| CTRI Number |
CTRI/2024/10/076066 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of total fluid balance in patients with mechanical ventilator support admitted to Intensive Care Unit |
|
Scientific Title of Study
|
Association between cumulative balance and extubation failure in multi-disciplinary intensive care unit, a prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Blessy |
| Designation |
Post Graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai.
Chennai TAMIL NADU 600116 India |
| Phone |
7397647382 |
| Fax |
|
| Email |
blsy2721@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Velumuragn selvam |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai.
Chennai TAMIL NADU 600116 India |
| Phone |
9968859560 |
| Fax |
|
| Email |
dr.velsri86@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr MK Renuka |
| Designation |
Professor and Head Of Department |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai.
Chennai 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
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 |
| 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 |
| Blessy |
Sri Ramachandra Institute Of Higher Education and Research |
Department of Critical Care Medicine, Sri Ramachandra Institute Of Higher Education and Research, Porur, Chennai Chennai TAMIL NADU |
7397647382
blsy2721@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of age
Patients receiving invasive ventilation more than 24 hours
After successful completion of SBT
|
|
| ExclusionCriteria |
| Details |
Patients below 18 years of age
Patients who are already extubated
Mechanically ventilated for less than 24 hours
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the impact of cumulative fluid balance in relation to extubation. |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze the baseline parameters associated with extubation. |
Six months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
02/12/2024 |
| 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
|
A
positive cumulative fluid balance is known to be associated with increased
mortality in critically ill patients. Studies have shown favorable clinical
outcomes by achieving negative fluid balance in the later stage of critical
illness. There is a strong biological plausibility to believe that the
cumulative fluid balance will have its impact on the respiratory outcome of
patients. A positive cumulative fluid balance leads to increased capillary
leak, increase in extravascular lung water, and decrease in lung compliance and
may result in respiratory failure both during spontaneous breathing trial (SBT)
and in the immediate post extubation period. Restrictive fluid strategy has
shown to decrease the length of mechanical ventilation, intensive care unit
(ICU) length of stay, and a trend toward decreased mortality in patients with
acute respiratory distress syndrome. In an earlier study, the relationship
between fluid balance and weaning outcome was explored. Both negative fluid
balance 24‑h
pre-extubation and negative net cumulative balance since intubation were found
to be independently associated with successful weaning. However, extensive use
of diuretics in the study population and majority of patients achieving
negative fluid balance or euvolemia at the first SBT questions the
generalizability of the study results. |