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NCT Number: NCT07452484

SII in AKI With Cirrhosis

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention needed

Diagnostic Test

No intervention needed

SII

Other

Serial systemic immune inflammation index

Serial systemic immune inflammation index

Diagnostic Test

SII= platelets ×Neutrophils ÷lymphocytes

Primary outcomes

  1. SII measurements

    Time frame: 6 months

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

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Salma Ahmed Fathy Abdu, Resident doctor

CONTACT

[email protected]

01095173942 ext. 01124409602

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.