| CTRI Number |
CTRI/2024/05/067892 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATION STUDY |
| Study Design |
Other |
|
Public Title of Study
|
comparing noninvasive method ( Massimo sensor pulse oximetry) with invasive method (arterial line pulse pressure variation) for assessing the fluid status intraoperatively in chronic kidney disease patient undergoing renal transplantation for goal directed fluid therapy |
|
Scientific Title of Study
|
Correlation of Pleth variability index PVI with pulse pressure variation PPV and Central Venous
Pressure (CVP) for intraoperative Goal Directed Fluid Therapy in patients undergoing Renal
Transplantation – 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 |
R.Vignesh |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology,
Christian Medical College, Vellore.
Department of Anaesthesiology,
Christian Medical College, Vellore,
Tamilnadu.
Vellore
TAMIL NADU
632004
India |
| Phone |
9159486780 |
| Fax |
|
| Email |
drmbbs333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Georgene singh |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology,
Christian Medical College, Vellore.
Department of Anaesthesiology,
Christian Medical College, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9443292504 |
| Fax |
|
| Email |
GEORGENESINGH@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Georgene singh |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology,
Christian Medical College, Vellore.
Department of Anaesthesiology,
Christian Medical College, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9443292504 |
| Fax |
|
| Email |
GEORGENESINGH@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| FLUID RESEARCH GRANT,CHRISTIAN MEDICAL COLLEGE AND HOSPITAL, VELLORE-632004,TAMILNADU,INDIA |
|
|
Primary Sponsor
|
| Name |
Dr R.Vignesh |
| Address |
Dr R.Vignesh Department of anesthesiology, CHRISTIAN MEDICAL COLLEGE, VELLORE 632004 TAMILNADU,INDIA |
| 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 |
| RVIGNESH |
CHRISTIAN MEDICAL COLLEGE |
5TH FLOOR OPERATION ROOM -1 urology Transplant theatre, DEPARTMENT OF ANAESTHESIA ,RANIPET CAMPUS.
Vellore
TAMIL NADU |
9159486780
drmbbs333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLUE RESEARCH AND ETHICS COMMITTEE CHRISTIAN MEDICAL COLLEGE VELLORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) All consenting CKD patients planned for elective renal transplantation between 18 -65 years |
|
| ExclusionCriteria |
| Details |
1 Patients with preoperative arrhythmias in ECG, Cardiac Failure (NYHA class3,4)
2 Deceased donor Renal Transplantation
3 Patients with deformity of the fingers
4 Patients with hemoglobinopathies
5 Patients with peripheral vascular disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between PVI and PPV,PVI and CVP |
4 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between Hb measured Non invasively vs Hb measured from the Arterial
Blood Gas Analysis
Cut off value of PVI which is related to Delayed Graft Function requirement of dialysis
within first 7 days of renal transplantation postop and Time to Urine output of more than 120 seconds after release of clamp intraoperative |
7 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/06/2024 |
| 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="0"
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
|
Chronic kidney disease is an abnormality of kidney structure or function that is present for more than 3 months. CKD may be due to multiple etiology. Best outcome following renal transplantation is mainly based on the intraoperative hemodynamic parameters such Blood pressure, central venous pressure and fluid status. In renal transplant surgery optimal fluid resuscitation is extremely important so as to ensure successful outcomes. It is a standard practice to measure fluid status using static measures of fluid responsiveness such as Central Venous pressure CVP. More recently dynamic measures of fluid responsiveness such as Pulse Pressure Variation PPV and stroke volume variation SVV have also been shown to be reliable indicators of fluid responsiveness and being followed as a standard of care during renal transplantation. Both these measures require placement of invasive lines. Plethysmography Variation Index PVI has been introduced as a non-invasive dynamic measure to assess the fluid status, predict fluid responsiveness, and guide goal-directed fluid Therapy. PVI, a measurement only available with Masimo SET® pulse oximetry, is the first commercially available index that automatically and continuously calculates the respiratory variations in the photoplethysmogram from data collected noninvasively via a pulse oximetry sensor. PVI is a measure of the dynamic changes in the Perfusion Index PI that occur during one or more complete respiratory cycles. PI reflects the amplitude of the pulse oximeter waveform and is calculated as the pulsatile infrared signal AC or variable component indexed against the non-pulsatile infrared signal. The lower the PVI number, the less variability there is in PI over a respiratory cycle. The higher the variability, the more likely the patient will respond to fluid infusion with an increase in cardiac output. This sensor also provides immediate and continuous hemoglobin SpHb measurement by spectrophotometry and helps in non-invasive continuous estimation of Haemoglobin. The primary objectives of this study is to study the correlation between pleth variability index PVI measured noninvasively by using Massimo rainbow pulse co oximetry with pulse pressure variation PPV and central venous pressure CVP for measuring fluid status of patient for intraoperative goal- directed fluid therapy in patients undergoing Renal Transplantation. |