A MULTIMODAL APPROACH TO PREDICTING SEPSIS-RELATED ACUTE RENAL INJURY: A PROSPECTIVE COHORT STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 主要终点
- Renal resistance index (RRI)
研究概览
简要总结
In recent studies, it has been reported that the renal resistance index is effective in detecting sepsis-related acute renal failure (SA-AKI) in the early period. Similarly, urinary biomarkers [TIMP-2]*[IGFBP-7], released in response to tubular epithelial cell stress, have been reported to indicate the presence of acute renal injury (AKI) early on, before functional loss occurs (increased creatinine). This observational study aims to evaluate the renal resistance index and urinary biomarker variation in patients diagnosed with sepsis and to investigate their usefulness in the early detection of renal dysfunction that may develop after sepsis.
详细描述
Purpose and Rationale:
Sepsis is a life-threatening condition caused by a dysregulated host response to infection and remains a major cause of morbidity and mortality in intensive care units. Acute kidney injury (AKI) is one of the most frequent complications of sepsis and is associated with prolonged ICU and hospital stay, increased healthcare costs, and higher mortality. Early detection of renal dysfunction in septic patients is therefore crucial to improve clinical outcomes.
The diagnosis of AKI in clinical practice is mainly based on changes in serum creatinine and urine output according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria. However, serum creatinine reflects functional loss of the kidney and may increase only after significant renal injury has already occurred, which may delay the diagnosis of AKI.
Recently, several physiological and biochemical markers have been investigated for earlier detection of AKI. The renal resistive index (RRI), obtained by Doppler ultrasonography of intrarenal arteries, reflects renal vascular resistance and changes in renal hemodynamics. Previous studies suggest that RRI may increase before conventional markers of kidney injury become abnormal and may help identify patients at risk of AKI during the early phase of critical illness.
In addition, urinary biomarkers reflecting tubular cellular stress have been proposed as early indicators of kidney injury. Tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein-7 (IGFBP-7) are released by renal tubular epithelial cells during cellular stress and cell cycle arrest. The combined urinary biomarker product [TIMP-2]•[IGFBP-7] has been shown to identify patients at risk for AKI before increases in serum creatinine occur.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years
- •Diagnosis of sepsis (per Sepsis-3 clinical criteria)
- •RRI measurement feasible at bedside
- •Informed consent from participant or legally authorized representative
排除标准
- •End-stage kidney disease (chronic dialysis) or baseline eGFR <15mL/min/1.73 m²
- •Kidney transplant recipient
- •Anatomic/technical barrier precluding reliable renal Doppler (RRI) assessment
- •Pregnancy
研究组 & 干预措施
Sepsis ICU Cohort
Adult patients (≥ 18 years of age) who are admitted to the intensive care unit with sepsis or who are diagnosed with sepsis during their admission and for whom bedside renal Doppler ultrasonography is feasible will be included in the study. Participants' Renal Resistive Index (RRI) measurements will be evaluated immediately after sepsis diagnosis (T0), at 24 hours (T24), and at 48 hours (T48). Urinary [TIMP-2]*[IGFBP-7] measurements will be taken immediately after sepsis diagnosis (T0) and at 24 hours (T24). Clinical and laboratory data of the patients included in the study will be recorded for up to 72 hours after sepsis diagnosis. No treatment will be administered to the patients by the researchers; all medical care will be provided according to standard practice.
干预措施: Renal Resistive Index (RRI) Doppler Ultrasound (Diagnostic Test)
Sepsis ICU Cohort
Adult patients (≥ 18 years of age) who are admitted to the intensive care unit with sepsis or who are diagnosed with sepsis during their admission and for whom bedside renal Doppler ultrasonography is feasible will be included in the study. Participants' Renal Resistive Index (RRI) measurements will be evaluated immediately after sepsis diagnosis (T0), at 24 hours (T24), and at 48 hours (T48). Urinary [TIMP-2]*[IGFBP-7] measurements will be taken immediately after sepsis diagnosis (T0) and at 24 hours (T24). Clinical and laboratory data of the patients included in the study will be recorded for up to 72 hours after sepsis diagnosis. No treatment will be administered to the patients by the researchers; all medical care will be provided according to standard practice.
干预措施: Urinary TIMP-2 and IGFBP-7 biomarkers (Diagnostic Test)
结局指标
主要结局
Renal resistance index (RRI)
时间窗: Immediately after sepsis diagnosis (T0, baseline, first measurement)
Measurement of renal resistance index by Doppler ultrasonography immediately after sepsis diagnosis
Renal resistance index (RRI)
时间窗: 24 hours after sepsis diagnosis (T24, second measurement)
Measurement of renal resistance index by Doppler ultrasonography after sepsis diagnosis
Renal resistance index (RRI)
时间窗: 48 hours after sepsis diagnosis (T48, third measurement)
Measurement of renal resistance index by Doppler ultrasonography after sepsis diagnosis
Urine [TIMP-2]•[IGFBP-7] biomarker
时间窗: Immediately after diagnosis of sepsis (T0)
Measurement of \[TIMP-2\]•\[IGFBP-7\] in urine immediately after diagnosis of sepsis
Urine [TIMP-2]•[IGFBP-7] biomarker
时间窗: 24 hours after diagnosis of sepsis (T24)
Measurement of \[TIMP-2\]•\[IGFBP-7\] in urine after sepsis diagnosis
次要结局
- Time to onset of sepsis-associated acute kidney injury (SA-AKI)(Up to 1 week after sepsis diagnosis)
- Need for Renal Replacement Therapy (RRT) After Sepsis Diagnosis(Up to 1 week after sepsis diagnosis)
- Length of ICU stay(through study completion, an average of 1 year)
- Length of hospital stay(through study completion, an average of 1 year)
研究者
Eda Macit Aydın
Intensive Care Specialist, M.D.
Ankara Etlik City Hospital