| CTRI Number |
CTRI/2024/09/073418 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Standardized Mortality Ratio In Pediatric ICU |
|
Scientific Title of Study
|
STANDARDISED MORTALITY RATIO IN PICU |
| 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 Gauri Gupta |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical college Manipal |
| Address |
Pediatrics Department,
Kasturba hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9910874479 |
| Fax |
|
| Email |
gaurigtabest@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNEEL MUNDKUR C |
| Designation |
MD Pediatrics, Professor and HEAD OF UNIT |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of pediatrics, Kasturba Medical College, MAHE, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9845150802 |
| Fax |
|
| Email |
suneel.mundkur@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Leslie Edward S Lewis |
| Designation |
MD Paediatrics, Professor and HOD, Department of Paediatrics |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of pediatrics, Kasturba Medical College, MAHE, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9449208476 |
| Fax |
|
| Email |
leslie.lewis@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical college , Manipal, Kasturba Medical College, Madhav Nagar, Manipal, 576104 Udupi Karnataka ,India |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Gauri |
Kasturba Medical college and Hospital |
2nd floor, PICU , Women and children block, Department of Paediatrics, Kasturba Medical College, Madhav Nagar, Manipal, 576104
Udupi
Karnataka
Udupi
KARNATAKA |
9910874479
gaurigtabest@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, (2) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted in PICU over study period |
|
| ExclusionCriteria |
| Details |
Patients admitted in Pediatric intensive care unit from Postop care, immunosuppressed ,on dialysis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To
To analyze the Standardized Mortality Ratio in PICU.
|
8 WEEKS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To analyze the standardized Mortality Ratio in PICU.
2) To study the pattern of Standardized Mortality Ratio in Systemic diseases. |
At discharge |
|
|
Target Sample Size
|
Total Sample Size="850"
Sample Size from India="850"
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)
|
20/09/2024 |
| 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
|
Any patient who is one month to 18 years admitted in PICU will be included in the study. Patient’s data will be recorded including UNIQUE ID no. , main diagnosis in PICU (defined as the primary cause of admission in PICU),Outcome(death, or discharge or DAMA).The Data will be based on the patients medical history, physical examination and laboratory findings which were recorded by PI during first visit(immediately after admission to PICU).All lab investigations will be done as a part of the routine care and only the records will be reviewed. The components of the PRISM score will be recorded. The PRISM 3 score will be calculated for each patient and the probability of mortality will be seen. To calculate the standardised mortality ratio , the probability of death for each child that was determined based on PRISM 3 model and total amount of probability of death in the study population will be obtained. Then SMR will be calculated by dividing the number of deaths occurred to the expected. Standardized Mortality Ratio = Observed death/Expected death * 100.An SMR<1 indicates that the actual mortality is lower than the expected one; thus the quality of therapeutic management is considered to be appropriate. An SMR >1 means that actual mortality is higher than the expected one, which is evidence of poor quality of service. Pattern of SMR in various systemic diseases will be seen. |