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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ying Wang
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Incidence of Acute Skin Failure（per the NPUAP/EPUAP 2014 Guidelines）
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
eripheral Perfusion Index-guided Fluid Resuscitation Protocol
Intervention: Peripheral Perfusion Index-guided Fluid Resuscitation Protocol (Other)
Conventional Fluid Resuscitation Group
Intervention: Conventional Goal-Directed Fluid Resuscitation (Other)
Outcomes
Primary Outcomes
Incidence of Acute Skin Failure（per the NPUAP/EPUAP 2014 Guidelines）
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Ying Wang
Clinical Professor
Nantong First People's Hospital