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

Phase 2

Terminated

• Conditions: Adult; Septic Shock
• Interventions: Drug: placebo followed by hydrocortisone hemisuccinate; Drug: hydrocortison hemisuccinate

• Registration Number: NCT01817153
• Lead Sponsor: 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).

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)

Study Timeline

• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-22
• Study Start: 2013-11-05
• Primary Completion: 2019-11-05
• Study Completion: 2019-11-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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;

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo followed by hydrocortisone hemisuccinate	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
hydrocortison	hydrocortison hemisuccinate	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

Primary Outcome Measures

Name	Time	Method
Vasoreactivity	every 6 hours over the first 24 hours of intervention

Trial Locations

Locations (1)

Centre Hospitalier Régional d'Orléans; 🇫🇷 Orléans, France