| CTRI Number |
CTRI/2025/11/097902 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding how blood lactate and albumin level help in identifying severity of septic shock in children |
|
Scientific Title of Study
|
Lactate Albumin ratio as a prognostic marker in children with 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 |
Dr Madhumitha Sadasivam |
| Designation |
Junior Resident |
| Affiliation |
MAHE |
| Address |
Department of Paediatrics
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7397588322 |
| Fax |
|
| Email |
madhumitha1.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep kumar |
| Designation |
Associate professor |
| Affiliation |
MAHE |
| Address |
Department of Paediatrics
Kasturba Medical College
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8197120018 |
| Fax |
|
| Email |
kumar.sandeep@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhumitha Sadasivam |
| Designation |
Junior Resident |
| Affiliation |
MAHE |
| Address |
Department of Paediatrics
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7397588322 |
| Fax |
|
| Email |
madhumitha1.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE MANIPAL , MADHAV NAGAR, MANIPAL , UDUPI , KARNATAKA , INDIA - 576104 |
|
|
Primary Sponsor
|
| Name |
Madhumitha Sadasivam |
| Address |
DEPARTMENT OF PAEDIATRICS, KASTURBA MEDICAL COLLEGE, MANIPAL, MADHAV NAGAR, MANIPAL, KARNATAKA, INDIA 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Madhumitha Sadasivam |
Kasturba Medical Hospital , Manipal Academy of Higher Education |
Department of Paediatrics , Manipal , Karnataka , India 576104
Udupi
KARNATAKA |
7397588322
madhumitha1.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R578||Other shock, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 month to 18 years of age admitted with diagnosis of septic shock in PICU |
|
| ExclusionCriteria |
| Details |
Children with Chronic liver disease, chronic kidney disease, nephrotic syndrome, protein losing enteropathy, severely malnourished, previously diagnosed with IEM having hyperlactatemia(mitochondrial disorder, disorder of pyruvate metabolism, disorder of gluconeogenesis, fatty acid oxidation), glycogen storage disease, Severe Acute Malnutrition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study LAR in children with septic shock , to determine association of LAR with severity of these children based on p-SOFA Score |
within 24 hours of admission or diagnosis and at discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine association of LAR with outcome such as mortality, length of PICU stay, length of mechanical ventilation, Vasoactive inotropic score . |
within 24 hours of admission or diagnosis, at discharge |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
02/12/2025 |
| 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="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
|
Sepsis is defined as life threatening organ dysfunction caused by dysregulated host immune response to infection.Sepsis in children is associated with high morbidity and mortality rates. Early identification, appropriate resuscitation and management are therefore critical to optimize the outcome for children with sepsis .Traditional markers like lactate and albumin have individually shown prognostic value in sepsis but affected by various physiological and pathological conditions . Lactate albumin ratio (LAR) has gained attention as simple, easily obtainable and cost-effective biomarker that may offer better prognostic accuracy than either parameter alone. Unlike complex scoring system like PRISM III (Paediatric Risk of Mortality), which require multiple clinical and laboratory variables, LAR can be rapidly derived using routinely available blood test results even in peripheral or low- resource settings. Despite its proven value in adult sepsis, data on LAR in Paediatric sepsis are limited especially in India. |