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临床试验/NCT07452484
NCT07452484尚未招募不适用

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

Sohag University0 个研究点目标入组 100 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
SII measurements

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Observitional cohort study

干预措施: No intervention needed (Diagnostic Test)

Observitional cohort study

干预措施: SII (Other)

Observitional cohort study

干预措施: Serial systemic immune inflammation index (Diagnostic Test)

结局指标

主要结局

SII measurements

时间窗: 6 months

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

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salma Ahmed Fathy

Resident doctor

Sohag University

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