Study of Subcutaneous Interstitial Pressure During Sepsis (PISEP)

  • End date
    Dec 9, 2023
  • participants needed
  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 9 February 2022


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.

Condition Patients With Septic Shock
Treatment Subcutaneous pressure measurement
Clinical Study IdentifierNCT03818269
SponsorCentre Hospitalier Universitaire Dijon
Last Modified on9 February 2022


Yes No Not Sure

Inclusion Criteria

Criteria common to both groups
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
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

Exclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note