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Clinical Trials in China / NCT07367113
Recruiting Not applicable

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

NCT07367113 · tracked via the Priya Life Science China tracker
Sponsor
Ying Wang
Phase
Not applicable
Started
2025-01-01
Last updated
2026-04-09

Condition(s) studied

SepsisSeptic ShockAcute Skin Failure

Investigational drug(s) / intervention(s)

Peripheral Perfusion Index-guided Fluid Resuscitation ProtocolConventional Goal-Directed Fluid Resuscitation

Peripheral Perfusion Index-guided Fluid Resuscitation Protocol: 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 Resuscitation: 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.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nantong First People's Hospital Nantong Jiangsu Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07367113 on ClinicalTrials.gov ↗ ← All trials in China