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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury Following Upper Gastrointestinal Bleeding: Incidence and Predictors
- ClinicalTrials.gov ID
- NCT07636083
- Acronym / sponsor ID
- SOHAG-UGIB-AKI-26
- Keywords
- UGIB, AKI, Renal Impairment, Gastrointestinal Hemorrhage, Serum Creatinine, Kidney Function, Variceal Bleeding, Non-variceal Bleeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Acute Upper Gastrointestinal Bleeding | – | Other: Observational assessmentAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational assessmentNo therapeutic intervention is applied. Patients are managed according to standard hospital care, and data are collected observationally. | Other | Patients with Acute Upper Gastrointestinal Bleeding |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 30910853Stanley AJ, Laine L. Management of acute upper gastrointestinal bleeding. BMJ. 2019 Mar 25;364:l536. doi: 10.1136/bmj.l536.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Bleeding and Acute Kidney Injury, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Kidney Injury (AKI) According to KDIGO Criteria (time frame: From hospital admission through hospital discharge, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07636083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.