Effect of Remote Ischemic Preconditioning in Septic Patients on Cell Cycle Arrest Biomarkers - the RIPC-ICU Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1. kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 24h after randomization and [TIMP-2]*[IGFBP7] levels at randomization
研究概览
简要总结
Acute kidney injury is a well-recognized complication in critically ill patients. Up to date there is no clinically established method to reduce the incidence or the severity of acute kidney injury.
Remote ischemic preconditioning (RIPC) will be induced by three cycles of upper limb ischemia.
The aim of the study is to reduce the incidence of AKI by implementing remote ischemic preconditioning (identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor-binding protein 7(IGFBP7)
详细描述
Acute kidney injury (AKI) is a common complication in critically ill patients with sepsis. To date, there is no pharmacological option to treat or prevent AKI.
Ischemic conditioning is an innate tissue adaptation elicited by ischemia that mediates local and remote organ protection against subsequent exposure to the same or other injury.
The aim of this trial is to evaluate the effects of remote ischemic conditioning in critically ill patients on acute kidney injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Adult patients (age ≥18 years)
- •Critically ill patients with sepsis < 12 hours
- •Invasive ventilation for at least 24 hours (propofol-free-sedation) and/or vasopressor therapy
- •Unrestricted intensive care for at least 72 hours
- •Written informed consent
排除标准
- •Pre-existing AKI
- •(Glomerulo-)nephritis, interstitial nephritis, vasculitis
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m²
- •Chronic dialysis dependency
- •Kidney transplant in the last 12 months
- •Oral antidiabetics, sulfonamides or nicorandil
- •Pregnancy or breastfeeding
- •Do-not-reanimate order
- •Participation in another interventional trial involving kidney outcomes within the last 3 months
- •Dependency on the investigator or center
研究组 & 干预措施
Intervention Group
Remote ischemic preconditioning (RIPC) Three Cycles of 5-min upper limb ischemia. If there is no response this will be followed by 2 cycles of 10-min upper-limb ischemia.
干预措施: Remote ischemic preconditioning (RIPC) (Procedure)
Control Group
Three cycles of 5- min upper limb sham ischemia.
干预措施: Sham RIPC (Procedure)
结局指标
主要结局
1. kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 24h after randomization and [TIMP-2]*[IGFBP7] levels at randomization
时间窗: from randomization to 24 hours after randomization
次要结局
- Mortality(day 90 after the onset of sepsis)
- Major adverse kidney events (MAKE) Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more(day 90 after the onset of sepsis)
- Incidence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria(72 hours after the onset of sepsis)
- Severity of AKI(72 hours after the onset of sepsis)
- Need for renal replacement therapy(72 hours after the onset of sepsis)
- Recovery of kidney function(day 90 after the onset of sepsis)
- Length of Intensive Care Unit (ICU) stay(up to 90 days after onset of sepsis)
- Length of hospital stay(up to 90 days after onset of sepsis)