SII in AKI With Cirrhosis

NCT07452484 | Not Yet Recruiting

• 1 other identifier: Soh_Med-26-2_3MS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• SII measurements

  6 months

• To compare peak SII between cirrhosis with AKI vs cirrhosis without AKI.

  6 months

Study Arms (1)

Observitional cohort study

Diagnostic Test: No intervention needed; Other: SII; Diagnostic Test: Serial systemic immune inflammation index

Interventions

No intervention needed DIAGNOSTIC_TEST

No intervention needed

Observitional cohort study

SII OTHER

Serial systemic immune inflammation index

Observitional cohort study

Serial systemic immune inflammation index DIAGNOSTIC_TEST

SII= platelets ×Neutrophils ÷lymphocytes

Observitional cohort study

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who develop AKI on top Liver cirrhosis

You may qualify if:

• a) Age ≥18 years
• b) Confirmed liver cirrhosis (Section 5)
• c) Hospital admission for acute decompensation or evaluation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Central Study Contacts

Salma Ahmed Fathy Abdu, Resident doctor

CONTACT

01095173942; salmaahmed15299@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02