| CTRI Number |
CTRI/2024/03/063446 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
The use of pulse-oximeter derived parameter to determine the need of intravenous fluid supplementation immediately after cardiac surgery in the ICU |
|
Scientific Title of Study
|
Ability of plethysmographic perfusion index to detect fluid responsiveness during the immediate post-operative period in cardiothoracic surgery patients – 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 |
Dr Abinaya Prakashbabu U |
| Designation |
Senior resident |
| Affiliation |
Sree Chitra Thirunal Institute of Medical Sciences and Technology |
| Address |
Department of Cardiothoracic and Vascular Anesthesia,
SCTIMST
Thiruvananthapuram
Thiruvananthapuram KERALA 695011 India |
| Phone |
8608289662 |
| Fax |
|
| Email |
abinayaup@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Subin Sukesan |
| Designation |
Professor |
| Affiliation |
Sree Chitra Thirunal Institute of Medical Sciences and Technology |
| Address |
Department of Cardiothoracic and Vascular Anesthesia,
SCTIMST
Thiruvananthapuram
Thiruvananthapuram KERALA 695011 India |
| Phone |
|
| Fax |
|
| Email |
subin@sctimst.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Abinaya Prakashbabu U |
| Designation |
Senior resident |
| Affiliation |
Sree Chitra Thirunal Institute of Medical Sciences and Technology |
| Address |
Department of Cardiothoracic and Vascular Anesthesia,
SCTIMST
Thiruvananthapuram
Thiruvananthapuram KERALA 695011 India |
| Phone |
8608289662 |
| Fax |
|
| Email |
abinayaup@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Chitra Thirunal Institute of Medical Sciences and technology |
|
|
Primary Sponsor
|
| Name |
Sree Chitra Thirunal Institute Medical Sciences and Technology |
| Address |
Department of Cardiothoracic and Vascular anesthesia,
SCTIMST,
Thiruvananthapuram |
| 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 |
| Dr Abinaya Prakashbabu U |
Sree Chitra Thirunal Institute of Medical Sciences and Technology |
Division of Cardiothoracic & Vascular Anesthesia, Department of Anesthesia, SCTIMST,
Thiruvananthapuram Thiruvananthapuram KERALA |
8608289662
abinayaup@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I059||Rheumatic mitral valve disease, unspecified, (2) ICD-10 Condition: I069||Rheumatic aortic valve disease, unspecified, (3) ICD-10 Condition: I079||Rheumatic tricuspid valve disease,unspecified, (4) ICD-10 Condition: I089||Rheumatic multiple valve disease,unspecified, (5) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (6) ICD-10 Condition: I349||Nonrheumatic mitral valve disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil, as it is an observational study |
| Comparator Agent |
Nil |
Nil, as it is an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All postoperative adult patients scheduled for elective cardiothoracic surgery |
|
| ExclusionCriteria |
| Details |
Refusal to participate
Emergency surgeries
Redo surgery
Severe LV dysfunction
Preoperative inotropic requirement
Arrythmias
Vasoactive-inotrope score of more than 15
Massive blood loss
Patients on renal replacement therapy |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To study the reliability of change in plethysmographic perfusion index for predicting fluid responsiveness immediately following admission in adult postoperative ICU after cardiothoracic surgery till peripheral temperature is increased |
0 min, 15 min, 30 min, 60 min, 120 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare change in plethysmographic perfusion index with parameters involving change in VTI, CVP, IVC diameter for detecting fluid responsiveness.
In fluid responders, whether any change in PPI can predict the fluid requirement |
0 min, 15 min, 30 min, 60 min, 120 min |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
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)
|
10/03/2024 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Hemodynamic management post-cardiac surgery is crucial for optimal patient outcomes. Hemodynamic instability is common, exacerbated by hypovolemia and vasodilation. The goal is to maintain perfusion and oxygen delivery, targeting variables like heart rate, mean arterial pressure, and central venous pressure. Fluid resuscitation is vital for early instability, addressing blood loss, vascular capacitance, fluid losses, and increased preload requirements. Assessing preload dynamics is challenging, with static pressures poorly predicting fluid responsiveness. Dynamic approaches like pulse pressure and stroke volume variation have limitations.
Plethysmographic perfusion index (PI) offers a non-invasive method to assess fluid responsiveness. PI, derived from pulsatile and non-pulsatile light absorption, reflects arterial volume changes during the cardiac cycle. PI varies with changes in vascular tone, making it a potential indicator of fluid responsiveness. Studies show correlations with vascular tone changes induced by anesthesia and vasopressors.
Our study aims to validate PI for detecting fluid responsiveness in postoperative cardiac patients during warming until peripheral temperature reaches 30 C. We’ll also explore the correlation between PI changes and fluid requirements. If proven reliable, PI could revolutionize non-invasive fluid assessment, aiding cardiac care providers in optimal postoperative fluid resuscitation.
Hypothesis:
There is correlation between change in plethysmographic perfusion index and postoperative fluid responsiveness in immediate postoperative period in patients who underwent cardiothoracic surgery. |