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NCT Number: NCT03818269

Study of Subcutaneous Interstitial Pressure During Sepsis

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.

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Key information

Conditions

Patients with Septic Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de DIJON, Dijon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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®

Treatment and study plan

Subcutaneous pressure measurement

Procedure

Subcutaneous interstitial measurement at D1 and D2

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: PISEP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2019
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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