| CTRI Number |
CTRI/2021/08/035579 [Registered on: 11/08/2021] Trial Registered Prospectively |
| Last Modified On: |
10/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out the incidence and risk factors related to Arrhythmias in ICU |
|
Scientific Title of Study
|
Study of incidence, Risk Factors and Outcome of Arrhythmias in Medical Intensive Care Unit |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashreen Kaur |
| Designation |
DrNB Critical Care Medicine Resident |
| Affiliation |
Max Superspeciality Hospital |
| Address |
Department of Pulmonary and Critical Care Medicine, Medical Intensive Care Unit, Second Floor, Max Superspeciality Hospital,Phase 6, Mohali
Rupnagar
PUNJAB
160055
India |
| Phone |
9501488455 |
| Fax |
|
| Email |
cuteash89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Bhasin |
| Designation |
Director and Head of Department |
| Affiliation |
Max Superspeciality Hospital |
| Address |
Max Superspeciality Hospital,Phase 6, Mohali
Rupnagar
PUNJAB
160055
India |
| Phone |
9779950888 |
| Fax |
|
| Email |
bhasin.ccm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashreen Kaur |
| Designation |
DrNB Critical Care Medicine Resident |
| Affiliation |
Max Superspeciality Hospital |
| Address |
Department of Pulmonary and Critical Care Medicine, Medical Intensive Care Unit, Second Floor, Max Superspeciality Hospital,Phase 6, Mohali
Rupnagar
PUNJAB
160055
India |
| Phone |
9501488455 |
| Fax |
|
| Email |
cuteash89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Superspeciality Hospital, Mohali,Punjab |
|
|
Primary Sponsor
|
| Name |
Max Superspeciality Hospital |
| Address |
Phase 6, Mohali |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ashreen Kaur |
Max Superspeciality Hospital, Mohali |
Department of Pulmonary and Critical Care Medicine, Medical Intensive Care, Second Floor
Rupnagar
PUNJAB |
9501488455
cuteash89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Max Superspeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.90 Year(s) |
| Gender |
Both |
| Details |
1. All adult patients admitted to medical ICU with a new onset arrhythmia.
2. Arrhythmias directly triggering cardiac decompensation and ACLS
3. Patients requiring ICU stay of at least 24 hours. |
|
| ExclusionCriteria |
| Details |
1. Patients with chronic arrhythmias
2. Patients with a permanent pacemaker or an implantable cardioverter defibrillator in situ.
3. Arrhythmias present during ACLS or chest compressions. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Incidence of arrhythmias in ICU
2. Risk factors for arrhythmias
3. Morbidity and mortality related to arrhythmias |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of arrhythmias in cardiac patients admitted to ICU
Incidence of arrhythmias in patients with Severe Covid-19 |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/08/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It’s a prospective observational study to look for the incidence of arrhythmias in ICU and to find the risk factors associated with its occurrence. It will help us reduce further morbidity and mortality attributed to arrhythmias. |