| CTRI Number |
CTRI/2020/06/026152 [Registered on: 26/06/2020] Trial Registered Prospectively |
| Last Modified On: |
01/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Clinical Observational |
| Study Design |
Other |
|
Public Title of Study
|
COVID-19 in dialysis patients |
|
Scientific Title of Study
|
A study on outcome of COVID-19 infection in Haemodialysis patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tukaram Jamale |
| Designation |
Professor & Head |
| Affiliation |
Seth G.S.Medical College and KEM Hospital |
| Address |
Department of Nephrology,
Ward 34A,Old Hospital Building
Seth G.S.Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167460362 |
| Fax |
|
| Email |
tukaramjamale@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tukaram Jamale |
| Designation |
Professor & Head |
| Affiliation |
Seth G.S.Medical College and KEM Hospital |
| Address |
Department of Nephrology,
Ward 34A,Old Hospital Building
Seth G.S.Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167460362 |
| Fax |
|
| Email |
tukaramjamale@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayali Thakare |
| Designation |
Assistant Professor |
| Affiliation |
Seth G.S.Medical College and KEM Hospital |
| Address |
Department of Nephrology,
Ward 34A,Old Hospital Building
Seth G.S.Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9702841818 |
| Fax |
|
| Email |
thakare.sayali@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Nephrology, Seth G.S. Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-12 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Tukaram Jamale |
Seth G.S. Medical College and KEM Hospital |
Department of Nephrology,
Ward 34A, Old Hospital Building,3rd floor.
Seth G.S. Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-12
Mumbai
MAHARASHTRA |
9167460362
tukaramjamale@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC)- III, Seth G.S. Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with ESRD on Maintenance Haemo-dialysis admitted to KEM Hospital with the diagnosis of COVID-19 by CDC criteria
2. All age groups and both genders are to be included |
|
| ExclusionCriteria |
| Details |
1. Patients with incomplete medical records |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome of haemodialysis patients with covid 19 infection |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find clinical features, laboratory parameters and course of disease
2.To find any predictors or severity of disease |
3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
In Indian or International Journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The worldwide spread of the COVID-19 pandemic due to the novel SARS-CoV-2 virus, poses a
significant challenge to the medical fraternity today. This pandemic that has enveloped the globe, started as a local outbreak in the Chinese province of Wuhan in December 2019. Patients of Chronic kidney disease (CKD) are deemed as a population susceptible to COVID-19 illness. Especially patients of End-Stage Renal Disease (ESRD) on Maintenance Haemodialysis (MHD) are an especially vulnerable group since they are inherently involved in getting exposed to high-risk medical environments of dialysis units for the purpose of scheduled dialysis treatments. The behavior of COVID-19 illness in dialysis patients has not been studied systematically, due to the present circumstances of unprecedented crisis. This crucial acquisition of information will lead to better understanding and management of these patients during this pandemic crisis. Mumbai, one of the largest epicenter of the disease in our country, has a large dialysis population currently facing this challenge. Our study aims to scientifically look at the presentation, clinical features, laboratory parameters and outcomes of such patients on haemodialysis in Mumbai who are admitted to KEMH with COVID-19 positive status. The analysis of this data will be of the utmost use to
patient care. |