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

NCT01817153 | Terminated Phase 2

• 2 other identifiers: CHRO-2012-042012-004736-39
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Septic Shock; Adult

Outcome Measures

Primary Outcomes (1)

• Vasoreactivity

  every 6 hours over the first 24 hours of intervention

Study Arms (2)

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

hydrocortison hemisuccinate DRUG

hydrocortison

placebo followed by hydrocortisone hemisuccinate DRUG

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Régional d'Orléans

Orléans, 45000, France

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Thierry Boulain, MD

  Centre Hospitalier Régional d'Orléans, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: November 5, 2013
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

FR (1)