| CTRI Number |
CTRI/2024/08/071911 [Registered on: 05/08/2024] 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
|
A study to compare the efficacy of Vasopressin (newer medicine)and Norepinephrine (commonly used medicine) in babies with septic shock |
|
Scientific Title of Study
|
A Double blinded Randomized study to compare the efficacy of Vasopressin versus Norepinephrine determined by improvement in markers of tissue perfusion within first sixty minutes in neonates with fluid refractory 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 |
Anurag Sanjeev Pikle |
| Designation |
DM, Senior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, 2nd floor, Bharati Hospital, Dhanakavadi, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9731631701 |
| Fax |
|
| Email |
pikle.anurag94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep B. Suryawanshi |
| Designation |
Professor and Head |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
Department of Neonatology, Bharati Hospital, Dhanakavadi, Pune.
NICU, Department of Neonatology, Bharati Hospital, Dhanakavadi, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9923540500 |
| Fax |
|
| Email |
drpradeepsuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anurag Sanjeev Pikle |
| Designation |
DM, Senior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, 2nd floor, Bharati Hospital, Dhanakavadi, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9731631701 |
| Fax |
|
| Email |
pikle.anurag94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University Medical College,
Dhanakavadi, Pune 411043, Maharashtra state, India. |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed University Medical College Pune |
| Address |
NICU, Bharati Hospital, Dhanakavadi, Pune 411043, Maharashtra state, India |
| Type of Sponsor |
Private 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 Anurag Sanjeev Pikle |
NICU |
Department of Neonatology, Bharati Hospital, Dhanakavadi, Pune 411043
Pune
MAHARASHTRA |
9731631701
pikle.anurag94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Norepinephrine |
One arm of the study will be neonates with fluid refractory septic shock who will be treated with Norepinephrine. Standard dose of drug will be used, starting from 0.07mcg/kg/min and will be stepped up by 0.06mcg/kg/min till improvement in shock is seen or till 1 hour of starting. If no improvement is noted, other inotropes will be considered depending on the status of the patient |
| Intervention |
Vasopressin |
One arm of the study will be neonates with fluid refractory septic shock who will be treated with Vasopressin. Standard dose of drug will be used, starting from 0.2mU/kg/min and will be stepped up by 0.2mU/kg/min till improvement in shock is seen or till 1 hour of starting. If no improvement is noted, other inotropes will be considered depending on the status of the patient |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All neonates admitted to NICU with signs of septic shock. |
|
| ExclusionCriteria |
| Details |
1. Septic neonates with poor ventricular contractility on functional ECHO.
2. Pre-existing heart disease (clinically or echocardiographic diagnosed) or arrhythmias.
3. Out born neonates with ongoing sepsis, and on inotropic/vasopressor support prior to enrolment
4. Congenital life-threatening anomalies
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in markers of tissue perfusion |
Sixty minutes of starting drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate duration of using vasopressor |
7 days |
| To evaluate the need for additional vasopressor |
7 days |
| To evaluate safety profile of Vasopressin |
7 days |
| To compare complications of both the drugs |
at discharge of the baby |
| Mortality |
at death of the baby, if the baby expires or at the discharge of the baby |
| Length of stay |
at discharge of the baby |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
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)
|
13/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
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 study will help compare the efficacy of Vasopressin and Norepinephrine in fluid refractory septic shock in neonates in terms of improvement in markers of tissue perfusion. |