Adrenocortical DeficiencyPhase 4NCT01792037
Single Dose of Etomidate and Adrenal Cortex
A Phase 4 study testing Etomidate, Midazolam and methylprednisolone in people with Adrenocortical Deficiency and Hemodynamic Instability, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
we aim to evaluate the effects of single dose of etomidate or use of steroid prior to etomidate during emergency intubation on hemodynamics and adrenal cortex. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Adrenocortical Deficiency, Hemodynamic Instability
- What is being tested?
- Etomidate, Midazolam and methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2012to Mar 2013
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 25-65 years old with American Society of Anesthesiology scores III or IV that have applied to emergency department and receives an indication for intubation by the intensive care unit physicians will be included to the study
Who cannot join
- Patients using steroid prior to the intubation and/or patients with chronical inflammatory diseases will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Istanbul, Fatih, 34400
About this study
Official title: the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial
we aim to evaluate the effects of single dose of etomidate or use of steroid prior to etomidate during emergency intubation on hemodynamics and adrenal cortex.
- Conditions
- Adrenocortical Deficiency, Hemodynamic Instability
- Being tested
- Etomidate, Midazolam, methylprednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Also called etomidate lipuro, BRAUN
MidazolamDrug
Also called Dormicum,Roche
Also called Prednol-L, Mustafa Nevzat
| Study group | Role | What they receive |
|---|---|---|
| Etomidate | Active comparator | After taking of the blood samples, patients in Group I will be intubated with 0.3 mg/kg etomidate iv. Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired. Receives: Drug: Etomidate |
| etomidate, steroid | Active comparator | After taking of the blood samples, patients in Group II will be intubated with 0.3 mg/kg etomidate iv following a 2mg/kg methylprednisolone iv Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired. Receives: Drug: Etomidate; Drug: methylprednisolone |
| midazolam | Active comparator | After taking of the blood samples, patients in Group III will be intubated with 0.01 mg/kg midazolam iv. Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.
Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of use of steroid on adrenal cortex prior to single dose etomidate by comparing cortisol levels
Measured: 24 hours
Secondary outcomes (1)
compare effects of midazolam and etomidate on systemic blood pressure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenocortical DeficiencyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
- Investigators
- Fatis Altindas, Prof., Study director, Chairman of the Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792037
- Sponsor's protocol ID
- 26177
- Status last verified
- Feb 2013
- First submitted
- 12 Feb 2013
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tekwani KL, Watts HF, Sweis RT, Rzechula KH, Kulstad EB. A comparison of the effects of etomidate and midazolam on hospital length of stay in patients with suspected sepsis: a prospective, randomized study. Ann Emerg Med. 2010 Nov;56(5):481-9. doi: 10.1016/j.annemergmed.2010.05.034. Epub 2010 Sep 15.
PubMed 20828877
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01792037
- Acronym / sponsor ID
- 26177
- Conditions
- Adrenocortical Deficiency, Hemodynamic Instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Feb 2013 (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.
we aim to evaluate the effects of single dose of etomidate or use of steroid prior to etomidate during emergency intubation on hemodynamics and adrenal cortex.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Etomidate | Active comparator | Drug: EtomidateAfter taking of the blood samples, patients in Group I will be intubated with 0.3 mg/kg etomidate iv. Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired. |
| etomidate, steroid | Active comparator | Drug: Etomidate, Drug: methylprednisoloneAfter taking of the blood samples, patients in Group II will be intubated with 0.3 mg/kg etomidate iv following a 2mg/kg methylprednisolone iv Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired. |
| midazolam | Active comparator | Drug: MidazolamAfter taking of the blood samples, patients in Group III will be intubated with 0.01 mg/kg midazolam iv. Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery. Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between 25-65 years old with American Society of Anesthesiology scores III or IV that have applied to emergency department and receives an indication for intubation by the intensive care unit physicians will be included to the study
Key exclusion criteria (1 listed)
- Patients using steroid prior to the intubation and/or patients with chronical inflammatory diseases will be excluded from the study.
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 |
|---|---|---|
| EtomidateAlso: etomidate lipuro, BRAUN | Drug | Etomidate, etomidate, steroid |
| MidazolamAlso: Dormicum,Roche | Drug | midazolam |
| methylprednisoloneAlso: Prednol-L, Mustafa Nevzat | Drug | etomidate, steroid |
Primary outcome
effect of use of steroid on adrenal cortex prior to single dose etomidate by comparing cortisol levels
Time frame: 24 hours
1 secondary outcome
compare effects of midazolam and etomidate on systemic blood pressure
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Background: PubMed 20828877Tekwani KL, Watts HF, Sweis RT, Rzechula KH, Kulstad EB. A comparison of the effects of etomidate and midazolam on hospital length of stay in patients with suspected sepsis: a prospective, randomized study. Ann Emerg Med. 2010 Nov;56(5):481-9. doi: 10.1016/j.annemergmed.2010.05.034. Epub 2010 Sep 15.
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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.
Fatis Altindas, Prof. study director
Chairman of the Department of Anesthesiology
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 Etomidate, Midazolam and methylprednisolone in people with Adrenocortical Deficiency and Hemodynamic Instability, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Aug 2013. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
effect of use of steroid on adrenal cortex prior to single dose etomidate by comparing cortisol levels (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01792037, which also lists 1 linked publication.
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 26 Aug 2013; AzTrials last refreshed its copy on 31 Oct 2026.