| CTRI Number |
CTRI/2024/10/074986 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Fluid for resuscitation ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Normal saline vs balanced salt solution for resuscitation fluid in patients with DKA |
|
Scientific Title of Study
|
A Randomized Control trial to Compare Balanced Salt Solution with Normal Saline for fluid resuscitation in pateints with Diabetic Ketoacidosis reporting to Emergency Department. |
| 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 Kriti Gupta |
| Designation |
PG JR |
| Affiliation |
AIIMS raipur |
| Address |
Department of trauma and emergency,
Ground floor
AIIMS Raipur, tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9329698684 |
| Fax |
|
| Email |
kriti.gupta0250@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debendra Tripathy |
| Designation |
Professor and Head of department of trauma and emergency |
| Affiliation |
AIIMS raipur |
| Address |
AIIMS Raipur, tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9329698684 |
| Fax |
|
| Email |
drdebendra@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kriti Gupta |
| Designation |
PG JR |
| Affiliation |
AIIMS raipur |
| Address |
Department of trauma and emergency
Ground floor,
AIIMS Raipur, tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9329698684 |
| Fax |
|
| Email |
kriti.gupta0250@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of trauma and emergency, AIIMS Raipur, tatibandh, Raipur, Chhattisgarh state, 492099
India |
|
|
Primary Sponsor
|
| Name |
Dr Kriti Gupta |
| Address |
AIIMS Raipur, emergency medicine, ground floor, tatibandh, Raipur, CG, 492099
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 kriti |
AIIMS Raipur |
department of trauma and emergency
Ground floor
Raipur
CHHATTISGARH |
9329698684
kriti.gupta0250@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECaiimsRaipur |
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 |
Balanced salt solution |
Balanced salt solution vs normal saline to be used as fluids for resuscitation
Time taken to DKA resolution shall be compared in both groups to study the difference if any
DKA resolution will be determined using criteria under ADA guidelines. This study shall be completed over a period of 18 months |
| Intervention |
Normal saline vs balanced salt solution |
Normal saline given as intervention in one arm and BSS as comparator in other arm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Fitting the ADA criteria for DKA |
|
| ExclusionCriteria |
| Details |
Pt with hypervolemia or conditions where giving liberal fluid is contraindicated. Pregnant women |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of DKA resolution
Resolution will be considered in correspondence to ADA guidelines for DKA.
|
Assessment and assignment to DKA as per ADA guidelines at arrival of the patient to ED. Considering it as baseline values.
Hourly RBS, 2nd Hourly VBG for pH, anion gap and bicarbonate values, till resolution of DKA.
Resolution will be considered in correspondence to ADA guidelines for DKA. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of insulin infusion
New electrolytes changes |
Arrival to ED considered as baseline, & review after 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/10/2024 |
| Date of Study Completion (India) |
25/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/05/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Along with insulin therapy, intravenous fluid administration to expand intravascular, interstitial, and intracellular volume is a key component of the acute management of diabetic ketoacidosis (DKA).1-3 Saline (0.9% sodium chloride, also called normal saline) is the most commonly used fluid for this purpose and the primary fluid recommended in current DKA clinical practice guidelines.1-3 The chloride concentration in saline (154 mmol/L) is higher than that in human plasma (94-111 mmol/L), which can cause hyperchloremic metabolic acidosis, especially when administered in large volumes.4-7 Although the clinical outcomes of saline infusion remain incompletely understood, accumulating evidence suggests that saline may increase the risk of kidney injury and impair recovery from severe illness, possibly because of the induction of metabolic acidosis.8-13. Balanced salt solution(BSS), including Ringer lactate and Plasma-Lyte A contain chloride concentrations similar to those in human plasma and do not induce metabolic acidosis.4-7 Therefore, treatment of DKA with balanced salt solution rather than saline may lead to faster resolution of DKA.14-17 |