Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT07367113

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

Led by Ying Wang · Updated on 2026-04-09

216

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

Sponsors

Y

Ying Wang

Lead Sponsor

N

Nantong First People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Diagnosis of sepsis or other shock requiring early and aggressive fluid resuscitation
  • APACHE II score of 15 or higher at ICU admission
  • Expected ICU stay of 72 hours or more
  • Written informed consent from patient or authorized representative
Not Eligible

You will not qualify if you...

  • Existing stage III or higher pressure injury or skin necrosis at enrollment
  • Severe skin disease or peripheral vascular disease affecting skin or blood flow assessment
  • Inability to continuously monitor finger pulse oximetry (due to finger injury, amputation, or severe swelling)
  • Contraindications to fluid resuscitation such as acute heart failure with fluid overload
  • Expected survival less than 24 hours due to terminal illness
  • Participation in another interventional clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nantong First People's Hospital

Nantong, Jiangsu, China, 226000

Actively Recruiting

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Research Team

Y

Ying Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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