Status:
COMPLETED
Study of Subcutaneous Interstitial Pressure During Sepsis
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Patients with Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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®
Key Trial Info
Start Date :
May 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03818269
Start Date
May 26 2019
End Date
August 9 2022
Last Update
October 23 2024
Active Locations (2)
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1
CHU de DIJON
Dijon, France, 21079
2
HCL - Hôpital Edouard Herriot
Lyon, France, 69003