| CTRI Number |
CTRI/2024/12/077863 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized control trial to study which crystalloid (normal saline or ringer lactate) is better for treating diabetic ketoacidosis.
|
|
Scientific Title of Study
|
To compare the effect of Normal Saline vs Ringer Lactate on resolution time of biochemical parameters in patients presenting to Department of Trauma and Emergency with Diabetic Ketoacidosis : A Randomized Control 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 |
Ashok Choudhary |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Trauma and Emergency, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, Basni, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9664029363 |
| Fax |
|
| Email |
ashokchoudhary1a1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manisha Jhirwal |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
| Address |
Department of Trauma and Emergency, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7042657811 |
| Fax |
|
| Email |
ecstatic.manisha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashok Choudhary |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Trauma and Emergency, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9664029363 |
| Fax |
|
| Email |
ashokchoudhary1a1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Trauma and Emergency, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, Basni, Jodhpur, Rajasthan, Pin code - 342005, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Marudhar Industrial Area, 2nd Phase,Basni, Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ashok Choudhary |
All India Institute of Medical Sciences, Jodhpur |
Marudhar Industrial Area, 2nd Phase, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN |
9664029363
ashokchoudhary1a1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Jodhpur Institutional Ethics Committee (Clinical Trial) |
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, (2) ICD-10 Condition: E101||Type 1 diabetes mellitus with ketoacidosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.9% Normal saline |
Dose- 3 liters in first 2.5 hrs followed by 150 ml/hr;
Frequency- Continous administration;
Route- Intravenous;
Duration- Until the resolution 0f Diabetic Ketoacidosis
|
| Comparator Agent |
Ringer lactate |
Dose- 3 liters in first 2.5 hrs followed by 150 ml/hr;
Frequency- Continous administration;
Route- Intravenous;
Duration- Until the resolution 0f Diabetic Ketoacidosis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Meeting laboratory diagnostic criteria of diabetic ketoacidosis (As per ADA)
Blood glucose greater than or equal to 250 mg/dl.
pH less than 7.3.
Bicarbonate less than18 mEq/L.
Blood Ketones greater than or equal to 3.0 mmol/L.
|
|
| ExclusionCriteria |
| Details |
Patients with cardiogenic shock
Patients with CKD
Patients with CLD
Pregnant patients
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for resolution of biochemical parameters in groups receiving normal saline vs ringer lactate. |
Time taken until resolution of Diabetes Ketoacidosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in chloride, bicarbonate, pH levels over time |
Time taken for resolution of Diabetic ketoacidosis |
| Comparison of effect on clinical parameters in both study groups |
Time taken for resolution of Diabetic ketoacidosis |
| Incidence of hyper/hypokalemic events during study interval. |
Time taken for resolution of Diabetic ketoacidosis |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2024 |
| Date of Study Completion (India) |
25/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/05/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Through publications, physically as well as electronically
- For how long will this data be available start date provided 01-11-2026 and end date provided 01-10-2099?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Diabetic ketoacidosis (DKA) is an acute, life threatening complication of diabetes requiring replacement of fluid losses with IV fluids, correction of hyperglycemia with appropriate administration of insulin, correction of electrolyte losses, detection of precipitating causes and maintenance insulin to prevent recurrence. In adult subjects with DKA, the overall mortality is <1%; however, a mortality of > 5 % has been reported in the elderly and in patients with concomitant life threatening illnesses. Current DKA treatment guidelines recommend normal saline (NS-0.9% sodium chloride) for resuscitation and treatment of DKA. Normal saline administration causes hyperchloremic metabolic acidosis, which is associated increased incidences of AKI. This study aims to find which IV fluid administration leads to faster resolution of diabetic ketoacidosis among normal saline and ringer lactate; as its primary objective. As its secondary objectives this study aims to to find changes in metabolic and clinical parameters over period of time and incidences of hyperkalemia episodes, during treatment using either fluid. |