Adrenal Insufficiency in Septic Shock

Study Overview
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Brief Summary
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Randomized controlled trial evaluating the duration of steroid replacement therapy in patients with adrenal insufficiency and septic shock. Patients will be randomized to receive either hydrocortisone 50 mg IV every six hours for seven days (control) or hydrocortisone 50 mg IV every six hours until 24 hours after achievement of hemodynamic stability (MAP > 65 mm Hg off of vasopressors).

Official Title
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An Open-label, Prospective, Randomized, Controlled Clinical Trial of the Use of Reduced Duration Versus Standard Duration Steroid Replacement Therapy for Acute Adrenal Insufficiency in Patients With Septic Shock

Conditions
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Septic Shock, Acute Adrenal Insufficiency

Intervention / Treatment
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* Drug: Corticosteroid
* Drug: Corticosteroid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are 18 years of age or older Patients who sign informed consent or are represented by a legally authorized representative to provide consent on behalf of the patient Patients with septic shock meeting the ACCM/SCCM consensus conference definitions for septic shock Exclusion Criteria: Patients with documented allergic or anaphylactic reactions to corticosteroids Patients who have received steroid therapy within 6 months of presentation Patients who have received steroids during their hospital admission, with the exception of a single dose of dexamethasone Patients who have received etomidate in the preceding 12 hours Patients who have had a prior adrenalectomy or a known history of adrenal disease (documented adrenal insufficiency or Cushing syndrome). Documented Human Immunodeficiency Virus (HIV) infection Pregnancy Allergies to adrenocorticotropic hormone (ACTH) or corticosteroids Administration of additional medications which may suppress the hypothalamic-pituitary axis: Ketoconazole Aminoglutethimide Mitotane Megestrol acetate Suramin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first. | Drug: Corticosteroid<br>* Cessation of corticosteroids 24 hours after cessation of vasopressors<br>* Other names: corticosteroids,prednisone,methylpredisolone,hydrocortisone;|
| Active Comparator: Standard of care group<br>Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock. | Drug: Corticosteroid<br>* Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock<br>* Other names: prednisone,methylprednisolone,corticosteroid,hydrocortisone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure for this study is the number of hours receiving steroid dosing. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU. |  | up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Septic shock, Acute adrenal insufficiency