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| Name | Class |
|---|---|
| Nantong First People's Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eripheral Perfusion Index-guided Fluid Resuscitation Protocol | Experimental |
| |
| Conventional Fluid Resuscitation Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute Skin Failure（per the NPUAP/EPUAP 2014 Guidelines） | 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. | From ICU admission up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Acute Skin Failure (ASF) Onset | Number of days from ICU admission to the first diagnosis of ASF (assessed in patients who develop ASF) | From ICU admission up to 7 days |
| Maximum Stage of Acute Skin Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Wang | Contact | +86 13485139816 | wenquxingdiyi@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantong First People's Hospital | Recruiting | Nantong | Jiangsu | 226000 | China |
The investigators may have further research, and the investigators may not consider releasing the research data until the results are announced
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| 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. |
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The most severe stage of ASF (according to NPUAP/EPUAP 2014 criteria) observed within 7 days after ICU admission
| From ICU admission up to 7 days |
| Lactate Clearance Rate at 6 Hours | Percentage decrease in serum lactate concentration from baseline to 6 hours after initiation of resuscitation | Baseline and 6 hours after resuscitation initiation |
| Lactate Clearance Rate at 24 Hours | Percentage decrease in serum lactate concentration from baseline to 24 hours after initiation of resuscitation | Baseline and 24 hours after resuscitation initiation |
| Cumulative Fluid Balance at 72 Hours | Net fluid balance (total fluid intake minus total output) calculated over the first 72 hours of ICU stay | From ICU admission up to 72 hours |
| Incidence of Acute Kidney Injury | Proportion of patients who develop AKI according to KDIGO criteria within 7 days after ICU admission | From ICU admission up to 7 days |
| Duration of Mechanical Ventilation | Total number of days requiring invasive mechanical ventilation during ICU stay | From ICU admission until ICU discharge, up to 90 days |
| Length of ICU Stay | Total number of days from ICU admission to ICU discharge | From ICU admission until ICU discharge, up to 90 days |
| 28-Day All-Cause Mortality | Proportion of patients who die from any cause within 28 days after ICU admission | From ICU admission up to 28 days |
| 90-Day All-Cause Mortality | Proportion of patients who die from any cause within 90 days after ICU admission | From ICU admission up to 90 days |
| Barthel Index at Hospital Discharge | 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 | At hospital discharge, up to 90 days after ICU admission |
| Total Hospitalization Costs | Total direct medical costs incurred during the index hospitalization, expressed in local currency | From hospital admission to hospital discharge, up to 90 days |
| 30-Day Unplanned Readmission Rate | Proportion of patients who have an unplanned readmission to any hospital within 30 days after hospital discharge | 30 days after hospital discharge |
| Incidence of Resuscitation-Related Serious Adverse Events | 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 | From ICU admission until ICU discharge, up to 90 days |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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