AKI in CirrhosisNCT07452484
SII in AKI With Cirrhosis
An observational study of AKI in Cirrhosis, run by Sohag University.
Trial summary
Acute Kidney Injury (AKI) is a common and serious complication in patients withAcute Kidney Injury (AKI) is a common and serious complication in patients with liver cirrhosis, affecting up to 20-50% of hospitalized cirrhotics and contributing significantly to morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- AKI in Cirrhosis
- What is being tested?
- SII and Serial systemic immune inflammation index
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Oct 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who develop AKI on top Liver cirrhosis
Who may be able to join
- a) Age ≥18 years
- Confirmed liver cirrhosis (Section 5)
- Hospital admission for acute decompensation or evaluation
Who cannot join
- a) ESRD or dialysis dependence.
- Kidney transplant recipient.
- Pregnancy.
- Active malignancy other than HCC.
- Massive GI bleeding within 5 days.
- Use of nephrotoxic drugs within 7 days (NSAIDs, aminoglycosides, amphotericin, contrast media, chemotherapy ).
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- Obstructive uropathy .
- Active infection at admission (per infection rule-out protocol).
- Hematologic disorders affecting CBC (e.g., leukemia, aplastic anemia).
- Failure to obtain informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Salma Ahmed Fathy Abdu, Resident doctor contact
About this study
Official title: Serial Systemic Immune Inflammation Index Measurements as a Diagnostic and Prognostic Tool for AKI in Cirrhotic Patients
Acute Kidney Injury (AKI) is a common and serious complication in patients withAcute Kidney Injury (AKI) is a common and serious complication in patients with liver cirrhosis, affecting up to 20-50% of hospitalized cirrhotics and contributing significantly to morbidity and mortality. The pathophysiology is complex and includes Prerenal AKI due to hypovolemia, Hepatorenal Syndrome-AKI (HRS-AKI) resulting from systemic and renal vasoconstriction, and Acute Tubular Necrosis (ATN) from ischemic or nephrotoxic insults . Accurate differentiation between these etiologies is critical, as each requires a distinct management strategy-volume expansion for prerenal AKI, vasoconstrictors for HRS-AKI, and supportive care or renal replacement therapy for ATN . Early recognition of AKI subtype is therefore essential to improve patient outcoment out Serum creatinine (sCr) is the conventional biomarker for AKI diagnosis and staging. However, in cirrhotic patients, sCr is often unreliable due to reduced hepatic creatinine production, decreased skeletal muscle mass (sarcopenia), and fluid overload While previous studies have reported SII at single time points, serial SII measurements provide dynamic insight into the evolution of systemic inflammation and kidney injury. In cirrhotic patients, fluctuations in SII over the first 24-72 hours may detect AKI earlier than sCr, differentiate between etiologies (Prerenal, HRS-AKI, ATN), and predict in-hospital mortality . This approach is particularly valuable in cirrhosis, where traditional markers are unreliable, and could inform timely interventions and risk stratification, representing a novel application of a readily available laboratory index in a high-risk population.
- Conditions
- AKI in Cirrhosis
- Being tested
- No intervention needed, SII, Serial systemic immune inflammation index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention neededDiagnostic test
No intervention needed
SIIOther
Serial systemic immune inflammation index
Serial systemic immune inflammation indexDiagnostic test
SII= platelets ×Neutrophils ÷lymphocytes
| Study group | Role | What they receive |
|---|---|---|
| Observitional cohort study | Not described Receives: Diagnostic Test: No intervention needed; Other: SII; Diagnostic Test: Serial systemic immune inflammation index |
What is being measured
The primary outcome is the main question the study is designed to answer.
SII measurements
Measured: 6 months
To compare peak SII between cirrhosis with AKI vs cirrhosis without AKI.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI in CirrhosisStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Ahmed Fathy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452484
- Sponsor's protocol ID
- Soh_Med-26-2_3MS
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Systemic Immune Inflammation Index Measurements as a Diagnostic and Prognostic Tool for AKI in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT07452484
- Acronym / sponsor ID
- Soh_Med-26-2_3MS
- Conditions
- AKI in Cirrhosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Mar 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.
Acute Kidney Injury (AKI) is a common and serious complication in patients withAcute Kidney Injury (AKI) is a common and serious complication in patients with liver cirrhosis, affecting up to 20-50% of hospitalized cirrhotics and contributing significantly to morbidity and mortality. The pathophysiology is complex and includes Prerenal AKI due to hypovolemia, Hepatorenal Syndrome-AKI (HRS-AKI) resulting from systemic and renal vasoconstriction, and Acute Tubular Necrosis (ATN) from ischemic or nephrotoxic insults . Accurate differentiation between these etiologies is critical, as each requires a distinct management strategy-volume expansion for prerenal AKI, vasoconstrictors for HRS-AKI, and supportive care or renal replacement therapy for ATN . Early recognition of AKI subtype is therefore essential to improve patient outcoment out Serum creatinine (sCr) is the conventional biomarker for AKI diagnosis and staging. However, in cirrhotic patients, sCr is often unreliable due to reduced hepatic creatinine production, decreased skeletal muscle mass (sarcopenia), and fluid overload While previous studies have reported SII at single time points, serial SII measurements provide dynamic insight into the evolution of systemic inflammation and kidney injury. In cirrhotic patients, fluctuations in SII over the first 24-72 hours may detect AKI earlier than sCr, differentiate between etiologies (Prerenal, HRS-AKI, ATN), and predict in-hospital mortality . This approach is particularly valuable in cirrhosis, where traditional markers are unreliable, and could inform timely interventions and risk stratification, representing a novel application of a readily available laboratory index in a high-risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observitional cohort study | – | Diagnostic Test: No intervention needed, Other: SII, Diagnostic Test: Serial systemic immune inflammation index |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who develop AKI on top Liver cirrhosis
Key inclusion criteria (3 listed)
- a) Age ≥18 years
Key exclusion criteria (10 listed)
- a) ESRD or dialysis dependence.
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 |
|---|---|---|
| No intervention neededNo intervention needed | Diagnostic test | Observitional cohort study |
| SIISerial systemic immune inflammation index | Other | Observitional cohort study |
| Serial systemic immune inflammation indexSII= platelets ×Neutrophils ÷lymphocytes | Diagnostic test | Observitional cohort study |
Primary outcome
SII measurements
Time frame: 6 months
To compare peak SII between cirrhosis with AKI vs cirrhosis without AKI.
Time frame: 6 months
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 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for AKI in Cirrhosis
Not yet recruitingObservational study
Predictors of Mortality in Cirrhotic Patients With Acute Kidney Injury
AKI in Cirrhosis
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Study to Evaluate the Efficacy of Intravenous Administration of Human Albumin Versus Saline Solution in Patients With descompénsate Cirrhosis Grade 1B or Higher Renal Failure
Decompensated Cirrhosis, AKI - Acute Kidney Injury
Recruiting
HRS-AKI Treatment With TIPS in Patients With Cirrhosis
Cirrhosis, Liver, Hepatorenal Syndrome
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.
Salma Ahmed Fathy Abdu, Resident doctor contact
Questions about this trial
What is this clinical trial studying?
An observational study of AKI in Cirrhosis, run by Sohag University.
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 3 inclusion and 10 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 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Salma Ahmed Fathy Abdu, Resident doctor (01095173942 ext. 01124409602, salmaahmed15299@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SII measurements (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.