| CTRI Number |
CTRI/2023/06/053513 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
31/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ELECTROLYTE STATE & OUTCOME IN SEVERE COVID-19 DISEASE |
|
Scientific Title of Study
|
Assessment of Clinical Characteristics, Electrolyte Imbalance & Outcome in Patients Hospitalized in Intensive Care Unit with Severe Covid-19 Disease - A Single Centered Retrospective Observational Study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR JOSHI SUCHITA ANNASAHEB |
| Designation |
ASSOCIATE PROFESSOR ANAESTHESIOLOGY |
| Affiliation |
GOVT. MEDICAL COLLEGE & HOSPITAL, AURANGABAD |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, GMCHA Panchakki Road Aurangabad MAHARASHTRA 431001 India |
| Phone |
9422777903 |
| Fax |
-- |
| Email |
suchita_khadke@rediffmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR JOSHI SUCHITA ANNASAHEB |
| Designation |
ASSOCIATE PROFESSOR ANAESTHESIOLOGY |
| Affiliation |
GOVT. MEDICAL COLLEGE & HOSPITAL, AURANGABAD |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, GMCHA Panchakki Road
MAHARASHTRA 431001 India |
| Phone |
9422777903 |
| Fax |
-- |
| Email |
suchita_khadke@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR JOSHI SUCHITA ANNASAHEB |
| Designation |
ASSOCIATE PROFESSOR ANAESTHESIOLOGY |
| Affiliation |
GOVT. MEDICAL COLLEGE & HOSPITAL, AURANGABAD |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, GMCHA Panchakki Road
MAHARASHTRA 431001 India |
| Phone |
9422777903 |
| Fax |
-- |
| Email |
suchita_khadke@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| The Dean, Govt. Medical College and Hospital, Aurangabad. |
|
|
Primary Sponsor
|
| Name |
The Dean, GMCHA |
| Address |
GOVT. MEDICAL COLLEGE & HOSPITAL, PANCHAKKI rOAD, AURANGABAD. |
| 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 JOSHI SUCHITA ANNASAHEB |
Govt. Medical College and Hospital, Aurangabad. |
SUPERSPECIALITY BLOCK & MEDICINE BUILDING COVID INTENSIVE CARE UNIT, Panchakki Road, Aurangabad Aurangabad MAHARASHTRA |
9422777903 -- suchita_khadke@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U071||COVID 19 virus identified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOT APPLICABLE |
NOT APPLICABLE |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male & female patients confirmed by the real-time PCR/Rapid antigen test on the respiratory tract samples as positive of SARS-CoV-2
2. Patients hospitalized in dedicated Covid-19 intensive care unit.
|
|
| ExclusionCriteria |
| Details |
1. Patients who had other causes of electrolyte disturbance
2. Chronic organ dysfunction (e.g., hepatic or renal dysfunction),
3. Terminal cancer immunodeficiency
4. Patients with a history of long-term use of hormones & diuretics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between the level of the electrolyte disturbances and the morbidity and mortality in patients hospitalized in intensive care unit with severe Covid -19 disease |
1. Discharge from intensive care unit
2. Death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Acid base disturbances on admission & outcome
Prognostic factors associated with disease progression & mortality risk
-clinical course & outcome |
1. Discharge from intensive care unit
2. Death |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
10/06/2023 |
| 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="0" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Electrolyte disturbances have important implications not only for patient management but also for identifying & better understanding of potential pathophysiologic mechanisms underlying COVID-19. A single-center, retrospective, observational study will be carried out to find any correlation between the level of the electrolyte disturbances and the morbidity and mortality, acid base disturbances on admission & outcome, prognostic factors associated with disease progression & mortality risk in patients hospitalized in intensive care unit with severe Covid -19 disease This study will follow the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. Male & female patients 18-65 years old who were confirmed by the real-time PCR/Rapid antigen test on the respiratory tract samples as positive of SARS-CoV-2. hospitalized in intensive care unit from 1 July 2020 until 31 October 2020 died and recovered with Covid-19 disease will be collected retrospectively & analyzed. Data on age, sex, laboratory values during admission (hemoglobin concentration, lymphocyte count, platelet count, arterial blood gas analysis, markers of inflammation, serum and urine creatinine, urea, serum and serum and urine electrolyte), comorbidities, sign and symptoms at presentation, vital signs, administered treatment (diuretics, electrolyte supplement), as well as the admission in ICU. |