Patients With Septic ShockPISEPNCT03818269
Study of Subcutaneous Interstitial Pressure During Sepsis
A study testing Subcutaneous pressure measurement in people with Patients With Septic Shock, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
The pathophysiology of sepsis is characterized by the sudden onset of vasodilation and vascular permeability with capillary leakage. This leakage contributes to the development of generalized edema which is not clinically detectable below 4 litres but which becomes visible after a few days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Septic Shock
- What is being tested?
- Subcutaneous pressure measurement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesFrance
- Study dates
- 26 May 2019to 9 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria common to both groups:
- Adult,
- Admitted within the last 24 hours in intensive care,
- Under mechanical ventilation with orotracheal intubation,
- Without clinically detectable edema (in any area)
- Patient and/or guardian and/or close relative has given written consent
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- Patients included in the "septic shock" arm:
- Diagnosis of septic shock as defined by the "Sepsis-3" Consensus Conference (JAMA 2016) (34): documented or highly suspected infection with SOFA ≥ 2, persistent hypotension after correction of hypovolemia requiring vasopressor administration, and serum lactate > 2 mmol/l.
- Vascular filling < 50 ml/kg
- Patients included in the control arm:
- Absence of sepsis and shock from any cause:
- PAS > 100 mmHg
- Absence of vasopressors
- Preserved urine > 0.5 ml/kg/h
- Normal serum lactate
- Crystalloid infusions < 50ml/kg over the previous 12 hours
Who cannot join
- not affiliated to national health insurance
- under court protection
- pregnant or breastfeeding
- Clinical disseminated intravascular coagulation (DIC) with hemorrhagic syndrome
- Admitted after resuscitation for cardiac arrest
- Presenting cardiogenic shock
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- Presenting acute pancreatitis
- Severe overall dehydration (clinical signs of dehydration and natremia > 150mmol/l)
- Presenting metformin intoxication
- In severe sepsis or septic shock for more than 24 hours,
- Dying or for whom death seems imminent (within 24 hours),
- Hypersensitivity to lidocaine and/or prilocaine or local anesthetics of the amide type or to any of the excipients of EMLAPATCH®
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de DIJON
Dijon, 21079
HCL - Hôpital Edouard Herriot
Lyon, 69003
About this study
The pathophysiology of sepsis is characterized by the sudden onset of vasodilation and vascular permeability with capillary leakage. This leakage contributes to the development of generalized edema which is not clinically detectable below 4 litres but which becomes visible after a few days. The edema accumulates mainly at the subcutaneous level due to the high compliance of this tissue. Edema, and therefore hydrosodium overload, testifies to the severity of the inflammation. However, it could also be harmful in itself (affecting microcirculation and increasing mortality) as suggested by numerous clinical and experimental studies.
The transfer of fluids between vascular and interstitial compartments during sepsis therefore has a central role in the pathophysiology of the disease and associated mortality. These transfers are mainly controlled at the microvascular level (with constant permeability) by the difference between capillary (CP) and interstitial (IP) pressures. In healthy subjects, subcutaneous IP is discreetly negative (-1 mmHg) and varies very little. On the other hand, a sometimes drastic decrease in IP has been described in various localized and systemic inflammatory situations. These pressure variations may be explained by the collagen structure of the interstitial tissue and a change in the three-dimensional conformation of these macromolecules induced by inflammation mediators. In an animal model of sepsis, a study showed significantly lower pressure in a group of animals in endotoxic shock. IP has never been measured in humans during sepsis. The objective of this study is to analyze subcutaneous IP (SCIP) in patients with septic shock compared with controls in order to evaluate the direct role of interstitial tissue in the onset of edema during sepsis.
