| CTRI Number |
CTRI/2025/02/081031 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of two type of fluids for treatment of complicated diabetes in children and adults |
|
Scientific Title of Study
|
A multicentre cluster crossover randomized controlled trial of Normal Saline versus Ringer Lactate as fluid therapy for critically ill children and adults with Diabetic Ketoacidosis |
| Trial Acronym |
BLESSED |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayashree Muralidharan |
| Designation |
Professor and Chief Pediatric Emergency and PICU |
| Affiliation |
PGIMER Hospital Chandigarh |
| Address |
Department of Pediatric
APC Building
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
919815594343 |
| Fax |
|
| Email |
mjshree@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Muralidharan |
| Designation |
Professor and Chief Pediatric Emergency and PICU |
| Affiliation |
PGIMER Hospital Chandigarh |
| Address |
Department of Pediatric
APC Building
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
919815594343 |
| Fax |
|
| Email |
mjshree@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shani S Thankachen |
| Designation |
Project Manager |
| Affiliation |
George Institute for Global Health |
| Address |
The George Institute for Global Health
308 Third Floor Elegance Tower
New Delhi
New Delhi
DELHI
110025
India |
| Phone |
919990605537 |
| Fax |
|
| Email |
sthankachen@georgeinstitute.org.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of medical research |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Department of pediatric
APC Building
PGIMER Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 21 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urvi Shukla |
Aditya Birla Memorial Hospital |
Aditya Birla Hospital Marg, Thergaon, Pimpri-Chinchwad, Maharashtra 411033
Pune
MAHARASHTRA |
91 98811 23006
shuklaurvi@yahoo.com |
| Dr Upendra Hansda |
All India Institute of Medical Sciences |
Sijua Patrapada Bhubaneswar Orissa 751019
Khordha
ORISSA |
0674 2476789
uhansdah@gmail.com |
| Dr Suchitra Ranjit |
Apollo Children Hospital |
15 Shafee Mohammed Road
Thousand Lights West
Thousand Lights 600006
Chennai
TAMIL NADU |
914440401066
suchitraranjit@yahoo.co.in |
| Dr Ajay Padmanaban |
Apollo Main Hospital |
21 Greams Lane, Off Greams Road Chennai 600006
Chennai
TAMIL NADU |
914440401066
ajay@icuconsultants.com |
| Dr Pratheema Ramachandran |
Apollo Speciality Hospital OMR |
05/639, Old Mahabalipuram Road,
Chennai
Chennai
TAMIL NADU |
914440401066
pratheema@icuconsultants.com |
| Dr Ebenezer Rabindrarajan |
Apollo Specialty Hospital |
Plot No 64 Vanagaram Ambattur Rd
Ayanambakkam Ambattur Industrial Estate
Chennai
TAMIL NADU |
914440401066
ebenezer@icuconsultants.com |
| Dr Jignesh Shah |
Bharti Vidyapeeth Deemed University Medical College |
Bharati Vidyapeeth Educational Campus, Pune-Satara Road, Pune-411 043, Maharashtra, India
Pune
MAHARASHTRA |
91-20-24373226
jignesh.shah@bharatividyapeeth.edu |
| Dr Binila Chacko |
Christian Medical College |
Ida Scudder Rd Vellore 632004
Vellore
TAMIL NADU |
918000338855
binilachacko@gmail.com |
| Dr Sudha Chandelia |
Dr Ram Manohar Lohia Hospital, Delhi |
Near Gol Dak Khana, Gurdwara Bangla Sahib, Baba Kharak Singh Road, Connaught Place-110001
Central
DELHI |
91-11-23365525
sudhach83@rediffmail.com |
| Dr Kishore Mangal |
Fortis Escorts Hospital |
JLN Marg Malviya Nagar Opposite Clarks Amer Hotel 302017
Jaipur
RAJASTHAN |
91-124 4921021
drkishoremangal@gmail.com |
| Dr Anusha Cherian |
Jawaharlal Institute of Postgraduate Medical Education and Research |
JIPMER Campus Road, JIPMER Campus Puducherry 605006
Pondicherry
PONDICHERRY |
04132296000
anushacherian@gmail.com |
| Dr Narayanan Parameshwaran |
Jawaharlal Institute of Postgraduate Medical Education and Research |
JIPMER Campus Road, JIPMER Campus Puducherry 605006
Pondicherry
PONDICHERRY |
04132296000
narayanan.p@jipmer.edu.in |
| Dr Devachandran Jayakumar |
Kamakshi Memorial Hospital |
1 200 Feet Radial Rd
Dandeeswarar Nagar
Rose Avenue Pallikarnai
Chennai
TAMIL NADU |
994471200200
devajayakumar1@gmail.com |
| Dr Cynthia Amrutha |
Kasturba Medical College |
Tiger Circle Road
Madhav Nagar
Eshwar Nagar 576104
Udupi
KARNATAKA |
08202922761
cynthiaamrutha@gmail.com |
| Dr Rajesh Shetty |
Manipal Hospital Whitefield |
Manipal Hospitals Whitefield, ITPL Main Road, Opposite Prestige Shantiniketan, Whitefield, Bangalore-560066
Bangalore
KARNATAKA |
02068138888
rajeshshetty@manipalhospitals.com |
| DrJayashree Muralidharan |
PGIMER Chandigarh |
Department of Pediatric
APC Building
PGIMER sector 12
Chandigarh
Chandigarh
CHANDIGARH |
91-172-2747585
mjshree@hotmail.com |
| Dr Anil Sachdev |
Sir Ganga Ram Hospital |
A1 Sarhadi Gandhi Marg, Old Rajinder Nagar Rajinder Nagar New Delhi 110060
