| CTRI Number |
CTRI/2025/12/099048 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two blood pressure targets in children with septic shock |
|
Scientific Title of Study
|
A Non-Inferiority trial of comparison of two different blood pressure targets in treatment of pediatric septic shock: A multicentric, open, 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 Kapil Sachane |
| Designation |
Consultant Pediatric intensivist |
| Affiliation |
Rainbow Childrens hospital |
| Address |
PICU, 2nd floor, rainbow childrens hospital, road number 2, banjara hills, hyderabad 5000034
Hyderabad
TELANGANA
500034
India |
| Phone |
9112406452 |
| Fax |
|
| Email |
ksachane@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Sachane |
| Designation |
Consultant Pediatric intensivist |
| Affiliation |
Rainbow Childrens hospital |
| Address |
PICU, 2nd floor, rainbow childrens hospital, road number 2, banjara hills, hyderabad 5000034
Hyderabad
TELANGANA
500034
India |
| Phone |
9112406452 |
| Fax |
|
| Email |
ksachane@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kapil Sachane |
| Designation |
Consultant Pediatric intensivist |
| Affiliation |
Rainbow Childrens hospital |
| Address |
PICU, 2nd floor, rainbow childrens hospital, road number 2, banjara hills, hyderabad 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9112406452 |
| Fax |
|
| Email |
ksachane@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rainbow Childrens Hospital, Road number 2 , Banjara Hills, Hyderabad |
|
|
Primary Sponsor
|
| Name |
Rainbow childrens hospital |
| Address |
Road number 2, banjara hills, Hyderabad, 500034 |
| 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 Prathyusha P |
Rainbow Childrens Hospital |
PICU, Road number 2, Banjara Hills, Hyderabad 500034
Hyderabad
TELANGANA |
7382476970
pratyushareddy75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rainbow Childrens Hospital EC for biomedical and health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Children with septic shock will receive hemodynamic management targeting a mean arterial pressure between 5th to 50th centile for age and height, using standard therapies including fluid resuscitation, vasoactive agents and other supportive care as per unit protocol. |
| Comparator Agent |
Group B |
Children with septic shock will receive hemodynamic management targeting a mean arterial pressure between 50th to 90th centile for age, using standard therapies including fluid resuscitation, vasoactive agents and other supportive care as per unit protocol |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children between 1 month age to 18 years age with septic shock as defined by phoenix criteria |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Composite outcome of all-cause mortality or new/progressive multiple organ dysfunction syndrome |
28 days post-randomization. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ventilator free days |
28 days post-randomization |
| duration of PICU stay |
From PICU admission till PICU discharge or death assessed upto 28 days post-randomization |
| duration of hospital stay |
From hospital admission till hospital discharge or death, assessed upto 28 days post-randomization |
| Vasoactive agent free days |
28 days post-randomization |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2025 |
| 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="2"
Months="0"
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
|
A non-inferiority trial of comparison of two different
blood pressure targets in treatment of pediatric septic shock: open ,
randomized controlled trial
|