Upregulation of Alpha-1 Receptors Upon Septic Shock? (CATACHOC)

Direction Centrale du Service de Santé des Armées

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Septic Shock

Treatments: Drug: Placebo; Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01856517

2011PPRC01TURC

Details and patient eligibility

About

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 will be, the lower the pressor response to exogenous noradrenaline will be. This will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

saline administration over 24 h following full optimization of patient according to current guidelines

Treatment:

Drug: Placebo

clonidine

Active Comparator group

Description:

clonidine 1 mcg.kg-1.h-1 over 24 h following full optimization of the patient according to current guidelines

Treatment:

Drug: Clonidine