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CTRI Number  CTRI/2019/10/021594 [Registered on: 10/10/2019] Trial Registered Prospectively
Last Modified On: 12/01/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   a comparison of hemoglobin and electrolyte level tested by a machine in emergency department and central laboratory 
Scientific Title of Study   Point of care versus central laboratory measurements of electrolytes and hemoglobin: A Prospective observational study in critically ill patients at Aiims Bhubaneswar 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
not applicable  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeeta Sahoo 
Designation  Assistant Professor, Department of Trauma And Emergency 
Affiliation  AIIMS BHUBANESWAR 
Address  Room no-5, 5th floor,Hospital Block,Aiims Bhubaneswar
Emergency Department AIIMS Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  2472312  
Fax    
Email  drsangeeta.asth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sangeeta Sahoo 
Designation  Assistant Professor, Department of Trauma And Emergency 
Affiliation  AIIMS BHUBANESWAR 
Address  Room no-5, 5th floor,Hospital Block,Aiims Bhubaneswar
Emergency Department, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  2472312  
Fax    
Email  drsangeeta.asth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sangeeta Sahoo 
Designation  Assistant Professor, Department of Trauma And Emergency 
Affiliation  AIIMS BHUBANESWAR 
Address  Room no-5, 5th floor,Hospital Block, AIIMS Bhubaneswar
Emergency Department, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  2472312  
Fax    
Email  drsangeeta.asth@gmail.com  
 
Source of Monetary or Material Support  
AIIMS BHUBANESWAR,ODISHA 
 
Primary Sponsor  
Name  Investigator Initiated 
Address  Department of Trauma and Emergency, AIIMS BHUBANESWAR 
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 SANGEETA SAHOO  AIIMS BHUBANESWAR  Room No-5, Hospital Block, AIIMS Bhubaneswar.
Khordha
ORISSA 
9556547655

drsangeeta.asth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, AIIMS BHUBANESWAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R69||Illness, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  critically ill patients coming to emergency department of age 18 years to 80 years.
patients who are give consent to take participitate in the study
 
 
ExclusionCriteria 
Details  patients of less than 18 years .
patients age of more than 80 years.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This prospective study will be performed to determine whether the VBG and laboratory measurements of potassium, sodium, and hemoglobin levels are equivalent, and Whether ABG analyzer can be used to guide clinical care before the laboratory results become available.

 
at the time of patient arrival  
 
Secondary Outcome  
Outcome  TimePoints 
This prospective study will be performed to determine whether the VBG and laboratory measurements of potassium, sodium, and hemoglobin levels are equivalent, and Whether ABG analyzer can be used to guide clinical care before the laboratory results become available.

 
at the time of patient arrival 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="206" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/10/2019 
Date of Study Completion (India) 12/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Electrolyte abnormalities can precipitate life threating events. Critical ill patients require urgent evaluation of electrolyte to initiate therapy. In such situation, rapid and accurate assessment of electrolyte abnormality may enable the institution focused therapies. The rapidity of such assessment, particularly in developing countries, is often delayed in transporting samples to the central laboratory either due to lack of sufficient number of manpower, or the absence of rapid transit system (RTS). These delays could unfavorably impact outcomes. Moreover, it is important to measure the electrolyte and hemoglobin level in older patients, patients with renal dysfunction, patients who are taking diuretics. In addition, the patients with severe anemia are waiting for the blood transfusion treatment and those with hyperkalemia need reduce the serum potassium level immediately. Such biomarker information can be quickly obtained by point of care testing(POCT)with an arterial blood gas analyzer. Thus, emergency management can be quickly performed.    Point of care testing (POCT) has thus been increasingly used in the Emergency department (ED) and ICU to enable the rapid assessment of electrolyte and arterial blood gas (ABG) abnormalities. Despite the advantage of a rapid turnaround time with POCT, concerns have been raised regarding the accuracy and reliability of POCT devices. Conflicting results from various studies, probably due to the use of different device, add to the concerns. While some studies concluded that results differed significantly for plasma sodium and chloride concentrations, other also found significant difference in potassium value. Thus, it is not uncommon to find clinician using the POCT results to act in an emergent situation while sending an additional sample to the central laboratory to confirm the POCT value. The difference in the value obtained have been attributed to the use of different devices, the effect of transport of sample as well as the type of sample used. This prospective study will be performed to determine whether the VBG and laboratory measurements of potassium, sodium, and hemoglobin levels are equivalent, and Whether ABG analyzer can be used to guide clinical care before the laboratory results become available.

 
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