Effect of Hydrocortison on Post-ischemic Flow-mediated Di... | NCT01817153

ID	Type	Description	Link
2012-004736-39	EudraCT Number

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not enough recruitment

Expanded Access Info

Start Date

Nov 5, 2013Actual

Primary Completion Date

Nov 5, 2019Actual

Completion Date

Nov 5, 2019Actual

First Submitted Date

Mar 20, 2013

First Submission Date that Met QC Criteria

Mar 20, 2013

First Posted Date

Mar 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2020

Last Update Posted Date

Feb 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thierry BOULAIN, M.D., Centre Hospitalier Régional d'OrléansPrincipal Investigator

Lead Sponsor

Centre Hospitalier Régional d'OrléansOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

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

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).
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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	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
hydrocortison	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hydrocortison hemisuccinate	Drug		hydrocortison
placebo followed by hydrocortisone hemisuccinate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vasoreactivity		every 6 hours over the first 24 hours of intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thierry Boulain, MD	Centre Hospitalier Régional d'Orléans, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Régional d'Orléans		Orléans		45000	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012769	Shock