Status:
TERMINATED
Upregulation of Alpha-1 Receptors Upon Septic Shock?
Lead Sponsor:
Direction Centrale du Service de Santé des Armées
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline w...
Eligibility Criteria
Inclusion
- patients presenting to the CCU with septic shock : SBP\<90 mm Hg refractory to volume load (\>30 ml.kg-1 within 6 h before inclusion) thus in need administration of noradrenaline for \>1 h (0.1 mcg.kg-1.h-1 i.e. \>0.5 mg.h-1/70 kg) to maintain mean BP\>65 mm Hg.
- criteria for sepsis :temperature\>38.5 or \<36°C ; WBC\>12 000 or \<4000/ml ; tachypnea (\>20 cycles par min) or mechanical ventilation ; tachycardia : \>90 bpmin
- written informed consent by the patient or next of kin or signature by the investigators of the form "emergency inclusion"
Exclusion
- age\<18 ans
- pregnancy
- mental illness making informed consent impossible
- Absence of consent as signed by the patient or next of kin or signature of "emergency inclusion form"
- individual without social security coverage or participating in another biomedical research
- Contre-indications to clonidine (uncorrected hypovolemia, sick sinus syndrom, III grade AV block)
- HR\<70 bp/min
- pre-exitus
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01856517
Start Date
August 1 2013
End Date
September 1 2014
Last Update
July 28 2017
Active Locations (1)
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1
Critical Care Unit, Hopital Desgenettes
Lyon, France, 69275