Clinical Trial

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

Study acronym: PPI-PROTECT
Recruiting
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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.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-04-10
notable Primary completion pushed: 2026-02 -> 2026-12 2026-04-10
minor Completion pushed: 2026-06 -> 2026-12 2026-04-10
Trial Details
NCT Number NCT07367113
Lead Sponsor Ying Wang
Collaborators: Nantong First People's Hospital
Conditions Sepsis, Septic Shock, Acute Skin Failure
Enrollment 216 participants
Start Date 2025-01-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-09