SII in AKI With Cirrhosis

February 28, 2026 updated by: Salma Ahmed Fathy, Sohag University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who develop AKI on top Liver cirrhosis

Description

Inclusion Criteria:

  • a) Age ≥18 years

    b) Confirmed liver cirrhosis (Section 5)

    c) Hospital admission for acute decompensation or evaluation

Exclusion Criteria:

  • a) ESRD or dialysis dependence.

    b) Kidney transplant recipient.

    c) Pregnancy.

    d) Active malignancy other than HCC.

    e) Massive GI bleeding within 5 days.

    f) Use of nephrotoxic drugs within 7 days (NSAIDs, aminoglycosides, amphotericin, contrast media, chemotherapy ).

    g) Obstructive uropathy .

    h) Active infection at admission (per infection rule-out protocol).

    i) Hematologic disorders affecting CBC (e.g., leukemia, aplastic anemia).

    j) Failure to obtain informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observitional cohort study
Diagnostic test: No intervention needed
No intervention needed
Other: SII
Serial systemic immune inflammation index
Diagnostic test: Serial systemic immune inflammation index
SII= platelets ×Neutrophils ÷lymphocytes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SII measurements
Time Frame: 6 months
6 months
To compare peak SII between cirrhosis with AKI vs cirrhosis without AKI.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Soh_Med-26-2_3MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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