| CTRI Number |
CTRI/2024/11/077222 [Registered on: 22/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of use of an anaesthetic agent (Etomidate) on Cortisol levels, a stress hormone, when used for intubation (A procedure to protect the airway with a tube) |
|
Scientific Title of Study
|
Effect of use of single dose of Etomidate on serum cortisol levels in patients requiring rapid sequence intubation in ED (ETOCORT trial):An Observational Study |
| Trial Acronym |
ETOCORT trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarat Chandra Uppaluri |
| Designation |
Consultant in Emergency medicine |
| Affiliation |
AIG Hospitals |
| Address |
Department of Emergency Medicine, AIG Hospitals, Gachibowli, Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
9705758226 |
| Fax |
|
| Email |
sarat.uppaluri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarat Chandra Uppaluri |
| Designation |
Consultant in Emergency medicine |
| Affiliation |
AIG Hospitals |
| Address |
Department of Emergency Medicine, AIG Hospitals, Gachibowli, Hyderabad
TELANGANA
500027
India |
| Phone |
9705758226 |
| Fax |
|
| Email |
sarat.uppaluri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarat Chandra Uppaluri |
| Designation |
Consultant in Emergency medicine |
| Affiliation |
AIG Hospitals |
| Address |
Department of Emergency Medicine, AIG Hospitals, Gachibowli, Hyderabad
TELANGANA
500027
India |
| Phone |
9705758226 |
| Fax |
|
| Email |
sarat.uppaluri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute grant provided by AIG Hospitals,
AIG Hospitals, Mindspace road, Gachibowli, Hyderabad, Telangana, India, 500032 |
|
|
Primary Sponsor
|
| Name |
AIG Hospitals |
| Address |
AIG Hospitals, Mindspace road, Gachibowli, Hyderabad, Telangana, India, 500027 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sarat Chandra Uppaluri |
AIG Hospitals |
Ground floor, Department of emergency medicine, Mindspace road, Gachibowli, Hyderabad, 500032
Hyderabad
TELANGANA |
9705758226
sarat.uppaluri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Asian Institute of Gastroenterology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etomidate for Rapid sequence intubation |
Etomidate at dose of 0.3 mg/kg as applicable given intravenously. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Patients receiving a single dose of etomidate as the induction agent for intubation
-Patients who can provide informed consent or for whom consent can be obtained from a legally authorized representative |
|
| ExclusionCriteria |
| Details |
-Patients with known adrenal insufficiency or receiving chronic corticosteroid therapy
- Patients with a recent history of etomidate exposure (Within 24 hours)
- Patients with contraindications to Etomidate
- Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure and assess the decrease in serum cortisol levels compared to pre-intubation baseline at 30 minutes and 24 hours post intubation |
0 minutes, 30 minutes and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| all cause mortality |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sarat.uppaluri@gmail.com].
- For how long will this data be available start date provided 01-05-2025 and end date provided 08-05-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Rapid sequence intubation is a critical and time sensitive procedure performed in emergency departments. It involves administration of an induction agent and a paralytic agent to facilitate rapid tracheal intubation. Etomidate is frequently chosen due to its rapid onset and short duration and minimal cardiovascular effects. But it also inhibits cortisol synthesis thereby reducing the cortisol’s levels. Cortisol plays a pivotal role in body’s stress response thereby maintaining blood pressure, metabolism and immune function. The above effect of etomidate led to a growing body of literature examining the clinical implications of its use, particularly in those patients who are susceptible to adrenal insufficiency, for example, sepsis, burns and polytrauma. This study, therefore aims to investigate the effect of a single dose of Etomidate on cortisol levels in patients undergoing rapid sequence intubation in the ED and thereby evaluating the extent of cortisol suppression and its actual clinical implications |