| CTRI Number |
CTRI/2020/02/023608 [Registered on: 26/02/2020] Trial Registered Prospectively |
| Last Modified On: |
23/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Intraoperative mean arterial pressure variability as a risk factor for cardiac surgery associated acute kidney injury |
|
Scientific Title of Study
|
INTRAOPERATIVE MEAN ARTERIAL PRESSURE VARIABILITY AS A RISK FACTOR FOR CARDIAC SURGERY ASSOCIATED ACUTE KIDNEY INJURY (CSA- AKI); A PROSPECTIVE PILOT 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 |
HARSHIT SINGLA |
| Designation |
junior resident |
| Affiliation |
postgraduate institute of medical education and research |
| Address |
anaesthesia office, level 4, nehru hospital, pgimer
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7986101259 |
| Fax |
|
| Email |
Hsingla500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HARSHIT SINGLA |
| Designation |
junior resident |
| Affiliation |
postgraduate institute of medical education and research |
| Address |
anaesthesia office, level 4, nehru hospital, pgimer
CHANDIGARH
160012
India |
| Phone |
7986101259 |
| Fax |
|
| Email |
Hsingla500@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanveer Samra |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Anaesthesia Office, Level 4, Nehru Hospital, Pgimer
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drtanvirsamra@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| ANAESTHESIA OFFICE, 4TH FLOOR, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, 160012 |
|
|
Primary Sponsor
|
| Name |
Harshit Singla |
| Address |
Anaesthesia Office, Level 4, Nehru Hospital , Pgimer |
| Type of Sponsor |
Other [Individual - HARSHIT SINGLA] |
|
|
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 |
| Harshit Singla |
Advanced Cardiac Centre, Pgimer |
Anaesthesia Office, Level 4 , Nehru Hospital, Pgimer
Chandigarh
CHANDIGARH |
7986101259
hsingla500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pgimer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
UNDERGOING OPEN HEART SURGERY |
|
| ExclusionCriteria |
| Details |
age < 18 and > 60 years
failure to come off first bypass
cardiac output < 35%
preexisting chronic kidney disease
previous cardiac surgery
preoperative use of IABP |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO DETERMINE THE ASSOCIATION OF TIME CORRECTED MAP VARIABILITY INDEX WITH CARDIAC SURGERY ASSOCIATED ACUTE KIDNEY INJURY IN PATIENTS UNDERGOING OPEN HEART SURGERY |
TILL DISCHARGE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO INVESTIGATE ASSOCIATION BETWEEN INTROP MAP VARIABILITY AND DURATION OF POST OPERATIVE MECHANICAL VENTILATION ,ICU STAY, VASOACTIVE INOTROPIC SCORE AND PATIENT MORTALITY |
TILL DISCHARGE AND MORTALITY WITHIN 7 DAYS |
|
|
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)
|
01/03/2020 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS WILL BE A PROSPECTIVE OBSERVATIONAL COHORT STUDY AND WILL BE CONDUCTED IN ADVANCED CARDIAC CENTRE , PGIMER. TOTAL OF 100 PATIENTS WILL BE RECRUITED AS A CONVENIENCE SAMPLE. |