search
Back to results

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

Primary Purpose

Septic Shock

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Clonidine
Placebo
Sponsored by
Direction Centrale du Service de Santé des Armées
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Septic Shock focused on measuring pressor response, chronotropic response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Critical Care Unit, Hopital Desgenettes

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

clonidine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 19, 2013
Last Updated
July 26, 2017
Sponsor
Direction Centrale du Service de Santé des Armées
search

1. Study Identification

Unique Protocol Identification Number
NCT01856517
Brief Title
Upregulation of Alpha-1 Receptors Upon Septic Shock?
Acronym
CATACHOC
Official Title
Up Regulation of Alpha-1 Receptors Upon Septic Shock ?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Direction Centrale du Service de Santé des Armées

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
pressor response, chronotropic response

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
saline administration over 24 h following full optimization of patient according to current guidelines
Arm Title
clonidine
Arm Type
Active Comparator
Arm Description
clonidine 1 mcg.kg-1.h-1 over 24 h following full optimization of the patient according to current guidelines
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
change in pressor response to exogenous noradrenaline
Description
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.
Time Frame
0 and 24 h
Secondary Outcome Measure Information:
Title
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.
Time Frame
0 and 24 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Critical Care Unit, Hopital Desgenettes
City
Lyon
ZIP/Postal Code
69275
Country
France

12. IPD Sharing Statement

Learn more about this trial

Upregulation of Alpha-1 Receptors Upon Septic Shock?

We'll reach out to this number within 24 hrs