Effects of Remote Ischemic Preconditioning on Contrast-Induced Kidney Damage in Diabetic Patients: Link to Oxidative Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Incidence of Contrast-Induced Nephropathy (CIN), defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dL from baseline within 72 hours after contrast exposure
研究概览
简要总结
This study investigates whether remote ischemic preconditioning (RIPC)-a non-invasive technique involving brief cycles of blood flow restriction to the arm-can prevent contrast-induced nephropathy (CIN) in diabetic patients undergoing coronary angiography. Diabetes mellitus increases the risk of CIN due to heightened oxidative stress and disrupted protective cellular signaling.
While previous research suggests that RIPC may activate renal protective mechanisms, its efficacy in diabetic individuals remains controversial, as metabolic and neurovascular alterations may compromise its effect. This randomized trial aims to determine whether RIPC reduces oxidative kidney damage and improves renal outcomes in this high-risk population. The study will also explore the biological basis for potential variability in response, focusing on oxidative stress biomarkers and early kidney injury indicators.
详细描述
This clinical trial explores a non-invasive method known as Remote Ischemic Preconditioning (RIPC) to prevent contrast-induced kidney damage in people with diabetes who are undergoing coronary catheterization. RIPC involves applying brief cycles of restricted blood flow to the arm using a pressure cuff before a medical procedure. Research suggests that RIPC may trigger protective biological responses in distant organs, such as the kidneys, by activating endogenous defense mechanisms including the antioxidant enzyme heme oxygenase-1 (HO-1), and modulation of inflammatory pathways.
The study focuses on a serious complication called Contrast-Induced Nephropathy (CIN)-an acute kidney injury that can occur in patients exposed to contrast dye during medical imaging. CIN is particularly common and severe among individuals with diabetes mellitus and impaired renal function. In this population, the incidence of CIN may reach up to 90%, leading to adverse clinical outcomes and increased healthcare costs.
One major mechanism implicated in CIN is oxidative stress, a state in which excess reactive oxygen species (ROS) overwhelm the body's antioxidant defenses. This imbalance is even more pronounced in diabetic kidneys, where chronic metabolic dysregulation and endothelial dysfunction contribute to heightened susceptibility.
Although early evidence pointed toward a protective role of RIPC against CIN, growing data suggest that its efficacy may be compromised in diabetic individuals. Diabetes-related impairments-including disrupted intracellular signaling, reduced humoral mediator release, autonomic dysfunction, and increased oxidative stress-could attenuate the protective cascade activated by RIPC. Furthermore, peripheral neuropathy, a common complication affecting up to 50% of diabetic patients, may interfere with the neural transmission necessary for systemic RIPC effects.
Nonetheless, clinical studies such as the RenPro Trial have reported preserved RIPC-mediated protection in diabetic populations undergoing contrast exposure. These divergent findings raise important questions about patient-specific factors-including glycemic control, pharmacotherapy, and comorbid conditions-that may modulate the efficacy of this intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patient diagnosed with diabetes mellitus.
- •Age above 18 years.
- •Admission to the ICU due to acute coronary syndrome.
- •Indication for undergoing a coronary arteriography (either urgent or scheduled)
- •Patients who received a coronary arteriography within the last 72 hours (if previously recruited, counted as new for randomization).
- •Possibility to perform the RIPC maneuver without delaying the catheterization
排除标准
- •Absence of diabetes mellitus.
- •Pregnant women.
- •Renal transplant recipients.
- •Patients who underwent urological procedures or received intravenous contrast within the last 72 hours.
- •Diagnosis of end-stage renal disease requiring hemodialysis.
- •Participation in another clinical trial.
研究组 & 干预措施
Remote ischemyc preconditioning.
Participants assigned to this arm received:
- Standard hydration therapy: intravenous infusion of 0.9% saline at 1 ml/kg/h for 12 hours before and after coronary catheterization
- Plus the RIPC procedure: four alternating cycles of upper-arm ischemia (inflating a blood pressure cuff 50 mmHg above systolic pressure for 5 minutes, followed by 5 minutes of reperfusion) performed approximately 45 minutes before catheterization This group was intended to assess the protective renal effects of RIPC in diabetic patients undergoing exposure to intravenous contrast media.
干预措施: Remote Ischemic Preconditioning (Procedure)
Control Arm-NO RIPC
Participants in the control arm receive standard care without remote ischemic preconditioning (RIPC). All patients undergo intravenous hydration as part of standard preventive measures prior to coronary catheterization.
- Intervention: 0.9% saline solution administered intravenously at a rate of 1 ml/kg/hour
- Timing: Initiated 12 hours before the procedure and maintained for 12 hours afterward
- Additional Notes: No cuff inflation or ischemic maneuvers are performed. Patients do not receive sham stimulation or any form of simulated ischemia. This arm reflects usual clinical practice in patients undergoing catheterization who meet inclusion criteria.
结局指标
主要结局
Incidence of Contrast-Induced Nephropathy (CIN), defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dL from baseline within 72 hours after contrast exposure
时间窗: Time Frame: 24, 48, and 72 hours post-contrast administration
* Metric: Absolute change in serum creatinine level (mg/dL) * Time Frame: 24, 48, and 72 hours post-contrast administration * Purpose: Evaluates the incidence and severity of contrast-induced nephropathy (CIN) * Rationale: Creatinine is a key biomarker for acute kidney injury, particularly relevant in diabetic populations receiving iodinated contrast agents
次要结局
- Hospital Readmission Rate(6 weeks post-hospital discharge)
- Clinical Status(6 weeks post-hospital discharge)
- Need for Dialysis(6 weeks post-hospital discharge)
- - Changes in Heme Oxygenase-1 (HO-1) concentration in plasma .(24, 48, and 72 hours after contrast administration)
- Duration of ICU/Hospital Stay.(Up to 30 days post-ICU admission)
- Survival .(6 weeks post-hospital discharge)
研究者
Francisca Rodriguez Mulero
Associate Professor
Universidad de Murcia