| 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
|
|
|
Primary Sponsor
|
| Name |
Investigator Initiated |
| Address |
Department of Trauma and Emergency,
AIIMS BHUBANESWAR |
| 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 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
|
|
|
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. |