| CTRI Number |
CTRI/2024/10/075182 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
12/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Serum Cortisol Levels on Reversal of Shock in Adults with Septic Shock. |
|
Scientific Title of Study
|
Effect of Serum Cortisol Levels on Reversal of Shock in Adults with Septic Shock- A Prospective Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Senthilnathan M |
| Designation |
Associate Professor |
| Affiliation |
Autonomous institution |
| Address |
Department of Anaesthesiology and Critical care,
Room no.27
Jipmer campus road,
Gorimedu,Dhanvantari Nagar,Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7598566983 |
| Fax |
|
| Email |
mmc.senthil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ujjaini Pandi |
| Designation |
Student |
| Affiliation |
Autonomous institution |
| Address |
Department of Anaesthesiology and Critical care,
JIPMER campus road,Gorimedu,Dhanvantari Nagar,Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500421367 |
| Fax |
|
| Email |
ujjaini.pandi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthilnathan M |
| Designation |
Associate Professor |
| Affiliation |
Autonomous institution |
| Address |
Department of Anaesthesiology,
JIPMER Campus road,Gorimedu,Dhanvantari Nagar,Puducherry
PONDICHERRY
605006
India |
| Phone |
7598566983 |
| Fax |
|
| Email |
mmc.senthil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intra Mural Research Fund,JIPMER,puducherry,India-605006. |
|
|
Primary Sponsor
|
| Name |
Dr DMThappaIntra Mural Research FundJIPMER |
| Address |
Jipmer campus road,Gorimedu,
Dhanvantari Nagar,
Pondicherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Senthilnathan M |
JIPMER CCU |
Department of Anaesthesiology and Critical Care,Jipmer campus road,Gorimedu,
Dhanvantari Nagar,
Pondicherry-605006
Pondicherry
PONDICHERRY |
7598566983
mmc.senthil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Commitee for Observational Studies,JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults with septic shock requiring high vasopressor therapy to
maintain MAP of ≥ 65 mmHg for more than one hour, despite
adequate fluid therapy. |
|
| ExclusionCriteria |
| Details |
1.H/o Hypothalamic-pituitary-adrenal axis dysfunction
2.H/o Glucocorticoid/estrogen therapy
3. Patients with autoimmune disorders
4. Pregnancy
5. H/o drug intake that influence HPA axis response.
(Eg: ketoconazole). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the proportion of patients develops reversal of shock between responders
and non-responders. |
Time to reversal of shock,28 day mortality benefit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the 28 days mortality between critically ill septic shock adults between responders and non-responders.
To compare the length of ICU stay between critically ill septic shock adults between responders and non-responders.
To compare the need for RRT between critically ill septic shock adults be-tween responders and non-responders.
|
28 days of mechanical ventilator free days. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
23/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Administration of steroid therapy in patients with sepsis who have normal/high serum cortisol level may be deleterious as the steroid can worsen the ongoing infection. This study has been designed to study the effect of hydrocortisone on outcomes of septic shock adults with normal/high serum cortisol. |