- Conditions
- Patients With Septic Shock
- Being tested
- Subcutaneous pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous pressure measurementProcedure or surgery
Subcutaneous interstitial measurement at D1 and D2
| Study group | Role | What they receive |
|---|---|---|
| Septic shock | Other | Not described Receives: Procedure: Subcutaneous pressure measurement |
| Control | Other | Not described Receives: Procedure: Subcutaneous pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of Initial subcutaneous interstitial pressure
Measure the difference between the subcutaneous interstitial pressure of patients in septic shock compared to patients without sepsis
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start26 May 2019
- Primary completion21 Jul 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Septic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818269
- Sponsor's protocol ID
- DARGENT 2018
- Acronym
- PISEP
- Status last verified
- Sep 2021
- First submitted
- 21 Jan 2019
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dargent A, Fournel I, Jacquier M, Dumargne H, Argaud L, Quenot JP. Subcutaneous interstitial pressure measurement during early septic shock: an exploratory study. Sci Rep. 2025 Aug 27;15(1):31554. doi: 10.1038/s41598-025-15813-z.
PubMed 40866441
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Subcutaneous Interstitial Pressure During Sepsis
- ClinicalTrials.gov ID
- NCT03818269
- Acronym / sponsor ID
- PISEP / DARGENT 2018
- Conditions
- Patients With Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 26 May 2019 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 28 Jan 2019 (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.
The pathophysiology of sepsis is characterized by the sudden onset of vasodilation and vascular permeability with capillary leakage. This leakage contributes to the development of generalized edema which is not clinically detectable below 4 litres but which becomes visible after a few days. The edema accumulates mainly at the subcutaneous level due to the high compliance of this tissue. Edema, and therefore hydrosodium overload, testifies to the severity of the inflammation. However, it could also be harmful in itself (affecting microcirculation and increasing mortality) as suggested by numerous clinical and experimental studies.
The transfer of fluids between vascular and interstitial compartments during sepsis therefore has a central role in the pathophysiology of the disease and associated mortality. These transfers are mainly controlled at the microvascular level (with constant permeability) by the difference between capillary (CP) and interstitial (IP) pressures. In healthy subjects, subcutaneous IP is discreetly negative (-1 mmHg) and varies very little. On the other hand, a sometimes drastic decrease in IP has been described in various localized and systemic inflammatory situations. These pressure variations may be explained by the collagen structure of the interstitial tissue and a change in the three-dimensional conformation of these macromolecules induced by inflammation mediators. In an animal model of sepsis, a study showed significantly lower pressure in a group of animals in endotoxic shock. IP has never been measured in humans during sepsis. The objective of this study is to analyze subcutaneous IP (SCIP) in patients with septic shock compared with controls in order to evaluate the direct role of interstitial tissue in the onset of edema during sepsis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic shock | Other | Procedure: Subcutaneous pressure measurement |
| Control | Other | Procedure: Subcutaneous pressure measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adult,
- Admitted within the last 24 hours in intensive care,
- Under mechanical ventilation with orotracheal intubation,
- Without clinically detectable edema (in any area)
- Patient and/or guardian and/or close relative has given written consent
Key exclusion criteria (12 listed)
- not affiliated to national health insurance
- under court protection
- pregnant or breastfeeding
- Clinical disseminated intravascular coagulation (DIC) with hemorrhagic syndrome
- Admitted after resuscitation for cardiac arrest
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 |
|---|---|---|
| Subcutaneous pressure measurementSubcutaneous interstitial measurement at D1 and D2 | Procedure or surgery | Control, Septic shock |
Primary outcome
Value of Initial subcutaneous interstitial pressure
Time frame: Day 0
Measure the difference between the subcutaneous interstitial pressure of patients in septic shock compared to patients without sepsis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Results publication: PubMed 40866441Dargent A, Fournel I, Jacquier M, Dumargne H, Argaud L, Quenot JP. Subcutaneous interstitial pressure measurement during early septic shock: an exploratory study. Sci Rep. 2025 Aug 27;15(1):31554. doi: 10.1038/s41598-025-15813-z.
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Septic Shock
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous pressure measurement in people with Patients With Septic Shock, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
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 16 inclusion and 12 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: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of Initial subcutaneous interstitial pressure (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03818269, which also lists 1 linked publication.
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 1 Oct 2026.