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临床试验/CTRI/2025/08/092882
CTRI/2025/08/092882招募中不适用

Effect of Renal Doppler based Hemodynamic Support titration on the incidence of Acute Kidney Injury in patients with Septic Shock: A Single Blinded Randomized Controlled Trial

All India Institute of Medical Sciences Rishikesh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Acute kidney injury

研究概览

简要总结

Septic shock is defined as a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. Clinically, septic shock is identified by the need for vasopressor therapy to maintain a mean arterial pressure (MAP) of more than or equal to 65 mm Hg, along with a serum lactate level more than 2 mmol per L, despite adequate fluid resuscitation. Septic shock is a distributive shock which results from vasodilation and later damage to the microvascular endothelium resulting in capillary leakage and edema. So, exact titration of fluid becomes very important to maintain organ perfusion and to prevent the development of multi organ dysfunction syndrome (MODS). Organ systems affected in MODS include lungs resulting in acute respiratory distress syndrome (ARDS), kidney resulting in acute kidney injury (AKI), heart resulting in septic cardiomyopathy, brain resulting in septic encephalopathy and so on. Among these complications, AKI is one of the most common, affecting nearly 50 percent of patients in intensive care units. According to the KDIGO (Kidney Disease: Improving Global Outcomes) 2012 Clinical Practice Guidelines, acute kidney injury (AKI) is defined as any of the following: An increase in serum creatinine by more than or equal to 0.3 mg per dL within 48 hours, or an increase in serum creatinine to more than or equal to 1.5 times baseline, known or presumed to have occurred within the prior 7 days, or a urine output less than 0.5 mL per kg per h for 6 hours.

Septic shock patients have developed AKI even with proper monitoring of parameters such as mean arterial pressure, central venous pressure, and lactate. The pathophysiology of AKI is due to variation in perfusion due to hemodynamic instability, excessive venous congestion, inflammation, and cytokine induced circulatory damage. These commonly used methods of monitoring fluid responsiveness have less sensitivity in predicting MODS, as none of these can quantify perfusion at organ level, further necessitating the need for newer indices. Hence the new techniques such as renal doppler have been evaluated to predict the risk of AKI in patients with sepsis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adult patients in septic shock.

排除标准

  • Refusal to consent.
  • Patients with preexisting acute kidney injury.
  • Patients with preexisting renal diseases such as unilateral kidney.
  • renal stone disease, renal failure, renal artery stenosis.
  • Patient having any preexisting cardiopulmonary illness.

结局指标

主要结局

Acute kidney injury

时间窗: Day 7

次要结局

  • Resolution of shock(Within 7 days)
  • Length of ICU stay
  • Length of hospital stay
  • Mortality(till 28 days)
  • PF Ratios(Day 1, 3 and 7)
  • Lactate(Day 1, 3 and 7)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Deepak Singla

All India Institute of Medical Sciences Rishikesh

研究点 (1)

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