| CTRI Number |
CTRI/2025/12/099219 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Fluid therapy with Normal saline vs balance crystalloids in DKA] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Testing whether balanced iv fluids are better than normal saline for treating adults with diabetic ketoacidosis in the Emergency Department |
|
Scientific Title of Study
|
Balanced crystalloids versus normal saline efficacy in adults with diabetic ketoacidosis in the emergency department: prospective single blind randomized controlled superiority trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tarun Rana |
| Designation |
Junior resident |
| Affiliation |
Aiims Rishikesh |
| Address |
Emergency medicine department aiims rishikesh
AIIMS Rishikesh, Shivaji Nagar
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9719134505 |
| Fax |
|
| Email |
tarun.rana.pundir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat Bhushan Bhardwaj |
| Designation |
Assistant professor |
| Affiliation |
Aiims Rishikesh |
| Address |
Aiims rishikesh, emergency Medicine department.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7800001352 |
| Fax |
|
| Email |
bharat.em@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat Bhushan Bhardwaj |
| Designation |
Assistant professor |
| Affiliation |
Aiims Rishikesh |
| Address |
Aiims rishikesh, emergency medicine department.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7800001352 |
| Fax |
|
| Email |
bharat.em@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Aiims rishikesh, district Dehradun, Rishikesh 249203 India |
|
|
Primary Sponsor
|
| Name |
Tarun Rana |
| Address |
Aiims rishikesh, district Dehradun, Rishikesh-249203 India. |
| 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 Tarun Rana |
Aiims Rishikesh |
Aiims rishikesh emergency medicine department
Dehradun
UTTARANCHAL |
09719134505
tarun.rana.pundir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS RISHIKESH, INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E101||Type 1 diabetes mellitus with ketoacidosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balanced crystalloids ( Ringers lactate) |
Ringers lactate as only fluid in DKA management both in resuscitation and maintenance fluid. For the duration of 12 months |
| Comparator Agent |
Normal saline |
Normal saline as only fluid in DKA management both in resuscitation and maintenance phase. For the duration of 12 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient more than or equal to 18 years of age has clinical criteria satisfying for DKA.
blood glucose more than 200
Anion gap more than 10mmol per lit
Bicarbonate level less than 18
Presence of beta hydroxy butyrate or ketone in blood or urine |
|
| ExclusionCriteria |
| Details |
Patient received treatment from outside facility in form of iv fluids more than 1 litre.
Refered TO AIIMS for further care only.
Had euglycemic DKA |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time of resolution of DKA from starting of treatment. Its based on lab criteria, pH7.35 bicarbonate 18 meq/lit |
To find the time of DKA resolution, patient will be assessed every 2 hourly with venous blood gas. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare time to insulin pump discontinuation (hours)
To compare electrolyte abnormalities including hyperkalemia, hypokalemia & hyperchloridemia.
To compare intensive care unit admission & length of hospital stay.
To compare total length of hospital stay.
To compare in hospital all cause mortality
To compare in hospital acute kidney injury.
To compare major adverse kidney event within 30 days |
With in 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
27/12/2025 |
| 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
|
This trail is comparing the efficacy of fluids which is ringers lactate vs normal saline in resolution of DKA. As limited studies are present in the Emergency setting hence this trail is being done to collect more data that will be helpful in standardizing the fluid management of dka in emergency settings. |