| CTRI Number |
CTRI/2023/01/048728 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
03/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational prospective study |
| Study Design |
Other |
|
Public Title of Study
|
Cardiac Arrhythmias in early ICU stay and mortality. |
|
Scientific Title of Study
|
Correlation between occurrence of new onset serious cardiac arrhythmias in first 48 hours of ICU admission and hospital outcome : A single centre prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAURABHKUMAR RAI |
| Designation |
DrNB resident. Critical care medicine |
| Affiliation |
Fortis Escorts Hospital , Faridabad, Haryana |
| Address |
Department of Critical Care Medicine, Second Floor, ICU, Fortis Escorts Hospital, New industrial town, Neelam Bata road, Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9960985711 |
| Fax |
|
| Email |
k.saurabh144@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Supradip Ghosh |
| Designation |
Director and Head, Department of Critical care medicine |
| Affiliation |
Fortis Escorts Hospital , Faridabad, Haryana |
| Address |
Department of Critical Care Medicine, 2nd Floor, ICU, Fortis Escorts Hospital, New industrial town, Neelam Bata road, Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9960985711 |
| Fax |
|
| Email |
intensivist1972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAURABHKUMAR RAI |
| Designation |
DrNB resident. Critical care medicine |
| Affiliation |
Fortis Escorts Hospital , Faridabad, Haryana |
| Address |
Department of Critical Care Medicine, 2nd Floor, ICU, Fortis Escorts Hospital, New industrial town, Neelam Bata road, Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9960985711 |
| Fax |
|
| Email |
k.saurabh144@gmail.com |
|
|
Source of Monetary or Material Support
|
| fortis hospitals limited, faridabad |
|
|
Primary Sponsor
|
| Name |
Fortis hospitals limited |
| Address |
Fortis escorts hospital
Neelam bata road Faridabad |
| 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 |
| Saurabhkumar Rai |
Fortis Escorts hospital |
2nd floor ,Department of critical care medicine
Faridabad
HARYANA |
9960985711
k.saurabh144@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Fortis Hospitals limited, neelam bata road Faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R008||Other abnormalities of heart beat, (2) ICD-10 Condition: R009||Unspecified abnormalities of heartbeat, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no intervention |
no intervention
observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted in ICU more than 18 years.
Patient expected to stay in ICU for at least 48 hours. |
|
| ExclusionCriteria |
| Details |
patients less than 18 years of age
Patients shifted in ICU for post-op observation |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Mortality and length of stay in ICU |
At ICU Discharge |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| hospital mortality and length of stay |
1 year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
06/01/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study title : Correlation between occurrence of new onset serious cardiac arrythmias in first 48 hours of ICU admission and hospital outcome :A single centre prospective observational study.
Study site : 18 bedded mixed ICU of Fortis Escorts hospital, Faridabad
Type of study : Single centre prospective observational study
Data collection : Baseline vital characteristics, patient history, provisional diagnosis, routine investigations and 12 lead electrocardiography will be documented for all admitted patients. APACHE II score will be calculated on admission to ascertain severity of illness.Continous ECG monitoring with bedside monitors attached will be done for each patient. All the departmental nursing staff will be trained to identify arrythmias based on basic characteristics like heart rate and rhythm.To decrease margin of error all tachycardias (heart rate >100) and bradycardias (heart rate <60) will be reported. Patients will be chronic arrythmias will be considered if a new and different type of arrythmia is detected.
Outcome measures :All patients expected to stay in ICU for atleast 48 hours will be observed for incidence of serious cardiac arrythmias. Rate of mortality at hospital discharge will be compared between arrythmic vs non arrythmic patients. Secondary outcome measures will be ICU mortality, ICU and hospital length of stay. |