| CTRI Number |
CTRI/2024/06/069613 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Hemodynamic Variations In Intensive Care Unit Patients During Dialysis |
|
Scientific Title of Study
|
An Observational Prospective Study On Hemodynamic Instability During Ongoing Dialysis In ICU Patients. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K.Deepak Vamsi |
| Designation |
Post Graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Criticalcare Medicine, M.sc Criticalcare Technology,
Sri Ramachandra Institute of Higher Education and Research, Chennai-116, Tamil Nadu, India
Department of Criticalcare
Medicine, M.sc Criticalcare Technology, Sri Ramachandra Institute of Higher Education and Research, Chennai-116, Tamilnadu, India
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
6304440841 |
| Fax |
|
| Email |
deepakvamsikaichetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMKRenuka |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Criticalcare Medicine, Head of Department
G block 1st Floor, Sri Ramachandra Institute of Higher Education and Research, Chennai-116
Department of Criticalcare Medicine, Head of Department
G block 1st floor Sri Ramachandra Institute of Higher Education and Research, Chennai-116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrMKRenuka |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research, Chennai 116 |
| Address |
Department of Criticalcare Medicine,G block, 1st Floor Sri Ramachandra Institute of Higher Education and Research, Chennai-116.
Department of Criticalcare Medicine,G block 1st Floor,Sri Ramachandra Institute of Higher Education and Research, Chennai 116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur,Chennai-116 |
|
|
Primary Sponsor
|
| Name |
sri ramachandra institute of higher education and research |
| Address |
Sri Ramachandra Institute of Higher Education and Research Porur Chennai - 116 |
| 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 |
| KDEEPAKVAMSI |
sri ramachandra institute of higher education and research |
Department of criticalcare medicine sri ramachandra institute of higher education and research porur chennai - 116
Thiruvallur
TAMIL NADU |
6304440841
deepakvamsikaichetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri ramachandra institute of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N19||Unspecified kidney failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients With changes in hemodynamic status (B.P., PULSE RATE)30% from baseline of the during dialysis procedure |
|
| ExclusionCriteria |
| Details |
Patients Recievied Into Intensive Care unit with Ongoing Inotropic/Vasopressor Supports From Emergency/Ward |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the disease/pathological condition leading to the highest incidence of hemodynamic instability in Intensive care patients during ongoing dialysis |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
NIL |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
15/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In this study The Diagnosis that has the highest incidence of hemodynamic Instability during on going
dialysis in intensive care unit patients, by monitoring the patient’s vitals, scoring during the
dialysis process |