| CTRI Number |
CTRI/2025/02/081292 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Comparative analysis ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Time based effect of noradrenaline in patients with sepsis with hypotension presenting to emergency department |
|
Scientific Title of Study
|
Therapeutic response of early institution of noradrenaline in patients with sepsis with hypotension presenting to emergency department |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna Ramjan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Emergency Medicine
CGB, IPD building
AIIMS Patna
Phulwari Sharif
Patna, Bihar
Pincode: 801507
Patna
BIHAR
801507
India |
| Phone |
9037335983 |
| Fax |
|
| Email |
draparnaramjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aaruni Rahul |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Dr Aaruni Rahul
Department of Emergency Medicine
CGB, IPD building
AIIMS Patna
Phulwari Sharif
Patna, Bihar
Pincode: 801507
Phone number: 8587071099
Email id : dr.aaruni13113@aiimspatna.org
Patna
BIHAR
801507
India |
| Phone |
8587071099 |
| Fax |
|
| Email |
dr.aaruni13113@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Aparna Ramjan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Emergency Medicine
CGB, IPD building
AIIMS Patna
Phulwari Sharif
Patna, Bihar
Pincode: 801507
Patna
BIHAR
801507
India |
| Phone |
9037335983 |
| Fax |
|
| Email |
draparnaramjan@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS PATNA
Phulwari Sharif
Patna
Bihar
India
Pincode:801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
AIIMS PATNA
Phulwari Sharif
Patna, Bihar
Pin code : 801507 |
| 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 APARNA RAMJAN |
AIIMS PATNA |
Emergency Room
Department Of Emergency Medicine
CGB, IPD Building
AIIMS PATNA
Phulwari Sharif
Patna
Bihar
Pin Code: 801507
Patna
BIHAR |
9037335983
draparnaramjan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Noradrenaline from 0 to 3 hours |
Patients of sepsis with hypotension will be started on fluid therapy at 30 millilitre per kilogram as fluid bolus, fluid response will be assessed at 30 minutes and noradrenaline will be initiated intravenously at a rate of 0.25 to 0.5 microgram per kilogram per minute within 3 hours of presentation until mean arterial pressure of more than or equal to 65 millimeters of mercury is achieved
|
| Comparator Agent |
Inj noradrenaline within 3 to 6 hours |
Patients of sepsis with hypotension will be started on fluid therapy at 30 millilitre per kilogram which will be given as fluid bolus over 3 hour and if they persist to be in shock, noradrenaline will be started intravenously at a dose of 0.25 to 0.5 microgram per kilogram per minute from 3 to 6 hours of presentation until mean arterial pressure of more than or equal to 65 millimeters of mercury is achieved
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients above 18 years of age
2.All patients with hypotension determined by mean arterial pressure lower than 65 mm Hg and infection as the suspected cause if they met diagnostic criteria for sepsis according to surviving sepsis guidelines more than or equal to 2 of SIRS criteria
|
|
| ExclusionCriteria |
| Details |
1. All those patients who already received vasopressors from outside
2. Patients in whom other causes of shock are found eventually in the course of study
3. Patients requiring vasopressors other than noradrenaline
4. Pregnant females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study shock control rate in terms of achievement of sustained MAP greater than 65 mm Hg, urine output of greater than 0.5 ml/kg/h for 2 consecutive hours, or decrease in serum lactate by more than 10% from the initial lactate level in patients of sepsis with hypotension by 6 hours of presentation to emergency department. |
6 hours of presentation to emergency department. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate duration of hospital stay, duration of ICU stay, and in-hospital mortality in patients of sepsis with hypotension receiving noradrenaline within 3 hrs and 3 to 6 hrs of emergency medicine department presentation.
|
28 days |
| To estimate number of patients requiring mechanical ventilator support and number of patients requiring renal replacement therapy among patients of sepsis with hypotension receiving noradrenaline within 3 hrs and 3 to 6 hrs of emergency medicine department presentation. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Recent retrospective evidence suggests the efficacy of early noradrenaline administration during resuscitation; however, prospective data to support this assertion are scarce.The information from this study will make it easier to comprehend how prompt vasopressor support is not only essential for survival but may also be linked to reversing organ failure and shortening hospital stays. Many studies have compared different vasopressor agents for the resuscitation of septic shock but very few have investigated the role that the timing of vasopressor initiation in relation to hypotension onset plays in outcome.Data in relation to the populations of India and Asia are still scarce.In order to make this research relevant to the Indian populace, we intend to conduct it at our institution.The aim of this study is to assess the difference in outcomes in patients with sepsis (SIRS > 2) receiving noradrenaline within 3 hrs and 3 to 6 hrs of emergency medicine department presentation. We hope to learn how the timing of noradrenaline delivery in patients of sepsis with hypotension affects mortality, recovery, hospital stay, need for ventilation and haemodialysis, through this study.
|