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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nantong First People's Hospital
  Nantong, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Ying Wang
• Email: wenquxingdiyi@163.com
• Phone: +86 13485139816

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.