| CTRI Number |
CTRI/2026/02/103181 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Ringers lactate vs Normal saline for faster recovery in Diabetic ketoacidosis patients |
|
Scientific Title of Study
|
Time to Resolution of Diabetic Ketoacidosis by Ringers Lactate Solution Versus Normal Saline An open labelled Randomised Controlled 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 |
Dr Debananda Sahoo |
| Designation |
Associate Professor, Dept of General Medicine, AIIMS Bhubaneswar |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Department of General Medicine,AIIMS,BBSR
Khordha ORISSA 751019 India |
| Phone |
8763290804 |
| Fax |
|
| Email |
genmed_debananda@aiimsbhubaneswar.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Debananda Sahoo |
| Designation |
Associate Professor, Dept of General Medicine, AIIMS Bhubaneswar |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Department of General Medicine,AIIMS,BBSR
Khordha ORISSA 751019 India |
| Phone |
8763290804 |
| Fax |
|
| Email |
genmed_debananda@aiimsbhubaneswar.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Debananda Sahoo |
| Designation |
Associate Professor, Dept of General Medicine, AIIMS Bhubaneswar |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Department of General Medicine,AIIMS,BBSR
Khordha ORISSA 751019 India |
| Phone |
8763290804 |
| Fax |
|
| Email |
genmed_debananda@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhubaneswar
It is a tertiary care government hospital.Hence the required intervention and comparator agents are available under hospital supply |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Sijua Patrapada Bhubaneswar Odisha |
| 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 Anuradha Sahoo |
All India Institute of Medical Sciences Bhubaneswar |
Wards D6,E6, F6, MICU under Department of General Medicine & Dept of Emergency Medicine Khordha ORISSA |
08658196300
anuradha13sahoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Bhubneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E131||Other specified diabetes mellituswith ketoacidosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Normal Saline |
All patients presenting to the ER with moderate to severe DKA will be taken for the study as per the inclusion and exclusion criteria.
DKA will be diagnosed as per ADA guidelines.Only moderate and severe DKA will be taken for the study.
Consent will be taken from legally responsible attendant of the patient as moderate to severe DKA patients would most likely present in a stuporous or comatose state.
The patients are then divided into 2 groups by computer generated 1:1 randomisation.
The patient then receives fluids(RL or NS) as per the allotted group.In the NS group
IV fluid NS is to be given as per a standard protocol as given below:-
24 hours fluid replacement:-
1)IV fluid 30ml/kg to be given stat followed by 500ml/hr for 8 hrs followed by 250ml/hr for next 16 hrs followed by 150ml/hr till DKA resolves.
IVF 5% dextrose to be started when RBS 250mg/dl and insulin infusion to be titrated to maintain RBS (150-250) mg/dl.
Extra bolus of fluid(500ml) to be given if pH is not improving or fall in RBS is not adequate(expected fall in RBS –(50-100)mg/hr)
ABG and RBS to be done every two hourly.
|
| Intervention |
Ringers Lactate |
All patients presenting to the ER with moderate to severe DKA will be taken for the study as per the inclusion and exclusion criteria. DKA will be diagnosed as per ADA guidelines.Only moderate and severe DKA will be taken for the study. Consent will be taken from legally responsible attendant of the patient as moderate to severe DKA patients would most likely present in a stuporous or comatose state. The patients are then divided into 2 groups by computer generated 1:1 randomisation. The patient then receives fluids(RL or NS) as per the allotted group.In the RL group IV fluid RL is to be given as per a standard protocol as given below:- 24 hours fluid replacement:- 1)IV fluid 30ml/kg to be given stat followed by 500ml/hr for 8 hrs followed by 250ml/hr for next 16 hrs followed by 150ml/hr till DKA resolves. IVF 5% dextrose to be started when RBS 250mg/dl and insulin infusion to be titrated to maintain RBS (150-250) mg/dl. Extra bolus of fluid(500ml) to be given if pH is not improving or fall in RBS is not adequate(expected fall in RBS –(50-100)mg/hr) ABG and RBS to be done every two hourly. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1)Age more than 16 years
2)Diagnosed as moderate or severe DKA
3)Has not received any fluid or insulin therapy before reaching to our hospital
|
|
| ExclusionCriteria |
| Details |
1)Patients with mild DKA
2)All patients who have received fluid or insulin therapy earlier in outside hospital
3)Patients diagnosed as Hyperglycaemic Hyperosmolar state.
4)Expired or discharged prior to DKA resolution |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the time taken for resolution of DKA
|
To measure the time taken for resolution of DKA
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the insulin requirement for resolution of DKA |
At day 5 |
| To measure the length of ICU stay & hospital stay |
At day 28 |
| To measure the in-hospital mortality rate |
At day 28 |
| To measure the total requirement of IV fluids |
At day 7 |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2026 |
| 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)
|
Not Yet Recruiting |
| 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
|
The prevalence of diabetes in worldwide is estimated to be 10.5% of adults aged 20-79 years (around 537million) in 2021.This is expected to rise to 643million in 2030 and 783 million in 2045. DKA is a life-threatening complication of diabetes that can occur in both individuals affected by TYPE I AND TYPE II DM. It is a condition of absolute or near absolute insulin deficiency characterized by hyperglycaemia, ketone body formation and acidosis. Prevalence of DKA in diabetics varies depending on the type of diabetes, patient’s age, insulin type, race, ethnicity, etc. Incidence of DKA in type 1 DM is roughly estimated to be around 1 out of 2000. (About 3% of patients of T1DM initially present as DKA) .There is also an increase of incidence of DKA in type 2DM (Ketosis prone type 2DM, also known as Flatbush diabetes) For the management of DKA, it is necessary to replenish the fluid deficit, correct the electrolyte imbalance, insulin therapy along with treatment of the precipitating factors Fluid replacement therapy should be the first and most important therapeutic measure in DKA even before initiaton of insulin. Typical fluid loss in DKA is estimated to be around 100ml/kg which is about 7L in a 70 kg individual. Current guidelines recommend 0.9% Sodium chloride as the replacement fluid of choice and is widely preferred because of its effective restoration of fluid deficit and easy availability, however because of its higher chloride content, it is also associated with hyperchloremia causing NAGMA (normal anion gap metabolic acidosis), thus prolonging the time taken to resolution of DKA, thereby leading to prolonged hospital stay. After the initial resuscitation, in patients with normal or high sodium levels, fluids are switched to 0.45% NaCl. Various studies have demonstrated the faster resolution of acidosis with balanced crystalloid solutions as compared to 0.9% saline. Previous studies have shown the use of Sterofundin being associated with earlier resolution of DKA, lesser IV fluid requirement, lesser IV insulin requirement, and less requirement of 0.45%NS with shorter hospital stay. Although NS is more commonly used because of its easy availability, it carries a higher risk of hyperchloremic metabolic acidosis which further prolongs the resolution of acidosis Currently the controversy revolves around selecting either Normal Saline or Balanced Electrolyte Solution (such as Lactated Ringer’s solution, Sterofundin or PlasmaLyte) Electrolyte contents of RL closely resemble those of plasma, hence can be rapidly infused without risk of causing any electrolyte imbalances. Lactate in RL is metabolised and converted to bicarbonate by liver which makes it valuable for treatment of metabolic acidosis. Our study aims at comparing the difference in outcome on using 0.9% saline and ringer’s lactate by using primary and secondary objectives
| |