| CTRI Number |
CTRI/2024/01/061693 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
correlation between inotrope and oxygen saturation of brain |
|
Scientific Title of Study
|
correlation between the dose of vasopressor and cerebral perfusion in patients of septic shock. |
| 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 Pravin Kumar Das |
| Designation |
Head of the Department |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Room 14, Department of Anaesthesiology and CCM, Administrative block,Dr Ram Manohar Lohia Institute of Medical Sciences, Lohia Path, Vibhuti Khand, Gomti Nagar, Lucknow
Room 14, Department of Anaesthesiology and CCM, Administrative block, Dr Ram Manohar Lohia Institute of Medical Sciences, Lohia Path, Vibhuti Khand, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7275068939 |
| Fax |
|
| Email |
drdas_73@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin Kumar Das |
| Designation |
Head of the Department |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Room 14, Department of Anaesthesiology and CCM, Administrative block,Dr Ram Manohar Lohia Institute of Medical Sciences, Lohia Path, Vibhuti Khand, Gomti Nagar, Lucknow
Room 14, Department of Anaesthesiology and CCM, Administrative block,Dr Ram Manohar Lohia Institute of Medical Sciences, Lohia Path, Vibhuti Khand, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH
226030
India |
| Phone |
7275068939 |
| Fax |
|
| Email |
drdas_73@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhanu Chaudhary |
| Designation |
Junior Resident |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Room 825, Dr SC Rai Hostel, Dr Ram Manohar Lohia Institute of Medical Sciences, Lohia Path, Vibhuti Khand, Gomti Nagar, Lucknow
Room 825, Dr SC Rai Hostel, Dr Ram Manohar Lohia Institute of Medical Sciences, Lohia Path, Vibhuti Khand, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7302276990 |
| Fax |
|
| Email |
bhanuchaudhary@protonmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ram Manohar Lohia Institute of Medical Sciences, Lohia Path, Vibhuti Khand, Gomti Nagar, Lucknow |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Bhanu Chaudhary |
Dr Ram Manohar Lohia Institute of medical sciences |
ICU First floor
Department of Anaesthesiology and CCM
Dr. Ram Manohar Lohia Institute Of Medical Sciences
Lucknow
UTTAR PRADESH |
7302276990
bhanuchaudhary@protonmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Dr Ram Manohar Lohia Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Near Infrared Spectroscopy |
Two sensors will be placed on the frontal region of the forehead of the patient by means of adhesive electrodes. The electrodes will stay intact for a duration of 4 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with sepsis on vasopressor support. |
|
| ExclusionCriteria |
| Details |
Refusal to consent.
Patient with age less than 18 years.
Patient with age more than 65 years.
Multi organ dysfunction.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We are expecting an inverse correlation between the dose of vasopressor and oxygen saturation of brain. |
Baseline and then 4 hourly. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the most effective dose of vasopressor that does not alter the end organ perfusion. |
Baseline & after 4 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| 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="6"
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
|
This is an open label, non-randomized single group observational single center study. We are trying to correlate the dose of vasopressor and its effect on oxygen saturation of brain. There is no intervention required and no financial burden will be put on patient. There will be total of 60 patients and we are expecting that on increasing dose of vasopressor there will be a decrease in oxygen saturation of brain. This will help us to find the appropriate dose of vasopressor that does not compromise the oxygen saturation and vital organ perfusion. |