Upper Gastrointestinal BleedingNCT07636083
Acute Kidney Injury in Upper GI Bleeding Patients
An observational study of Upper Gastrointestinal Bleeding and Acute Kidney Injury, run by Sohag University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding, Acute Kidney Injury
- What is being tested?
- Observational assessment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2026to 15 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acute Kidney Injury Following Upper Gastrointestinal Bleeding: Incidence and Predictors
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.
- Being tested
- Observational assessment
- Keywords
- UGIB, AKI, Renal Impairment, Gastrointestinal Hemorrhage, Serum Creatinine, Kidney Function, Variceal Bleeding, Non-variceal Bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage, Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessmentOther
No therapeutic intervention is applied. Patients are managed according to standard hospital care, and data are collected observationally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospital admission through hospital discharge, up to 30 days
Secondary outcomes (2)
Percentage of Patients Developing AKI According to Bleeding Etiology
Comparison of AKI incidence between variceal and non-variceal UGIB patients.
Measured: Baseline (hospital admission) with AKI occurrence assessed through hospital discharge, up to 30 days
Change in Serum Creatinine Concentration
Serum creatinine concentration (mg/dL) measured at admission and during hospitalization to assess changes in renal function.
Measured: Through hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Abdelrahim Abdelfattah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636083
- Sponsor's protocol ID
- SOHAG-UGIB-AKI-26
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Stanley AJ, Laine L. Management of acute upper gastrointestinal bleeding. BMJ. 2019 Mar 25;364:l536. doi: 10.1136/bmj.l536.
PubMed 30910853