Study of Subcutaneous Interstitial Pressure During Sepsis

Patients With Septic Shock Clinical Trial

— PISEP  

Official title:

Study of Subcutaneous Interstitial Pressure During Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818269
• Other study ID #: DARGENT 2018
• Status: Completed
• Phase: N/A
• Start date: May 26, 2019
• Est. completion date: August 9, 2022

Study information

• Verified date: September 2021
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 9, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Patients With Septic Shock
• Shock, Septic

Intervention

Procedure:
• Subcutaneous pressure measurement
Subcutaneous interstitial measurement at D1 and D2

Locations

Country	Name	City	State
France	CHU de DIJON	Dijon
France	HCL - Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of Initial subcutaneous interstitial pressure	Measure the difference between the subcutaneous interstitial pressure of patients in septic shock compared to patients without sepsis	Day 0