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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

• Incidence of Acute Skin Failure（per the NPUAP/EPUAP 2014 Guidelines） [Срок оценки: From ICU admission up to 7 days]

Вторичные конечные точки (12)

• Time to Acute Skin Failure (ASF) Onset [Срок оценки: From ICU admission up to 7 days]
• Maximum Stage of Acute Skin Failure [Срок оценки: From ICU admission up to 7 days]
• Lactate Clearance Rate at 6 Hours [Срок оценки: Baseline and 6 hours after resuscitation initiation]
• Lactate Clearance Rate at 24 Hours [Срок оценки: Baseline and 24 hours after resuscitation initiation]
• Cumulative Fluid Balance at 72 Hours [Срок оценки: From ICU admission up to 72 hours]
• Incidence of Acute Kidney Injury [Срок оценки: From ICU admission up to 7 days]
• Duration of Mechanical Ventilation [Срок оценки: From ICU admission until ICU discharge, up to 90 days]
• Length of ICU Stay [Срок оценки: From ICU admission until ICU discharge, up to 90 days]
• 28-Day All-Cause Mortality [Срок оценки: From ICU admission up to 28 days]
• 90-Day All-Cause Mortality [Срок оценки: From ICU admission up to 90 days]
• Barthel Index at Hospital Discharge [Срок оценки: At hospital discharge, up to 90 days after ICU admission]
• Total Hospitalization Costs [Срок оценки: From hospital admission to hospital discharge, up to 90 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nantong First People's Hospital — Nantong

Идентификаторы

NCT: NCT07367113 · HAYY - 2025 - LW - 045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