Using the Peripheral Perfusion Index to guide fluids and prevent acute skin failure in older ICU patients

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

This test will see if adjusting fluid treatment to keep the Peripheral Perfusion Index (PPI) at or above 1.4 reduces acute skin failure in people aged 65 and older in the ICU with sepsis or shock.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Nantong First People's Hospital (other)
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT07367113 on ClinicalTrials.gov

What this trial studies

This was a prospective, randomized, controlled trial that enrolled 216 patients aged 65 years or older with sepsis or other shock requiring early aggressive fluid resuscitation and an APACHE II score ≥15. Patients were randomized 1:1 to a PPI-guided resuscitation protocol targeting PPI ≥1.4 plus conventional hemodynamic goals or to conventional goal-directed fluid resuscitation alone. The primary outcome was the incidence of acute skin failure within 7 days of ICU admission, diagnosed by NPUAP/EPUAP (2014) criteria. Secondary outcomes included time to skin failure, lactate clearance, cumulative fluid balance, organ function measures, and longer-term prognosis.

Who should consider this trial

Good fit: Ideal candidates are ICU patients aged 65 or older with sepsis or shock who require early aggressive fluid resuscitation, have an APACHE II score ≥15, are expected to remain in the ICU ≥72 hours, and can undergo continuous finger pulse oximetry.

Not a fit: Patients with pre-existing stage III or higher pressure injuries, severe dermatologic or peripheral vascular disease, inability to use continuous finger pulse oximetry, contraindications to liberal fluid resuscitation, or expected survival under 24 hours are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, PPI-guided fluid resuscitation could reduce the incidence of acute skin failure and its related complications by better optimizing peripheral perfusion during early resuscitation.

How similar studies have performed: Using peripheral perfusion markers like PPI to guide resuscitation is relatively novel; observational studies link PPI to perfusion and outcomes but randomized evidence specifically showing reduced skin failure is limited.

Eligibility criteria

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.

Where this trial is running

Nantong, Jiangsu

• Nantong First People's Hospital — Nantong, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Ying Wang

Conditions: Sepsis, Septic Shock, Acute Skin Failure