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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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