Upregulation of Alpha-1 Receptors Upon Septic Shock?

Septic Shock Clinical Trial

— CATACHOC  

Official title:

Up Regulation of Alpha-1 Receptors Upon Septic Shock ?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01856517
• Other study ID #: 2011PPRC01TURC
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 19, 2013
• Last updated: July 26, 2017
• Start date: August 2013
• Est. completion date: September 2014

Study information

• Verified date: July 2017
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Clonidine

• Placebo

Locations

Country	Name	City	State
France	Critical Care Unit, Hopital Desgenettes	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in pressor response to exogenous noradrenaline	bolus of exogenous noradrenaline (1 mcg and up) are administered to the patient to evoke an increase in delta systolic blood pressure by 25-30 mm Hg. Administration of increasing dose of noradrenaline is stopped as soon as delta systolic blood pressure has reached 25-30 mm Hg.	0 and 24 h
Secondary	change in heart rate response to increasing doses of dobutamine (100 mcg and up) to evoke an increase in heart rate up to 20 beats per min.		0 and 24 h