| CTRI Number |
CTRI/2024/06/069249 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the effect of compressing upper arm with a blood pressure cuff to produce ischemia and its effect in reducing myocardial injury during hemodialysis in study participants. |
|
Scientific Title of Study
|
Role of remote ischemia preconditioning in reducing myocardial injury in chronic kidney disease patients on maintenance hemodialysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasoon Sebastian |
| Designation |
Senior Resident |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE KOZHIKKODE |
| Address |
Department of Nephrology
Government medical college, Kozhikode, Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9497320626 |
| Fax |
|
| Email |
prasoon992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreelatha M |
| Designation |
Head of Department |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE KOZHIKKODE |
| Address |
Department of Nephrology
Government medical college, Kozhikode, Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9497320626 |
| Fax |
|
| Email |
nephcal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prasoon Sebastian |
| Designation |
Senior Resident |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE KOZHIKKODE |
| Address |
Department of Nephrology
Government medical college, Kozhikode, Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9497320626 |
| Fax |
|
| Email |
prasoon992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college Kozhikode, Kerala, India,673008 |
|
|
Primary Sponsor
|
| Name |
Prasoon Sebastian |
| Address |
Senior Resident
Department of Nephrology
Government medical college, Kozhikode, Kerala, India 673008 |
| Type of Sponsor |
Other [self] |
|
|
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 Prasoon Sebastian |
Government medical college, Kozhikode |
Room number 402
Department of Nephrology,
Super speciality block.
Government medical college
Kozhikode,
Kerala, India, 673008
Kozhikode
KERALA |
9497320626
prasoon992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
remote ischemia preconditioning |
Before each HD session, a standard blood pressure cuff will be placed around the arm that did not have vascular access, usually the right arm. In the control group, the cuff is inflated to 50-mmHg pressure for 5 min, followed by 5 min of deflation to allow reperfusion. This procedure is repeated three times during a hemodialysis session. it will be done for 12 consecutive emodialysis session thus lasting study for a period of one month |
| Intervention |
Remote ischemia preconditioning |
Before each HD session, a standard blood pressure cuff will be placed around the arm that did not have vascular access, usually the right arm. In the intervention group, the cuff is inflated to 200-mm Hg pressure for 5 min, followed by 5 min of deflation to allow reperfusion. This procedure is repeated three times during the initial period of hemodialysis lasting 30 minutes. it will be done for 12 consecutive hemodialysis session,thus having a stidy duration of 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
CKD stage 5 patients on maintenance hemodialysis
Age between 18 to 65
|
|
| ExclusionCriteria |
| Details |
Patients who had acute coronary syndrome, stable angina pectoris, or decompensated heart failure in the 6 months before inclusion
Overt cardiac failure: NYHA CLASS 3 and CLASS 4
Patients with cerebrovascular disease, chronic liver disease, gastrointestinal bleed, malignancy
Current smoker
Patients with cardiac event during study period
Patients developing intradialytic hypotension requiring inotropic support
Patients not willing to participate in study
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in cardiac injury during dialysis assessed using trop I levels |
At 3rd, 7th day and at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
01/07/2024 |
| 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="2"
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
|
Chronic kidney disease patients on maintance hemodialysis are at increased risk of cardiovascular disease. Mortality occurs in these patients due to cardiovascular diseases. Even during hemodialysis, these patients are prone to myocardial injury which can affect their cardiac health. all measures which can reduce the myocardial injury in these group of patients have to be sought. remote ischemia preconditioning, which is easy to perform, is considered to be one such measure. this study aims to look for the benefit of remote ischemia preconditioning intervention in reducing myocardial injury in hemodialysis patients. |