Status:
UNKNOWN
Comparison of Extubation Delay After Prolonged Sedation
Lead Sponsor:
University Hospital, Rouen
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This monocentric, prospective, controlled, randomized, single-blind study will be conducted in surgical resuscitation at the Rouen University Hospital. The aim of our research project is to evaluate t...
Detailed Description
In intensive care, sedation of patients is frequently used for their management. Combined with analgesia, it provides the comfort essential for the implementation of certain therapies such as mechanic...
Eligibility Criteria
Inclusion
- Major patients,
- Sedated with midazolam and sufentanil for a maximum of 3 days and ventilated invasively,
- Presenting a duration of sedation and invasive ventilation expected after inclusion between 3 days and 10 days,
- Presenting septic shock according to the SEPSIS-3 definition with the following 4 criteria :
- Clinical suspicion of infection or positive microbiological sample if applicable,
- Organ Failure: SOFA (Sepsis-related Organ Failure Assessment) ≥ 2 (Annex n°5),
- Need for vasoactive amines to maintain sufficient organ perfusion pressure,
- Arterial lactate \> 2mmol/l,
- Stabilized septic shock without the need to increase noradrenaline doses over the last 6 hours,
- For women, absence of current pregnancy: negative pregnancy test,
- Subjects affiliated to a social security system.
- If the patient is unable to sign the consent (emergency situation) the consent will be signed by his or her representative ((1) the trusted person, or failing that, (2) a family member, or (3) a relative of the person concerned). In this case, the patient will subsequently be asked for consent to continue the study.
Exclusion
- Refusal of the patient to continue the study after waking up,
- Duration of sedation after randomization less than 3 days or more than 10 days.
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04710914
Start Date
December 15 2020
End Date
March 31 2023
Last Update
January 15 2021
Active Locations (1)
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1
Rouen University Hospital
Rouen, France, 760031