| CTRI Number |
CTRI/2024/12/077910 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Is the blood pressure corrected by the tablet fludrocortisone in patients with low blood pressure in ICU. |
|
Scientific Title of Study
|
Effectiveness of early administration of fludrocortisone in septic shock: A prospective, Double Blind, Randomized control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Viswanath S |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesia, Pain, and Critical Care Medicine.
South
DELHI
110029
India |
| Phone |
09524060300 |
| Fax |
|
| Email |
sviswanath20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesia, Pain, and Critical Care Medicine, AIIMS, New Delhi.
South
DELHI
110029
India |
| Phone |
8595075008 |
| Fax |
|
| Email |
drrakesh.kumar.akb@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Viswanath S |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesia, Pain, and Critical Care Medicine.
South
DELHI
110029
India |
| Phone |
09524060300 |
| Fax |
|
| Email |
sviswanath20@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, New Delhi, India. PIN code: 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
AIIMS, New Delhi, India. Pin code: 110029 |
| Type of Sponsor |
Research institution |
|
|
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 Viswanath S |
All Institute of Medical Sciences, New Delhi |
Icu under Department of Anesthesia, Pain and Critical care medicine, AIIMS, New Delhi, India. Pin code: 110029
South
DELHI |
9524060300
sviswanath20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early administration of oral fludrocortisone in septic shock patients. |
Adult patients with septic shock within 24 hours of norepinephrine initiation, oral fludrocortisone 50 micrograms will be administrated for 7 days or till shock resolution , whichever is early in the study group. |
| Comparator Agent |
Placebo(glucose powder) |
5 grams of glucose powder (placebo) will be administered in adult patients with septic shock within 24 hours of norepinephrine initiation for 7 days in the control group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with septic shock within 24 hours of initiation of norepinephrine. |
|
| ExclusionCriteria |
| Details |
Age less than 18 years and more than 75 years. Pregnant and lactating patients, Patients with known history of chronic kidney disease, chronic liver disease, congestive heart failure, patients with hypernatremia and hypokalemia, high vasopressor requirement are excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of early administration of fludrocortisone and vasopressor-free days in early septic shock within the first 14 days of recruitment. |
At baseline and within first 14 days of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Duration of shock (Total days on vasopressor)
• Total daily vasopressors dose from days 1to14.
• Change in SOFA in the first seven days of enrolment.
• Ventilator-free days at day 30 after enrolment.
• ICU-free days at day 30 after enrolment.
• Mortality in the first 30 days of recruitment.
• Incidence of hypernatremia
• Incidence of hypokalaemia
• Incidence of hyperglycaemia
• Incidence of RRT
• Change in CRP, IL 6 during the first seven days after recruitment.
• Hospital-acquired infections.
|
At end of 30 days from recruitment. |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
01/01/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
To evaluate the effect of early administration of fludrocortisone and its effect in septic shock resolution. Recruitment of the cases will be started from 01/01/2025 till sample size is completed. |