New Delhi
DELHI |
911142254000
anilcriticare@gmail.com |
| Dr Bhuvana Krishna |
St Johns Medical College |
Sarjapur Marathalli Road
Beside Bank of Baroda, John Nagar, Koramangala
Bangalore
KARNATAKA |
91 080 22065000
bhuvana.11@gmail.com |
| Dr Chetan Pande |
Symbiosis Hospital |
Dnyan marg
Mulshi Rd
Lavale
Maharashtra
Pune
MAHARASHTRA |
91 20-35087900
chetanpande002@gmail.com |
| Dr Sheila Nainan Myatra |
Tata Memorial Hospital |
Dr E Borges Road
Parel 400012
Mumbai
MAHARASHTRA |
912224177000
sheila150@hotmail.com |
| Dr Balaji Venkatachalam |
Vijaya Hospital |
No 434 Arcot Road Vadapalani 600026
Chennai
TAMIL NADU |
91 98843 99944
balaji@icuconsultants.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 22 |
| Name of Committee |
Approval Status |
| ABMH Ethics Committee |
Approved |
| Dr KMH-IEC |
Approved |
| Ethics Committee of Manipal Hospitals |
Submittted/Under Review |
| Ethics Committee, PGIMER, Dr. RML Hospital PGIMER, DR. RAM MANOHAR LOHIA HOSPITAL, NEW DELHI |
Approved |
| IEC Intervention Studies JIPMER |
Approved |
| IEC Intervention Studies JIPMER |
Approved |
| IEC of SIU |
Submittted/Under Review |
| IEC of SMBT IMS and RC |
Approved |
| Institutional Ethics Committee - Bio Medical Research Apollo Childrens Hospital Chennai |
Approved |
| Institutional Ethics Committee - Bio Medical Research Apollo Hospitals OMR |
Approved |
| Institutional Ethics Committee - Bio Medical Research Apollo Hospitals Vanagaram |
Approved |
| Institutional Ethics Committee - Bio Medical Research Apollo Main Hospital Chennai |
Approved |
| Institutional Ethics Committee Bharati Vidyapeeth Deemed University Pune |
Approved |
| Institutional Ethics Committee Fortis Escorts Hospital |
Approved |
| Institutional Ethics Committee Kasturba Medical College |
Approved |
| Institutional Ethics Committee ST JOHNS MEDICAL COLLEGE HOSPITAL |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, AlIMS Bhubaneswar |
Approved |
| Institutional Review Board Christian Medical College |
Approved |
| PGIMER Institutional Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
| TMH, Institutional Ethics Committee-I |
Approved |
| Vijaya Institute of Clinical and Medical Research Vijaya Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E111||Type 2 diabetes mellitus with ketoacidosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline |
The centres will be randomised under cluster randomisation for same intervention for 12 months. Study fluid will continue for each enrolled patient until discharge from ICU or for a maximum of 72 hrs, whichever is earlier |
| Intervention |
Ringer’s lactate |
The centres will be randomised under cluster randomisation for same intervention for 12 months. Study fluid will continue for each enrolled patient until discharge from ICU or for a maximum of 72 hrs, whichever is earlier |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All Patients admitted to ED/ICU with a diagnosis of DKA with all of the following criteria:
Blood glucose level more than 250 mg/dl
pH less than 7.25
serum bicarbonate more than 15 mmol/L
Anion gap more than 12 mmol/L
Ketonemia/ketonuria
|
|
| ExclusionCriteria |
| Details |
Patients with hyperosmotic hyperglycemic
non-ketotic syndrome
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hospital-free days |
28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome
ICU free days up to 28 days after randomisation
Acute kidney injury assessed by comparing serum creatinine concentrations between groups
Cerebral oedema
Time to resolution of ketosis
Cumulative insulin dosage in the first 48 hours
Hospital mortality
Tertiary Outcome
Health economic analysis |
28th day 24months |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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 3 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diabetic ketoacidosis (DKA), a
life-threatening complication of Diabetes, is associated with substantial
morbidity and mortality. India has more than 65 million cases of Diabetes and
an estimated 500000 cases of DKA annually with the highest prevalence in
younger patients. Objectives: In critically ill adult and paediatric patients with DKA, to
determine if fluid therapy with RL compared to NS increases the number of “days
alive and out of hospital†Methods: A multicentre randomized cluster cross-over
trial Novelty: This will be the largest trial in India comparing two commonly used IV
fluids in patients with DKA.
Expected Outcome: This
innovative trial will examine the safety and efficacy of a widely used intervention
on a clinically relevant endpoint- “days alive and out of hospital†, and thereby generating new knowledge. Reducing length of stay by one day would also lead to
savings of 7000 INR per patient per day to the healthcare system |