| CTRI Number |
CTRI/2025/03/083025 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative Efficacy of Levosimendan and Milrinone in Catecholamine-Resistant Septic Shock with Myocardial Dysfunction in Children: A Single-Center, Open-Label RCT |
|
Scientific Title of Study
|
Comparison Of Efficacy Of Levosimendan Versus Milrinone In Catecholamine Resistant Septic Shock With Myocardial Dysfunction In Children : A Single-Center, Open-Label 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 |
Dr. Pawan Kumar |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Patna |
| Address |
pediatric office, department of paediatrics
AIIMS Patna
Patna
BIHAR
801503
India |
| Phone |
7005783748 |
| Fax |
|
| Email |
pawankr120890@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun prasad |
| Designation |
professor |
| Affiliation |
AIIMS, Patna |
| Address |
pediatric office, department of pediatrics, AIIMS, Patna
Patna
BIHAR
801503
India |
| Phone |
7005783748 |
| Fax |
|
| Email |
drarunp@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Pawan Kumar |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Patna |
| Address |
pediatric office, department of pediatrics, AIIMS, Patna
Patna
BIHAR
801503
India |
| Phone |
7005783748 |
| Fax |
|
| Email |
pawankr120890@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Patna, BIHAR, INDIA, pin-801507 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA |
| Address |
Department of pediatrics
AIIMS PATNA
dist-Patna
state - Bihar
India
Pin-801507 |
| 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 PAWAN KUMAR |
AIIMS, PATNA |
Department of paediatrics, AIIMS, PATNA
Patna
BIHAR |
7005783748
pawankr120890@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I958||Other hypotension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Milrinone |
Drug Milrinone @ dose 0.25 mcg/kg/min. After 15 min if no response then Drug Milrinone @ dose 0.5 mcg/kg/min. After 15 min if no response then Drug Milrinone @ dose 0.75 mcg/kg/min. |
| Intervention |
levosimendan |
Drug levosimendan @ 0.05mcg/kg/min. After 15 min if no response then increase Drug levosimendan @ 0.1mcg/kg/min After 15 min if no response then increase Drug levosimendan @ 0.15mcg/kg/min After 15 min if no response then increase Drug levosimendan @ 0.2mcg/kg/min |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All the patients admitting in Paediatric emergency and pediatric intensive care unit, AIIMS Patna, with diagnosis of catecholamine resistant septic shock with and cardiac Index less than 3.3L/MIN/M2
|
|
| ExclusionCriteria |
| Details |
Patient requiring CPR at presentation
Cardiomyopathy, cardiothoracic surgery within the previous 14 days.
congenital heart disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement of cardiac function based on fractional shortening and cardiac index (by 2D ECHO), Heart rate & Blood pressure (age & sex adjusted), lactate levels.
|
1 DAY
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for improvement in cardiac function, survival outcome.
|
AT DISCHARGE |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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="0"
Months="9"
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
|
- Patients presenting to Paediatric department of AIIMS Patna (meeting inclusion criteria) will be randomly allocated in 1:1 ratio to two independent treatment groups using opaque sealed envelope method:
Group A: Receives levosimendan as an ionodilator drug therapy
Group B: Receives milrinone as an ionodilator drug therapy After sample selection as per inclusion criteria after randomization children were started on either milrinone or levosimendan. As levosimendan is in powder form, it will be diluted in 5ml normal saline (standard dilution) to make clear fluid. Milrinone is available as clear fluid and both of these drug is stable for more than 24 hours at room temperature when given as an infusion However if shock persists after the study protocol treating team may further decide the use of any inotrope as open label as per type of shock & clinical profile of the patient using their description
|