| CTRI Number |
CTRI/2025/03/082944 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [FLUIDS AND PHARMACOLOGICAL INTERVENTIONS] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Control Study Of Mean Arterial Pressure Monitoring, by comparing high vs low bp In Paediatric Septic Shock On Vasoactive Therapy |
|
Scientific Title of Study
|
A Randomized Control Study Of Mean Arterial Pressure Monitoring In Paediatric Septic Shock On Vasoactive Therapy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
battula gayatri |
| Designation |
junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, |
| Address |
Datta Meghe Institute of Higher Education and Research, Department of Pediatrics, JNMC, Sawangi, Wardha Wardha MAHARASHTRA 442107 India
Wardha
MAHARASHTRA
442107
India |
| Phone |
9392235555 |
| Fax |
|
| Email |
gayatrireddy369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Revat J Meshram |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, |
| Address |
Datta Meghe Institute Of Higher Education and Research, Department Of Pediatrics, JNMC, Sawangi, Wardha Wardha MAHARASHTRA India
Wardha
MAHARASHTRA
442107
India |
| Phone |
9823763989 |
| Fax |
|
| Email |
rjmeshram@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Battula Gayatri |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, |
| Address |
Datta Meghe Institute of Higher Education and Research, Department of Pediatrics, JNMC, Sawangi, Wardha Wardha MAHARASHTRA India
Wardha
MAHARASHTRA
442107
India |
| Phone |
9392235555 |
| Fax |
|
| Email |
gayatrireddy369@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Department of Pediatrics, JNMC, Sawangi, Wardha,442001,India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Maharashtra
442001
India |
| 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 Gayatri Battula |
Datta Meghe Institute of Higher Education and Research, |
Department of Pediatrics, PICU, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha Wardha MAHARASHTRA
Wardha
MAHARASHTRA |
9392235555
gayatrireddy369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| e Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? DMIHER Institutional Commttee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
high target blood pressure group |
fluid and vasoactive drugs require to maintain target blood pressure above 50th centile according to paediatric age group for 3days |
| Intervention |
low target blood pressure group |
fluid and vasoactive drugs require maintain blood pressure between 5 th to 50 th centile for 3 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Critically ill children between the age of 1 month to 18 years admitted to PICU.
2.Patients with septic shock on vasoactive drugs
|
|
| ExclusionCriteria |
| Details |
1.Refusal of consent.
2.Patient with hypertension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mean arterial pressure with better survival and less PICU stay |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of mechanical ventilation
Duration of hospital stay
Duration of vasoactive therapy
Duration of picu stay
Comorbidies with involvement of renal , hepatic , neuronal damage
mortality
|
3 days |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
25/03/2025 |
| 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="2"
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
|
After obtaining the informed consent from the parents and guardians , children will included in the study , allCritically ill children between the age of 1 month to 18 years with septic shock on vasoactive drugs admitted in PICU , avbrh , Sawanagi,Meghe , wardha , will be included the design of this study is randomized was performed with the use of computer generated assignment sequence, the blood pressure is assessed and measured according to age , height , sex of the child , the patients are divided into two groups , high targeted bp and low targeted group , in the low targeted group the bp is maintained between the. 40 th -50tg centile and in high targeted blood pressure is maintained at 50 th - 60 th centile range with titration of fluids and vasoactive drugs and the analysis can be done based on variables for quantitative variables will be expressed as standard deviation , and use t tests to compare each group and for qualitative variable chisquare test is used , and the main objective to determine the outcome of shock with low and high targeted MAP and to study end organ damages in cases of septic shock |