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Study of Subcutaneous Interstitial Pressure During Sepsis (PISEP)

Primary Purpose

Patients With Septic Shock

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Subcutaneous pressure measurement
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Patients With Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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®

Sites / Locations

  • CHU de DIJON
  • HCL - Hôpital Edouard Herriot

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Septic shock

Control

Arm Description

Outcomes

Primary Outcome Measures

Value of Initial subcutaneous interstitial pressure
Measure the difference between the subcutaneous interstitial pressure of patients in septic shock compared to patients without sepsis

Secondary Outcome Measures

Full Information

First Posted
January 21, 2019
Last Updated
November 29, 2022
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT03818269
Brief Title
Study of Subcutaneous Interstitial Pressure During Sepsis
Acronym
PISEP
Official Title
Study of Subcutaneous Interstitial Pressure During Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 26, 2019 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
August 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Septic Shock

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Septic shock
Arm Type
Other
Arm Title
Control
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Subcutaneous pressure measurement
Intervention Description
Subcutaneous interstitial measurement at D1 and D2
Primary Outcome Measure Information:
Title
Value of Initial subcutaneous interstitial pressure
Description
Measure the difference between the subcutaneous interstitial pressure of patients in septic shock compared to patients without sepsis
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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®
Facility Information:
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
HCL - Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

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Study of Subcutaneous Interstitial Pressure During Sepsis

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