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Effect of Hydrocortison on Post-ischemic Flow-mediated Dilation and on Thenar Oxygen Saturation in Human Septic Shock. (HyStOON)

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ClinicalTrials.gov Identifier: NCT01817153
Recruitment Status : Recruiting
First Posted : March 22, 2013
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Thierry BOULAIN, Centre Hospitalier Régional d'Orléans

Brief Summary:
The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by near-infrared spectroscopy).

Condition or disease Intervention/treatment Phase
Septic Shock Adult Drug: hydrocortison hemisuccinate Drug: placebo followed by hydrocortisone hemisuccinate Phase 2 Phase 3

Detailed Description:

Two primary end points, considered as reflecting vasoreactivity will be assessed :

  1. Flow-mediated dilation (FMD) of the brachial artery, measured by ultrasound imaging, expressed in mm or in percentage, will be calculated from artery diameters measured before and after a vascular occlusion test (cuff around arm or forearm).
  2. recovery slope of thenar oxygen saturation (StO2), assessed by near infrared spectroscopy (NIRS), expressed in %/second, will be recorded after the vascular occlusion test.

The two primary end points (FMD and recovery slope of StO2)will be assessed at the following timepoints :

  • baseline (before first injection of placebo or hydrocortison)
  • 2 hours after first injection of placebo or hydrocortison
  • 2 hours after second injection of placebo or hydrocortison (i.e. 8 hours after first injection)
  • 4 to 6 hours after third injection
  • 4 to 6 hours after fourth injection (optional)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Hydrocortison on Post-ischemic Brachial Artery Dilation and on Thenar Oxygen Saturation in Adult Septic Shock. A Human Placebo-controlled Randomized Study.
Study Start Date : November 2013
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Placebo Comparator: placebo
10 mL normal saline iv at H0 and H6 (2 first injections blinded), followed by hydrocortison (open label) 50 mg iv at H8, H14 and H20
Drug: placebo followed by hydrocortisone hemisuccinate
Active Comparator: hydrocortison
50 mg hydrocortison iv at H0 and H6 (2 first injections blinded), followed by hydrocortison (open label) 50 mg iv at H12, H18 and H24
Drug: hydrocortison hemisuccinate



Primary Outcome Measures :
  1. Vasoreactivity [ Time Frame: every 6 hours over the first 24 hours of intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age over 18 yrs
  • consent obtained
  • septic shock (according to international definition)
  • patient sedated and submitted to invasive mechanical ventilation
  • no need for surgery expected within 24 hours after enrollment
  • patient has received at least one dose of large spectrum antibiotics
  • superior vena cava catheter in place
  • patient carrying a thermodilution device for cardiac output measurement
  • stable mean arterial pressure within 65-5 mmHg limits for at least 2 hours;

Exclusion Criteria:

  • pregnancy
  • age below 18 years
  • patient treated with iv continuous epinephrine
  • chronic occlusive arteriopathy of the upper limbs
  • regular or recent treatment with glibenclamide or glipizide
  • regular or recent treatment with steroids
  • known surrenal insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817153


Contacts
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Contact: Thierry Boulain, MD thierry.boulain@chr-orleans.fr
Contact: Johann Le Drogoff johann.le-drogoff@chr-orleans.fr

Locations
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France
Centre Hospitalier Régional d'Orléans Recruiting
Orléans, France, 45000
Contact: Thierry Boulain, MD         
Contact: Johann Le Drogoff         
Principal Investigator: Thierry Boulain, MD         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Thierry Boulain, MD Centre Hospitalier Régional d'Orléans, France

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Responsible Party: Thierry BOULAIN, M.D., Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT01817153     History of Changes
Other Study ID Numbers: CHRO-2012-04
2012-004736-39 ( EudraCT Number )
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: September 2016

Additional relevant MeSH terms:
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Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents