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NCT Number: NCT07367113

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

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.

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Key information

Conditions

Sepsis Acute Skin Failure Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantong First People's Hospital

Nantong, Jiangsu, 226000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 65 years.
  • Diagnosis of sepsis (according to Sepsis-3 criteria) or other types of shock requiring early and aggressive fluid resuscitation.
  • APACHE II score ≥ 15 at ICU admission.
  • Expected ICU length of stay ≥ 72 hours.
  • Written informed consent obtained from the patient or their legally authorized representative.

Exclusion criteria

  • Pre-existing stage III or higher pressure injury or skin necrosis at the time of enrollment.
  • Severe dermatological disease or peripheral vascular disease that could interfere with the assessment of skin or peripheral perfusion.
  • Inability to perform continuous finger pulse oximetry monitoring (e.g., due to bilateral finger injury, amputation, or severe peripheral edema).
  • Contraindications to liberal fluid resuscitation (e.g., acute cardiogenic pulmonary edema, severe heart failure with fluid overload).
  • Expected survival < 24 hours due to terminal illness or irreversible condition. Concurrent participation in another interventional clinical trial.

Treatment and study plan

Peripheral Perfusion Index-guided Fluid Resuscitation Protocol

Other

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

Other

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.

Primary outcomes

  1. Incidence of Acute Skin Failure（per the NPUAP/EPUAP 2014 Guidelines）

    Time frame: From ICU admission up to 7 days

    Proportion of patients who develop new-onset Acute Skin Failure (ASF) within 7 days after ICU admission. ASF is diagnosed and staged according to the NPUAP/EPUAP (2014) criteria.

Secondary outcomes

  1. Time to Acute Skin Failure (ASF) Onset

    Time frame: From ICU admission up to 7 days

    Number of days from ICU admission to the first diagnosis of ASF (assessed in patients who develop ASF)

  2. Maximum Stage of Acute Skin Failure

    Time frame: From ICU admission up to 7 days

    The most severe stage of ASF (according to NPUAP/EPUAP 2014 criteria) observed within 7 days after ICU admission

  3. Lactate Clearance Rate at 6 Hours

    Time frame: Baseline and 6 hours after resuscitation initiation

    Percentage decrease in serum lactate concentration from baseline to 6 hours after initiation of resuscitation

  4. Lactate Clearance Rate at 24 Hours

    Time frame: Baseline and 24 hours after resuscitation initiation

    Percentage decrease in serum lactate concentration from baseline to 24 hours after initiation of resuscitation

  5. Cumulative Fluid Balance at 72 Hours

    Time frame: From ICU admission up to 72 hours

    Net fluid balance (total fluid intake minus total output) calculated over the first 72 hours of ICU stay

  6. Incidence of Acute Kidney Injury

    Time frame: From ICU admission up to 7 days

    Proportion of patients who develop AKI according to KDIGO criteria within 7 days after ICU admission

  7. Duration of Mechanical Ventilation

    Time frame: From ICU admission until ICU discharge, up to 90 days

    Total number of days requiring invasive mechanical ventilation during ICU stay

  8. Length of ICU Stay

    Time frame: From ICU admission until ICU discharge, up to 90 days

    Total number of days from ICU admission to ICU discharge

  9. 28-Day All-Cause Mortality

    Time frame: From ICU admission up to 28 days

    Proportion of patients who die from any cause within 28 days after ICU admission

  10. 90-Day All-Cause Mortality

    Time frame: From ICU admission up to 90 days

    Proportion of patients who die from any cause within 90 days after ICU admission

  11. Barthel Index at Hospital Discharge

    Time frame: At hospital discharge, up to 90 days after ICU admission

    Score of the Barthel Index (a measure of activities of daily living) assessed at the time of hospital discharge in surviving patients. Range: 0-100, higher scores indicate greater independence

  12. Total Hospitalization Costs

    Time frame: From hospital admission to hospital discharge, up to 90 days

    Total direct medical costs incurred during the index hospitalization, expressed in local currency

  13. 30-Day Unplanned Readmission Rate

    Time frame: 30 days after hospital discharge

    Proportion of patients who have an unplanned readmission to any hospital within 30 days after hospital discharge

  14. Incidence of Resuscitation-Related Serious Adverse Events

    Time frame: From ICU admission until ICU discharge, up to 90 days

    Proportion of patients who experience serious adverse events related to fluid resuscitation (e.g., new-onset cardiogenic pulmonary edema, arrhythmia requiring intervention) during the ICU stay

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Wang

CONTACT

[email protected]

+86 13485139816

Sponsors and collaborators

Lead sponsor

Ying Wang

Other

Collaborators

  • Nantong First People's Hospital

Registry information

Official study title

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

Acronym: PPI-PROTECT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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