| CTRI Number |
CTRI/2024/07/070935 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare early restrictive and liberal fluid management for resistant hypotension in septic shock patients. |
|
Scientific Title of Study
|
Restrictive vs Liberal fluid management in sepsis induced hypotension |
| 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 Anamika Tiwari |
| Designation |
PG Resident |
| Affiliation |
Pt. JNM medical college ,Dr. BRAM hospital raipur |
| Address |
Dept of anesthesia Pt JNM medical college mekahara raipur (c.g)
Raipur
CHHATTISGARH
492001
India |
| Phone |
07999775711 |
| Fax |
|
| Email |
anamikatiwari321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya Lalwani |
| Designation |
Proffesor |
| Affiliation |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anesthesiology and Pain Medicine Pt JNM Meical College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9300224989 |
| Fax |
|
| Email |
jayalalwani2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anamika Tiwari |
| Designation |
PG Resident |
| Affiliation |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anesthesiology and Pain Medicine Pt JNM Meical College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
07999775711 |
| Fax |
|
| Email |
anamikatiwari321@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Pain Medicine, Pt JNM Medical College ,Opposite jail Road, Raipur, Chhattisgarh pin code 492001 |
|
|
Primary Sponsor
|
| Name |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anaesthesiology and Pain Medicine, Pt JNM Medical College ,Opposite jail Road, Raipur, Chhattisgarh pin code 492001 |
| Type of Sponsor |
Government medical college |
|
|
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 Anamika Tiwari |
Dr Bhimrao Ambedkar Memorial Hosptal Raipur Chhattisgarh |
First floor Critical care unit Department of critical care unit Raipur CG
Raipur
CHHATTISGARH |
07999775711
anamikatiwari321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUIONAL ETHICS COMMITTEE Pt JNM Medical College Raipur CG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R99-R99||Ill-defined and unknown cause of mortality, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
liberal fluid therapy |
Group B consist of patients with sepsis induced hypotension presented to ICU within 6 hours of hospital admission and MAP less than 65 mmHg give 2 liters of bolus fluid over 1 hour followed by 2 liters over next 4 hour to maintain MAP greater than 65 mmHg |
| Intervention |
Restrictive fluid therapy |
Group A consist of patients with sepsis induced hypotension presented to ICU within 6 hours of hospital admission and MAP less than 65 mmHg
first Vasopressor Noradrenaline 5 ampoule added and tirated to maintain MAP greater than65 mmHg
Reassess after 1 hour
if MAP less than 65mmHg then add second Vasopresor Vasopressin at the rate to maintain MAP greater than65mmHg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient from 18-65 years of age with sepsis induced hypotension confirmed through SIRS diagnostic criteria with MAP less than 65 mmHg |
|
| ExclusionCriteria |
| Details |
Previous reception of greater 3000ml of IV fluid
Elapse of greater than 6 hour on admission to hospital
End stage renal failure
Elevated jugular venous pressure
Gastrointestinal bleeding in absence of fever congestive heart failure |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Death from any cause before discharge home or by day 90 |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Days free from ventilator use |
90 days |
| day free from renal replacement therapy |
Day 90 |
| Days free from vasopressor use |
Day 90 |
| Day out of CCU |
By day 90 |
|
|
Target Sample Size
|
Total Sample Size="364"
Sample Size from India="364"
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 4 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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="1"
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
|
This is a prospective randomized study to compare restrictive vs liberal fluid management in patient undergoing sepsis induce hypotension.A total number of 364 patient were enrolled in the study presenting to the CCU and will be randomized onto two two groups through sealed envelope techniques .Group A with 182 patient receiving vasopressor as noradrenaline 5 ampoule till MAP is maintained greater than 65 mmHg Patient will be reassessed after one hour and if MAP is not maintain second vasopressor as Vasopressin at the rate 2.4 ml/hour will be started and will be assessed till one hour. In Group B with 182 patient will receive 2 liters of bolus fluid over 1 hour followed by 2 liters over next 4 hour to maintain MAP >65 mmHg Primary outcome will be measured as Death from any cause brfore discharge or by day 90 and secndary outcomes measured will be in terms of days free from ventilator use,days free from renal replacement therapy,days free from vasopressor use, days out of CCU.
|