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SII in AKI With Cirrhosis

Serial Systemic Immune Inflammation Index Measurements as a Diagnostic and Prognostic Tool for AKI in Cirrhotic Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07452484
Enrollment
100
Registered
2026-03-05
Start date
2026-03-01
Completion date
2026-10-01
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AKI in Cirrhosis

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.

Interventions

DIAGNOSTIC_TESTNo intervention needed

No intervention needed

OTHERSII

Serial systemic immune inflammation index

DIAGNOSTIC_TESTSerial systemic immune inflammation index

SII= platelets ×Neutrophils ÷lymphocytes

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
SII measurements6 months
To compare peak SII between cirrhosis with AKI vs cirrhosis without AKI.6 months

Contacts

CONTACTSalma Ahmed Fathy Abdu, Resident doctor
salmaahmed15299@gmail.com01095173942

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026