Peripheral Perfusion Index-guided Fluid Resuscitation for Preventing Acute Skin Failure in Elderly Critically Ill Patients

Ying Wang216 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

216

Conditions

Sepsis Septic Shock Acute Skin Failure

Interventions

Peripheral Perfusion Index-guided Fluid Resuscitation ProtocolOTHER

In addition to achieving conventional macro-hemodynamic goals (mean arterial pressure ≥65 mmHg, etc.), a resuscitation protocol targeting a Peripheral Perfusion Index (PPI) value ≥1.4 is implemented. PPI is continuously monitored via a finger pulse oximeter. If PPI remains below 1.4 for \>30 minutes, a fluid responsiveness assessment (e.g., passive leg raising test) is performed. Fluid boluses (balanced crystalloid) are administered only if the patient is fluid-responsive. Otherwise, vasoactive agents are optimized.

Conventional Goal-Directed Fluid ResuscitationOTHER

Fluid resuscitation is performed according to the Surviving Sepsis Campaign International Guidelines. Resuscitation targets include: mean arterial pressure ≥65 mmHg, central venous pressure 8-12 mmHg, urine output ≥0.5 mL·kg-¹·h-¹, and normalization/decreasing trend of serum lactate. The type, rate, and volume of fluid administration are determined by the treating physician based on these standard macro-hemodynamic and perfusion parameters.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 65 years. 2. Diagnosis of sepsis (according to Sepsis-3 criteria) or other types of shock requiring early and aggressive fluid resuscitation. 3. APACHE II score ≥ 15 at ICU admission. 4. Expected ICU length of stay ≥ 72 hours. 5. Written informed consent obtained from the patient or their legally authorized representative. Exclusion Criteria: 1. Pre-existing stage III or higher pressure injury or skin necrosis at the time of enrollment. 2. Severe dermatological disease or peripheral vascular disease that could interfere with the assessment of skin or peripheral perfusion. 3. Inability to perform continuous finger pulse oximetry monitoring (e.g., due to bilateral finger injury, amputation, or severe peripheral edema). 4. Contraindications to liberal fluid resuscitation (e.g., acute cardiogenic pulmonary edema, severe heart failure with fluid overload). 5. Expected survival \< 24 hours due to terminal illness or irreversible condition. Concurrent participation in another interventional clinical trial.

Outcomes

Primary Outcomes

Incidence of Acute Skin Failure

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.

Time frame: From ICU admission up to 7 days

Secondary Outcomes

Time to Acute Skin Failure (ASF) Onset

Number of days from ICU admission to the first diagnosis of ASF (assessed in patients who develop ASF)

Time frame: From ICU admission up to 7 days

Maximum Stage of Acute Skin Failure

The most severe stage of ASF (according to NPUAP/EPUAP 2014 criteria) observed within 7 days after ICU admission

Time frame: From ICU admission up to 7 days

Lactate Clearance Rate at 6 Hours

Percentage decrease in serum lactate concentration from baseline to 6 hours after initiation of resuscitation

Time frame: Baseline and 6 hours after resuscitation initiation

Lactate Clearance Rate at 24 Hours

Percentage decrease in serum lactate concentration from baseline to 24 hours after initiation of resuscitation

Time frame: Baseline and 24 hours after resuscitation initiation

Cumulative Fluid Balance at 72 Hours

Net fluid balance (total fluid intake minus total output) calculated over the first 72 hours of ICU stay

Time frame: From ICU admission up to 72 hours

Incidence of Acute Kidney Injury

Proportion of patients who develop AKI according to KDIGO criteria within 7 days after ICU admission

Time frame: From ICU admission up to 7 days

Duration of Mechanical Ventilation

Total number of days requiring invasive mechanical ventilation during ICU stay

Time frame: From ICU admission until ICU discharge, up to 90 days

Length of ICU Stay

Total number of days from ICU admission to ICU discharge

Time frame: From ICU admission until ICU discharge, up to 90 days

28-Day All-Cause Mortality

Proportion of patients who die from any cause within 28 days after ICU admission

Time frame: From ICU admission up to 28 days

90-Day All-Cause Mortality

Proportion of patients who die from any cause within 90 days after ICU admission

Time frame: From ICU admission up to 90 days

Barthel Index at Hospital Discharge

Score of the Barthel Index (a measure of activities of daily living) assessed at the time of hospital discharge in surviving patients. Range: 0-100, higher scores indicate greater independence

Time frame: At hospital discharge, up to 90 days after ICU admission

Total Hospitalization Costs

Total direct medical costs incurred during the index hospitalization, expressed in local currency

Time frame: From hospital admission to hospital discharge, up to 90 days

30-Day Unplanned Readmission Rate

Proportion of patients who have an unplanned readmission to any hospital within 30 days after hospital discharge

Time frame: 30 days after hospital discharge

Incidence of Resuscitation-Related Serious Adverse Events

Proportion of patients who experience serious adverse events related to fluid resuscitation (e.g., new-onset cardiogenic pulmonary edema, arrhythmia requiring intervention) during the ICU stay

Time frame: From ICU admission until ICU discharge, up to 90 days

Peripheral Perfusion Index-guided Fluid Resuscitation for Preventing Acute Skin Failure in Elderly Critically Ill Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts