Septic ShockPhase 4NCT00842933
Adrenal Insufficiency in Septic Shock
A Phase 4 study testing Corticosteroid in people with Septic Shock and Acute Adrenal Insufficiency, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Acute Adrenal Insufficiency
- What is being tested?
- Corticosteroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
- Conditions
- Septic Shock, Acute Adrenal Insufficiency
- Being tested
- Corticosteroid
- Keywords
- Septic shock, Acute adrenal insufficiency
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
Also called corticosteroids,prednisone,methylpredisolone,hydrocortisone
Cessation of corticosteroids 24 hours after cessation of vasopressors
CorticosteroidDrug
Also called prednisone,methylprednisolone,corticosteroid,hydrocortisone
Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first. Receives: Drug: Corticosteroid |
| Standard of care group | Active comparator | Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock. Receives: Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure for this study is the number of hours receiving steroid dosing.
Measured: 7 days
Secondary outcomes (1)
A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU.
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startMay 2007
- Primary completionMay 2010
- Study completionMay 2011
Why it stopped: Unable to meet enrollment goal prior to PI transfer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Laura J Moore, MD, Principal investigator, The Methodist Hospital, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842933
- Sponsor's protocol ID
- 0207-0012
- Status last verified
- Jun 2011
- First submitted
- 11 Feb 2009
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00842933
- Acronym / sponsor ID
- 0207-0012
- Conditions
- Septic Shock, Acute Adrenal Insufficiency
- Keywords
- Septic shock, Acute adrenal insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet enrollment goal prior to PI transfer
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: CorticosteroidCorticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first. |
| Standard of care group | Active comparator | Drug: CorticosteroidStandard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorticosteroidAlso: corticosteroids,prednisone,methylpredisolone,hydrocortisoneCessation of corticosteroids 24 hours after cessation of vasopressors | Drug | Experimental group |
| CorticosteroidAlso: prednisone,methylprednisolone,corticosteroid,hydrocortisoneAdminister daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock | Drug | Standard of care group |
Primary outcome
The primary outcome measure for this study is the number of hours receiving steroid dosing.
Time frame: 7 days
1 secondary outcome
A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU.
Time frame: up to 28 days
Results and safety
The study was stopped early (reason given: Unable to meet enrollment goal prior to PI transfer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura J Moore, MD principal investigator
The Methodist Hospital, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corticosteroid in people with Septic Shock and Acute Adrenal Insufficiency, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to meet enrollment goal prior to PI transfer). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure for this study is the number of hours receiving steroid dosing. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.