CTRI

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CTRI Number

CTRI/2024/08/072034 [Registered on: 07/08/2024] Trial Registered Prospectively

Last Modified On:

01/08/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparing between hydrocortisone and combination of dexamethasone with fludrocortisone for increasing blood pressure in adult patients with low blood pressure due to severe infections: a double blinded non inferiority randomized controlled trial

Scientific Title of Study

Effectiveness of hydrocortisone v/s combination of dexamethasone with fludrocortisone for shock reversal in adult patients with septic shock: a double blinded non inferiority randomized controlled 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	Jayanta Kumar Mitra
Designation	Professor
Affiliation	AIIMS Bhubaneswar
Address	Professor Department of Anesthesia AIIMS Bhubaneswar Khordha ORISSA 751019 India
Phone	9433798583
Fax
Email	anaes_jayanta@aiimsbhubaneswar.edu.in

Details of Contact Person
Scientific Query

Name	Jayanta Kumar Mitra
Designation	Professor
Affiliation	AIIMS Bhubaneswar
Address	Professor Department of Anesthesia AIIMS Bhubaneswar ORISSA 751019 India
Phone	9433798583
Fax
Email	anaes_jayanta@aiimsbhubaneswar.edu.in

Details of Contact Person
Public Query

Name	Boney John
Designation	Senior Resident
Affiliation	AIIMS Bhubaneswar
Address	Senior Resident Department of Anesthesia AIIMS Bhubaneswar Khordha ORISSA 751019 India
Phone	8610614335
Fax
Email	boneyjohn1996@gmail.com

Source of Monetary or Material Support

AIIMS Bhubaneswar

Primary Sponsor

Name	AIIMS Bhubaneswar
Address	AIIMS Bhubaneswar Bhubaneswar, Orissa 751019
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Boney John	All India Institue Of Medical Sciences Bhubaneswar	Department of Anesthesiology and critical care. Surgical ICU and Central ICU, 3rd floor, main hospital building. Khordha ORISSA	8610614335 boneyjohn1996@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, AIIMS Bhubaneswar	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: A419\|\|Sepsis, unspecified organism,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Dexamethasone with Fludrocortisone	Patients randomized to this group will get IV Dexamethasone 2mg QID and tablet Fludrocortisone 100ug OD for 7 days or till shock reversal or till death whichever is earlier.
Comparator Agent	Hydrocortisone	Patients randomized to this group will get Hydrocortisone 50mg IV QID for 7 days, till death, or till shock reversal whichever is earlier.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	patients presenting with septic shock to ICU requiring vasopressors to maintain mean arterial pressure more than or equal to 65mmHg for at least 4 hours.

ExclusionCriteria

Details

Patients already on steroids or likely to be on steroids for reasons other than septic shock.

Patient refusal

known allergies to study drugs.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Time for shock reversal, defined as time from initiation of steroid therapy to discontinuation of noradrenaline for 24 hours to a target MAP of 65mmHg.	at every 24 hours for 7 days.

Secondary Outcome

Outcome

TimePoints

To compare between the two groups
1) ICU mortality rate
2)proportion of patients requiring reinitiation of norepinephrine
3) mean daily insulin requirement during steroid therapy
4)mean number of episodes of hyperglycemia during steroid therapy.
5) proportion of new onset gastrointestinal bleed during steroid therapy
6) proportion of patients requiring transfusion due to gastrointestinal bleed.
7)proportion of patients showing new positive culture from a previously sterile site after initiating steroid therapy.

at every 24 hours for 7 days.

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
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)

29/08/2024

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="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

Septic shock patients coming to the ICU who require noradrenaline infusion to maintain mean arterial blood pressure more than or equal to 65mmHg for at least 4 hours will be divided into two parallel groups randomly. Hydrocortisone group will receive injection of Hydrocortisone 50mg IV QID for 7 days, till shock reversal or till death, whichever is earlier. The dexamethasone group will receive injection of dexamethasone 2mg IV QID and tablet fludrocortisone 100ug OD for 7 days, till shock reversal or till death, whichever is earlier. The primary outcome is to compare the time of shock reversal between the two groups