| CTRI Number |
CTRI/2026/03/105980 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Looking at blood phosphorus levels to predict how fast a patient recovers from Diabetic Ketoacidosis (DKA) |
|
Scientific Title of Study
|
A Study on Serum Phosphorus Levels as a Prognostic Indicator in the Management of Diabetic Ketoacidosis |
| 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. Kavita Jain |
| Designation |
Professor and Head of Department |
| Affiliation |
DEPARTMENT OF EMERGENCY MEDICINE |
| Address |
Department of Emergency Medicine
JLN Medical College and Associated Hospital
Ajmer
Department of Emergency Medicine
JLN Medical College and Associated Hospital
Ajmer – 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Badri Prasad Yadav |
| Designation |
PG Resident |
| Affiliation |
Department of Emergency Medicine |
| Address |
Department of Emergency Medicine
JLN Medical College and Associated Hospital
Ajmer
JLN Medical College and Associated Hospital
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
7737489197 |
| Fax |
|
| Email |
Yadavbp15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BADRI PRASAD YADAV |
| Designation |
Pg resident |
| Affiliation |
Department of emergency medicine jln medical college and associated hospital ajmer 305001 |
| Address |
Department of emergency medicine
J L N medical college and associated hospital ajmer 305001
J L N medical collage ajmer 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
7737489197 |
| Fax |
|
| Email |
Yadavbp15@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN Medical College and Associated Hospitals, Ajmer, Rajasthan – 305001, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College and Associated Hospitals Ajmer |
| Address |
Jawaharlal Nehru Medical College and Associated Hospitals
Ajmer, Rajasthan – 305001
India |
| 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 KAVITA JAIN |
JLN Medical College and Associated Hospitals, Ajmer |
Department of Emergency Medicine
JLN Medical College and Associated Hospitals
Ajmer, Rajasthan – 305001
India
Ajmer
RAJASTHAN |
9414006151
drkavitajain15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,JAWAHARLAL NEHRU MEDICAL COLLEGE AJMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R739||Hyperglycemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1)patients who have given written informed consent
2)patients with diabetic keto acidosis
3)patients who are equal or more then 18yrs old |
|
| ExclusionCriteria |
| Details |
Patients who have not given written informed consent.
Patients with malnutrition, malabsorption syndromes.
Patients on diuretics, steroids, phosphate binding antacids.
Patients with renal transplantation.
Patients with hyperparathyroidism.
Patients with pancreatitis, burns, volume expansion.
Patients who are alcoholics.
Respiratory alkalosis –hyperventilation, panic attacks, salicylate poisoning
Rapid cellular uptake –refeeding syndrome, leukemic blast cell crises, hungry bone syndrome.
Patients with Type 1 diabetes mellitus and other causes of ketoacidosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of serum phosphorus level with severity of diabetic ketoacidosis. |
Baseline (at admission), 24 hours after admission, and at discharge/final outcome. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between Serum Phosphorus and Serum Potassium levels during the first 24 hours of management |
Measured at 0, 6, 12, and 24 hours. |
| Duration of Intensive Care Unit (ICU) stay |
From admission until ICU discharge. |
| Incidence of hypophosphatemia-related complications (e.g., muscle weakness, cardiac arrhythmias, or requirement for mechanical ventilation). |
From admission until hospital discharge. |
| Requirement for intravenous phosphate replacement therapy. |
During the first 48 hours of treatment. |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
23/03/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Background: Diabetic Ketoacidosis (DKA) is a life-threatening endocrine emergency. Phosphorus depletion is a hallmark of DKA, often masked by initial hyperphosphatemia. During treatment with insulin and fluids, serum phosphorus levels frequently plummet , which may lead to complications like respiratory muscle weakness, arrhythmias, and prolonged recovery. Objective: The primary objective of this study is to evaluate the role of admission and nadir Serum Phosphorus levels as prognostic indicators in the management of DKA, specifically correlating these levels with the time taken for DKA resolution. Methods: This is a Prospective Observational study conducted on 130 adult patients diagnosed with DKA. Upon admission, baseline clinical parameters and Serum Phosphorus levels will be recorded. Patients will be managed as per standard protocol. Serum phosphorus will be serially monitored at [e.g., 0, 6, 12, and 24 hours]. Outcome: The study will analyse the correlation between phosphorus levels and DKA severity, the duration of ICU stay, and the time taken for biochemical resolution (pH > 7.3 and Bicarbonate > 15 mmol/L). |