| CTRI Number |
CTRI/2025/10/095645 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Outcome of Metabolic resucuitation:HAT Therapy in patients of SAM with Sepsis/Septic Shock. |
|
Scientific Title of Study
|
Outcome of Hydrocortisone,Ascorboc Acid and Thiamine therapy in patients of Severe Acute Malnutrition with Sepsis or 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 |
AMULYA PANDEY |
| Designation |
PG RMO |
| Affiliation |
shyam shah medical college |
| Address |
Department of Paediatrics
Shyam Shah Medical College
rewa
Mp
rewa mp
Rewa
MADHYA PRADESH
486001
India |
| Phone |
8159034300 |
| Fax |
|
| Email |
dramulyapandey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karan Joshi |
| Designation |
PROFESSOR |
| Affiliation |
SHYAM SHAH MEDICAL COLLEGE |
| Address |
Department of Paediatrics,Shyam Shah Medical college RewA 486001
Department of Paediatrics ,Shyam Shah Medical College Rewa.
Rewa
MADHYA PRADESH
486001
India |
| Phone |
94251849756 |
| Fax |
|
| Email |
drkaranjoshi65@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karan Joshi |
| Designation |
PROFESSOR |
| Affiliation |
SHYAM SHAH MEDICAL COLLEGE |
| Address |
Department of Paediatrics,Shyam Shah Medical College Rewa,MP.
Rewa
MADHYA PRADESH
486001
India |
| Phone |
94251849756 |
| Fax |
|
| Email |
drkaranjoshi65@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amulya Pandey |
| Address |
Department of Paediatrics ,Shyam Shah Medical College Rewa |
| 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 Amulya pandey |
Gandhi Memorial Hospital Rewa |
Department of Pediatrics SSMC ,Rewa
486001
Rewa
MADHYA PRADESH |
8159034300
dramulyapandey@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: E46||Unspecified protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Hydrocortisone,Ascorbic Acid and Thiamine Therapy . |
IV Hydrocortisone 1mg/kg/dose in slow bolus 6 hourly.
IV Ascorbic Acid 30 mg/kg/dose every 6 hourly over 30-60 minutes.
IV Thiamine 4mg/kg/dose every 12 hourly infused over 30-60 mins. |
| Comparator Agent |
Standard Treatment for Sepsis. |
Standard treatment for Sepsis including higher antibiotics,ionotropes ,oxygen supplementation ,fluids and electrolytes. |
|
|
Inclusion Criteria
|
| Age From |
29.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
All patients Fulfilling the Sam Criteria of weight by height less than 3 standard deviation ,Mid upper arm circumference less than 115cm or Bilateral Pedal Oedema. |
|
| ExclusionCriteria |
| Details |
Renal Failure ,Hepatic Failure ,other causes of Shock (hypovolemic,haemorrhagic,cardioigenic and neurogenic),Metabolic disorders,Chemotherapy/Steroid Therapy patients. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome of Hydrocortisone Ascorbic Acid and thiamine therapy in patients of sam with sepsis /septic shock.
Pheonix sepsis score and fss score assessed. |
At 0 ,3 and 7 days after admission.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effectiveness of HAT therapy in recovery from septic shock assessed in terms of
Number and duration of inotrope requirement
Duration of Invasive & Non Invasive Mechanical Ventilation
Duration required for reversal of septic shock
Duration of stay in PICU
Duration of Hospital stay
Survival and mortality percentages of both treatment groups
|
28 days
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2025 |
| 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
|
this hospital based randomised controlled trial aims to evaluate the effectiveness of intervention in children admitted to picu and wards.the primary outcome will be improvement in ,main clinical parameter e.g., oxygenation,ionotrope requirement, vitals and phoenix sepsis score.Secondary outcomes include assessment of adverse effects ,duration of hospital stay, need for mechanical ventilation and mortality.the study will be conducted over 1.5years AT GANDHI MEMORIAL HOSPITAL ,rewa.Eligible participants will be randomised into intervention and control groups.data will be analysed to determine both efficacy and safety of intervention. |