SepsisPPI-PROTECTNCT07367113
Peripheral Perfusion Index-guided Fluid Resuscitation for Preventing Acute Skin Failure in Elderly Critically Ill Patients
A study testing Peripheral Perfusion Index-guided Fluid Resuscitation Protocol and Conventional Goal-Directed Fluid Resuscitation in people with Sepsis and Septic Shock, run by Ying Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Acute Skin Failure
- What is being tested?
- Peripheral Perfusion Index-guided Fluid Resuscitation Protocol and Conventional Goal-Directed Fluid Resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nantong First People's Hospital
Nantong, Jiangsu, 226000
About this study
Official 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
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
- Sepsis, Septic Shock, Acute Skin Failure
- Being tested
- Peripheral Perfusion Index-guided Fluid Resuscitation Protocol, Conventional Goal-Directed Fluid Resuscitation
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Perfusion Index-guided Fluid Resuscitation ProtocolOther
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 ResuscitationOther
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 group | Role | What they receive |
|---|---|---|
| eripheral Perfusion Index-guided Fluid Resuscitation Protocol | Experimental | Not described Receives: Other: Peripheral Perfusion Index-guided Fluid Resuscitation Protocol |
| Conventional Fluid Resuscitation Group | Active comparator | Not described Receives: Other: Conventional Goal-Directed Fluid Resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission up to 7 days
Secondary outcomes (14)
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)
Measured: From ICU admission up to 7 days
Maximum Stage of Acute Skin Failure
The most severe stage of ASF (according to NPUAP/EPUAP 2014 criteria) observed within 7 days after ICU admission
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From ICU admission up to 7 days
Duration of Mechanical Ventilation
Total number of days requiring invasive mechanical ventilation during ICU stay
Measured: From ICU admission until ICU discharge, up to 90 days
Length of ICU Stay
Total number of days from ICU admission to ICU discharge
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From ICU admission until ICU discharge, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Nantong First People's Hospital
- Responsible party
- Sponsor-investigator, Ying Wang, Nantong First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367113
- Sponsor's protocol ID
- HAYY - 2025 - LW - 045
- Acronym
- PPI-PROTECT
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators may have further research, and the investigators may not consider releasing the research data until the results are announced
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07367113
- Acronym / sponsor ID
- PPI-PROTECT / HAYY - 2025 - LW - 045
- Conditions
- Sepsis, Septic Shock, Acute Skin Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Ying WangUniversity, hospital or other
- Collaborators
- Nantong First People's Hospital
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eripheral Perfusion Index-guided Fluid Resuscitation Protocol | Experimental | Other: Peripheral Perfusion Index-guided Fluid Resuscitation Protocol |
| Conventional Fluid Resuscitation Group | Active comparator | Other: Conventional Goal-Directed Fluid Resuscitation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral Perfusion Index-guided Fluid Resuscitation ProtocolIn 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. | Other | eripheral Perfusion Index-guided Fluid Resuscitation Protocol |
| Conventional Goal-Directed Fluid ResuscitationFluid 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. | Other | Conventional Fluid Resuscitation Group |
Primary outcome
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.
14 secondary outcomes
Time to Acute Skin Failure (ASF) Onset
Time frame: From ICU admission up to 7 days
Maximum Stage of Acute Skin Failure
Time frame: From ICU admission up to 7 days
Lactate Clearance Rate at 6 Hours
Time frame: Baseline and 6 hours after resuscitation initiation
Lactate Clearance Rate at 24 Hours
Time frame: Baseline and 24 hours after resuscitation initiation
Cumulative Fluid Balance at 72 Hours
Time frame: From ICU admission up to 72 hours
Incidence of Acute Kidney Injury
Time frame: From ICU admission up to 7 days
Duration of Mechanical Ventilation
Time frame: From ICU admission until ICU discharge, up to 90 days
Length of ICU Stay
Time frame: From ICU admission until ICU discharge, up to 90 days
28-Day All-Cause Mortality
Time frame: From ICU admission up to 28 days
90-Day All-Cause Mortality
Time frame: From ICU admission up to 90 days
Barthel Index at Hospital Discharge
Time frame: At hospital discharge, up to 90 days after ICU admission
Total Hospitalization Costs
Time frame: From hospital admission to hospital discharge, up to 90 days
30-Day Unplanned Readmission Rate
Time frame: 30 days after hospital discharge
Incidence of Resuscitation-Related Serious Adverse Events
Time frame: From ICU admission until ICU discharge, up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Perfusion Index-guided Fluid Resuscitation Protocol and Conventional Goal-Directed Fluid Resuscitation in people with Sepsis and Septic Shock, run by Ying Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Wang (+86 13485139816, wenquxingdiyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Skin Failure（per the NPUAP/EPUAP 2014 Guidelines） (time frame: From ICU admission up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.