| CTRI Number |
CTRI/2024/09/074017 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see the effects of new onset irregular heart beat on the mortality in critically ill medical ICU patients |
|
Scientific Title of Study
|
New onset arrhythmias in critically ill medical patients- patient profile, ICU course and outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Upmanyoo |
| Designation |
DrNB resident |
| Affiliation |
MAX Super Speciality hospital, Saket, New Delhi |
| Address |
Department of Critical Care Medicine
MAX Super Speciality hospital, Press Enclave Road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9896737514 |
| Fax |
|
| Email |
pooja.upmanyoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Omender Singh |
| Designation |
Principal Director |
| Affiliation |
MAX Super Speciality hospital, Saket, New Delhi |
| Address |
Department of Critical Care Medicine
MAX Super Speciality hospital, Press Enclave Road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9810734246 |
| Fax |
|
| Email |
omender.singh@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Omender Singh |
| Designation |
Principal Director |
| Affiliation |
MAX Super Speciality hospital, Saket, New Delhi |
| Address |
Department of Critical Care Medicine
MAX Super Speciality hospital, Press Enclave Road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9810734246 |
| Fax |
|
| Email |
omender.singh@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Department of critical care medicine
MAX Superspeciality hospital
,press enclave road, saket, new delhi, 110017
|
|
|
Primary Sponsor
|
| Name |
max superspeciality hospital |
| Address |
Department of Critical Care Medicine,MAX Super Speciality hospital,Press Enclave Road, Saket, New Delhi, 110017 |
| 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 pooja upmanyoo |
Department of Critical Care Medicine, max superspeciality hospital |
MICU, West Block, Department of Critical Care Medicine, Max Super Speciality Hospital, Press Enclave road, Saket, New Delhi-110017
South
DELHI |
9896737514
pooja.upmanyoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I442||Atrioventricular block, complete, (2) ICD-10 Condition: I440||Atrioventricular block, first degree, (3) ICD-10 Condition: I441||Atrioventricular block, second degree, (4) ICD-10 Condition: I484||Atypical atrial flutter, (5) ICD-10 Condition: I443||Other and unspecified atrioventricular block, (6) ICD-10 Condition: I498||Other specified cardiac arrhythmias, (7) ICD-10 Condition: I458||Other specified conduction disorders, (8) ICD-10 Condition: I480||Paroxysmal atrial fibrillation, (9) ICD-10 Condition: I479||Paroxysmal tachycardia, unspecified, (10) ICD-10 Condition: I481||Persistent atrial fibrillation, (11) ICD-10 Condition: I470||Re-entry ventricular arrhythmia, (12) ICD-10 Condition: I495||Sick sinus syndrome, (13) ICD-10 Condition: I471||Supraventricular tachycardia, (14) ICD-10 Condition: I483||Typical atrial flutter, (15) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, (16) ICD-10 Condition: I490||Ventricular fibrillation and flutter, (17) ICD-10 Condition: I472||Ventricular tachycardia, |
|
|
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 |
All patients with new onset arrhythmia after admission to general medical ICU.
All study subjects who are willing to give informed consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with baseline chronic arrhythmia.
2.Arrhythmias and other waveforms which occur during ACLS or chest compressions will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the ICU course and outcomes in terms of ICU mortality of patients developing new onset arrhythmias in medical ICU. |
till discharge/LAMA/death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Probable causes of new onset arrhythmias
2.Length of hospital and ICU stay
|
Till discharge/LAMA/death |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
25/09/2024 |
| 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="2"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 clinical events in the intensive care unit (ICU) setting. The frequency and prognosis associated with arrhythmias vary according to the clinical setting in which they occur. Arrhythmias have been reported to occur in 15.7 and 19.7 % of patients in the surgical and medical ICU settings, respectively. In one epidemiologic study of critically ill patients, it was reported to be as high as 78 %. Nevertheless, the clinical impact of many arrhythmias in the continuum of critical illness is somewhat unclear. In some studies, arrhythmias have been implicated as a marker of disease severity in critically ill patients. They have also been associated with increased length of stay in the ICU, worse clinical outcome, and increased mortality. The clinical course of patients receiving care in the medical ICU is usually complex in nature with the presence of multiple concomitant insults to target organs in the form of renal, cardiac, and pulmonary illness. The majority of published studies evaluating the prevalence and relevance of arrhythmias in critically ill patients focus on cardiac vs. non-cardiac surgical patients, while data in the setting of a general medical ICU is less abundant. Our study is focused on medical ICU patients who develop new onset arrhythmias and is aimed to elucidate the probable causes, the type of arrhythmias, management and outcomes of these patients in terms of length of hospital stay and ICU mortality. |