| CTRI Number |
CTRI/2024/10/075623 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Rhythm abnormalities in Critically ill patients |
|
Scientific Title of Study
|
A Prospective observational study on new onset arrythmias in critically ill patients admitted to multidisciplinary intensive care unit (ICU) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Haripriya V |
| Designation |
Post graduate student |
| Affiliation |
Sri Ramachandra Institue of higher Education and Registration |
| Address |
Department of critical care Medicine,Sri Ramachandra Institue of higher education and research,porur,chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
7708982896 |
| Fax |
|
| Email |
phari8806@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baby Sailaja K |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department Of Critical Care Medicine, Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai
TAMIL NADU
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9600153482 |
| Fax |
|
| Email |
babysailaja.k@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr MK Renuka |
| Designation |
Professor and Head Of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department Of Critical Care Medicine, Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai
Chennai
TAMIL NADU
600116
India
Chennai
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research Porur ,Chennai, Tamil Nadu, India - 600116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute Of Higher Education And Research Porur ,Chennai |
| 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 Baby Sailaja K |
Sri Ramachandra Institute of Higher Education and Research |
Department Of Critical Care Medicine, Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai
Chennai
TAMIL NADU
600116
India
Thiruvallur
TAMIL NADU |
09600153482
babysailaja.k@sriramachandra.edu.in |
|
|
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: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patient admitted to adult intensive care unit.
Age more than 18 years.
New onset of Arrhythmias.
Lasts more than 2 minutes be able to documented of 12 lead ECG. |
|
| ExclusionCriteria |
| Details |
Patient with unknown and undefined arrhythmias of known premorbid condition.
Known Arrhythmias.
Lasting less than 30 seconds not able to do ECG.
Patients with known Valvular Heart Disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Arrythmias in intensive care unit |
Six Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic instability in Intensive care uint, whether the patients need vasopressor recovery or ventilator support in lenght of stay in Intensive care uint |
Six Months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Arrhythmias are common in critically ill patients and their clinical manifestation may range from patients being completely asymptomatic to cardiorespiratory arrest. The underlying causes are often multifactorial, hence the management and resuscitation of patients must be performed in a systematic and methodical manner. The aim of this article is to provide a framework for the appropriate management of the more frequently encountered cardiac arrhythmias in the critically ill .Arrhythmias are common in critically ill patients and their clinical manifestation may range from patients being completely asymptomatic to cardiorespiratory arrest. The underlying causes are often multifactorial, hence the management and resuscitation of patients must be performed in a systematic and methodical manner. The aim of this article is to provide a framework for the appropriate management of the more frequently encountered cardiac arrhythmias in the critically ill. |