Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
133 participants
INTERVENTIONAL
2021-05-21
2022-11-03
Brief Summary
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Additionally, the project has a small number of subjects that will participate in a clinical trial in which they would self-select to receive one dose of hydrocortisone intravenously while they are in the hospital. This pilot of up to 20 participants in the trial arm is designed to create a first indication of whether this could become an effective early intervention to prevent PTSD if given while trauma memories are first being formed.
This registration will list the observational part (number of participants =100) as well as the clinical trial (number of participants =20).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intravenous hydrocortisone
Intravenous (IV) hydrocortisone
Participants (20) will be given IV hydrocortisone within 6-12 hours of the traumatic event.
90 - 150 mg. of intravenous hydrocortisone dosing regimen based on participant weight: 90mg will be administrated to participants weighing 45-59kg. 100mg will be administrated to participants weighing 60-69kg. 120mg will be administrated to participants weighing 70-89kg. 140mg will be administrated to participants weighing 90-99kg. 150mg will be administrated to participants weighing 100-120kg.
Observational
Participants will complete assessments/surveys only.
No interventions assigned to this group
Interventions
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Intravenous (IV) hydrocortisone
Participants (20) will be given IV hydrocortisone within 6-12 hours of the traumatic event.
90 - 150 mg. of intravenous hydrocortisone dosing regimen based on participant weight: 90mg will be administrated to participants weighing 45-59kg. 100mg will be administrated to participants weighing 60-69kg. 120mg will be administrated to participants weighing 70-89kg. 140mg will be administrated to participants weighing 90-99kg. 150mg will be administrated to participants weighing 100-120kg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postpartum hemorrhage or emergency cesarean delivery
* Owner of a smart phone or email account
Exclusion Criteria
* Psychiatric consult during admission, or need for hospital appointed sitter during admission
* Non-English speakers requiring a translator
* Current corticosteroid use or corticosteroid use during the study period (including betamethasone for promoting fetal lung maturity)
* Cognitive impairment identified by medical chart review or patients requiring a legal guardian for medical decision making
* Self-reported hypersensitivity to hydrocortisone
* Inability to consent patient and administer study drug within 12 hours of a traumatic event
* Weight \< 45 kilograms (kg) or \>120kg
* Subjects with systemic active infections (e.g. viral, bacterial, fungal, protozoan, or helminthic)
* Subjects with uncontrolled hypertension, renal insufficiency, or decompensated congestive heart failure
* Subjects with inflammatory bowel disease
* Subjects with active or latent peptic ulcers
18 Years
FEMALE
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Joanna Kountanis
Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology
Principal Investigators
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Joanna A Kountanis, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology
Locations
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Michigan Medicine - University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00174658
Identifier Type: -
Identifier Source: org_study_id
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