Effect of Peripheral Perfusion Index-guided Fluid Resuscitation on the Prevention of Acute Skin Failure in Elderly Critically Ill Patients: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Incidence of Acute Skin Failure（per the NPUAP/EPUAP 2014 Guidelines）
研究概览
简要总结
This prospective, randomized, controlled trial aimed to evaluate whether fluid resuscitation guided by the Peripheral Perfusion Index (PPI) could reduce the incidence of Acute Skin Failure (ASF) in elderly critically ill patients. A total of 216 patients aged ≥65 years with sepsis or other types of shock requiring early aggressive fluid resuscitation were enrolled and randomly assigned in a 1:1 ratio to either the PPI-guided resuscitation group or the conventional resuscitation group. The intervention group targeted maintaining PPI ≥1.4 in addition to conventional hemodynamic goals, while the control group followed standard resuscitation protocols. The primary outcome was the incidence of ASF within 7 days of ICU admission, diagnosed according to NPUAP/EPUAP (2014) criteria. Secondary outcomes included time to ASF occurrence, lactate clearance, cumulative fluid balance, organ function, and long-term prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years.
- •Diagnosis of sepsis (according to Sepsis-3 criteria) or other types of shock requiring early and aggressive fluid resuscitation.
- •APACHE II score ≥ 15 at ICU admission.
- •Expected ICU length of stay ≥ 72 hours.
- •Written informed consent obtained from the patient or their legally authorized representative.
排除标准
- •Pre-existing stage III or higher pressure injury or skin necrosis at the time of enrollment.
- •Severe dermatological disease or peripheral vascular disease that could interfere with the assessment of skin or peripheral perfusion.
- •Inability to perform continuous finger pulse oximetry monitoring (e.g., due to bilateral finger injury, amputation, or severe peripheral edema).
- •Contraindications to liberal fluid resuscitation (e.g., acute cardiogenic pulmonary edema, severe heart failure with fluid overload).
- •Expected survival < 24 hours due to terminal illness or irreversible condition. Concurrent participation in another interventional clinical trial.
研究组 & 干预措施
eripheral Perfusion Index-guided Fluid Resuscitation Protocol
干预措施: Peripheral Perfusion Index-guided Fluid Resuscitation Protocol (Other)
Conventional Fluid Resuscitation Group
干预措施: Conventional Goal-Directed Fluid Resuscitation (Other)
结局指标
主要结局
Incidence of Acute Skin Failure（per the NPUAP/EPUAP 2014 Guidelines）
时间窗: From ICU admission up to 7 days
Proportion of patients who develop new-onset Acute Skin Failure (ASF) within 7 days after ICU admission. ASF is diagnosed and staged according to the NPUAP/EPUAP (2014) criteria.
Incidence of Acute Skin Failure
时间窗: From ICU admission up to 7 days
Proportion of patients who develop new-onset Acute Skin Failure (ASF) within 7 days after ICU admission. ASF is diagnosed and staged according to the NPUAP/EPUAP (2014) criteria.
次要结局
- Time to Acute Skin Failure (ASF) Onset(From ICU admission up to 7 days)
- Maximum Stage of Acute Skin Failure(From ICU admission up to 7 days)
- Lactate Clearance Rate at 6 Hours(Baseline and 6 hours after resuscitation initiation)
- Lactate Clearance Rate at 24 Hours(Baseline and 24 hours after resuscitation initiation)
- Cumulative Fluid Balance at 72 Hours(From ICU admission up to 72 hours)
- Incidence of Acute Kidney Injury(From ICU admission up to 7 days)
- Duration of Mechanical Ventilation(From ICU admission until ICU discharge, up to 90 days)
- Length of ICU Stay(From ICU admission until ICU discharge, up to 90 days)
- 28-Day All-Cause Mortality(From ICU admission up to 28 days)
- 90-Day All-Cause Mortality(From ICU admission up to 90 days)
- Barthel Index at Hospital Discharge(At hospital discharge, up to 90 days after ICU admission)
- Total Hospitalization Costs(From hospital admission to hospital discharge, up to 90 days)
- 30-Day Unplanned Readmission Rate(30 days after hospital discharge)
- Incidence of Resuscitation-Related Serious Adverse Events(From ICU admission until ICU discharge, up to 90 days)
研究者
Ying Wang
Clinical Professor
Nantong First People's Hospital