Gastrointestinal Bleeding; Acute Kidney Injury

Keywords

UGIB; AKI; Renal Impairment; Gastrointestinal Hemorrhage; Serum Creatinine; Kidney Function; Variceal Bleeding; Non-variceal Bleeding

Outcome Measures

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.

  From hospital admission through hospital discharge, up to 30 days

Secondary Outcomes (2)

• Percentage of Patients Developing AKI According to Bleeding Etiology

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

• Change in Serum Creatinine Concentration

  Through hospital discharge, up to 30 days

Study Arms (1)

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

Observational assessment OTHER

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

Patients with Acute Upper Gastrointestinal Bleeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, Egypt

Location

Related Publications (1)

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

  PMID: 30910853 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Acute Kidney Injury; Renal Insufficiency

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Internal Medicine

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: June 9, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

EG (1)