| CTRI Number |
CTRI/2020/01/022913 [Registered on: 22/01/2020] Trial Registered Prospectively |
| Last Modified On: |
05/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the nature,mechanism and common drug class involved in possible drug-drug interactions in emergency medicine department patients admitted for at least two days in emergency department wards. |
|
Scientific Title of Study
|
A Prospective Study of Drug-Drug Interactions in Emergency Medicine Department in a Tertiary Care Hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KIMS/IEC/D94/2018 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMahesh kumar M K |
| Designation |
MD Pharmacology student cum tutor |
| Affiliation |
Kempegowda Institute of Medical Sciences |
| Address |
MD Pharmacology student cum tutor,Kempegowda Institute of Medical Sciences,Banashankari 2nd stage,Bangalore-560070,Karnataka,India.
MD Pharmacology student cum tutor,Kempegowda Institute of Medical Sciences,Banashankari 2nd stage,Bangalore-560070,Karnataka,India.
Bangalore
KARNATAKA
560070
India |
| Phone |
9961939267 |
| Fax |
|
| Email |
mkmkoroth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVasundaraK |
| Designation |
Professor of Pharmacology and Guide |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,BANGALORE-560070 |
| Address |
Dr.Vasundara.K,Professor of Pharmacology,Department of Pharmacology,Kempegowda Institute of Medical Sciences,Bangalore-560070,Karnataka,India
Dr.Vasundara.K,Professor of Pharmacology,Department of Pharmacology,Kempegowda Institute of Medical Sciences,Bangalore-560070,Karnataka,India
Bangalore
KARNATAKA
560070
India |
| Phone |
9480333963 |
| Fax |
|
| Email |
vasundarakrishnaiah@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrMAHESH KUMARMK |
| Designation |
MD PHARMACOLOGY STUDENT CUM TUTOR |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,BANGALORE-560070 |
| Address |
ROOM NO.206,CT BED,2ND MAIN,3RD CROSS,THYAGARAJANAGAR,
BANGALORE-560028
MD PHARMACOLOGY STUDENT CUM TUTOR,KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, BANGALORE-560070
Bangalore
KARNATAKA
560028
India |
| Phone |
9961939267 |
| Fax |
|
| Email |
mkmkoroth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Emergency Department,Kempegowda Institute of Medical Sciences&Research Centre,V V Puram,Bangalore-560004,Karnataka. |
|
|
Primary Sponsor
|
| Name |
Kempegowda Institute of Medical Sciences |
| Address |
Kempegowda Institute of Medical Sciences,Banashankari 2nd stage,Bangalore-560070,Karnataka,India. |
| Type of Sponsor |
Private medical college |
|
|
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 Mahesh kumar M K |
Kempegowda Institute of Medical Sciences Hospital&Research Centre,Bangalore-560004 |
Department of Emergency Medicine
Bangalore
KARNATAKA |
9961939267
mkmkoroth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1).Patients admitted to emergency medicine department for minimum 48 hours
2).Subjects receiving two or more drugs
3).Willingness of patients/legal representatives to give written informed consent
4).All patients admitted to emergency medicine department aged 18 years and above |
|
| ExclusionCriteria |
| Details |
1.Patient not willing to give informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To generate valid and useful DDIs data in Emergency Medicine department |
At the end of study-1year 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify common drug class involved in drug-drug interactions |
1.5yrs |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/01/2020 |
| Date of Study Completion (India) |
05/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Drug-Drug Interactions(DDI) are common in emergency medicine department as patients are more likely to receive multiple medications simultaneously. In critically ill patients multiple drugs favour the occurrence of DDI with its incidence ranging from 3-30%. DDIs can range from being insignificant to potentially lethal effects. It accounts for 40% of patients visiting emergency department inform of severe adverse drug reactions due to drug interactions. DDIs are associated with significant morbidity, mortality, affect quality of life of patient and can also be primary reason for hospital admission. It can lead to a variety of adverse events, toxic events, loss of efficacy of co-administered drugs. Thus, recognizing and preventing the DDI is important to avoid the adverse outcomes and enhance patient safety. In spite of DDI commonly observed in Emergency Department, the data on monitoring and evaluation of DDI is sparse. Hence the present prospective observational study of drug-drug interactions in emergency medicine department in a tertiary care teaching hospital is done to generate some valid and useful data.
|