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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  
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 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  
Status 
Not Applicable 
 
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.

 
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