SII in AKI With Cirrhosis

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест No intervention needed
  No intervention needed
• Другое SII
  Serial systemic immune inflammation index
• Диагностический тест Serial systemic immune inflammation index
  SII= platelets ×Neutrophils ÷lymphocytes

Первичные конечные точки

• SII measurements [Срок оценки: 6 months]
• To compare peak SII between cirrhosis with AKI vs cirrhosis without AKI. [Срок оценки: 6 months]

Критерии участия

Критерии включения

• a) Age ≥18 years

b) Confirmed liver cirrhosis (Section 5)

c) Hospital admission for acute decompensation or evaluation

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07452484 · Soh_Med-26-2_3MS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