| CTRI Number |
CTRI/2024/05/067139 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to understand the use of drugs which raise the blood pressure during cancer surgery |
|
Scientific Title of Study
|
Prospective observational trial of intraoperative use of vasopressor and inotropic drug infusion in elective cancer surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhavi Shetmahajan |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre, Mumbai |
| Address |
Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Centre, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9819372075 |
| Fax |
|
| Email |
mshetmahajan@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Madhavi Shetmahajan |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre, Mumbai |
| Address |
Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Centre, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9819372075 |
| Fax |
|
| Email |
mshetmahajan@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prachi Rathod |
| Designation |
Junior Registrar III |
| Affiliation |
Tata Memorial Centre, Mumbai |
| Address |
Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Centre, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
7499863339 |
| Fax |
|
| Email |
prachirathod987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, E Borges Marg, Parel, Mumbai 400012, India |
|
|
Primary Sponsor
|
| Name |
Tata memorial Centre Mumbai |
| Address |
E Borges Marg, Parel, mumbai 400012 India |
| 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 Madhavi Shetmahajan |
Tata memorial Hospital |
operation theatre complex, 2nd floor, main building, Tata Memorial Hospital, E Borges Marg, Parel, Mumbai India Mumbai MAHARASHTRA |
9819372075
mshetmahajan@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients undergoing elective cancer surgery and requiring intraoperative inotrope or vasopressor drug infusions will be studied |
|
| ExclusionCriteria |
| Details |
Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of adult patients undergoing elective cancer surgery requiring intraoperative vasopressor / inotrope infusions |
At completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the indication for starting vasopressor therapy
2. To study the choice of vasoactive agent, the average dose and duration of the agent
3. To understand the preoperative factors in patients requiring vasopressor / inotrope infusions e.g.comorbid conditions
4. To study the intraoperative factors e.g.type and duration of surgery, intraoperative fluid management strategy, blood loss, urine output, route of administration of vasopressorsetc
5. To study the postoperative factors such as need for and duration of postoperative fluid therapy, postoperative morbidity and mortality.
|
Data will be collected
1. During surgery
2. At discharge from recovery room
At discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
22/05/2024 |
| 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)
Modification(s)
|
Not Applicable |
| 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
|
Background:Intraoperative hypotension is common in
major oncological surgeries due to factors like hypovolemia, decreased systemic
vascular resistance (SVR), and decreased inotropicity. Considering the
complications associated with excessive fluid administration ,fluid management
strategies have shifted towards conservative fluid therapy . This approach
often necessitates the use of vasopressors and/or inotropes to maintain normal
blood pressure. A rise in renal injury with restrictive fluid management is
highlighted by many recent studies. Balanced fluid therapy, aiming for specific
hemodynamic targets, has led to increased use of vasopressors. This study aims
to understand the current patterns of intraoperative vasopressor and inotrope
usage in elective cancer surgeries and determine the complications in these patients. Study Methodology:All adult patients undergoing
elective cancer surgery requiring intraoperative vasopressor or inotrope
infusions will be enrolled in this prospective observational trial. Decision regarding vasopressor use will be made by attending anesthesiologists. Data will
be collected prospectively from electronic and physical medical records. Revised Cardiac Risk Index will be calculated in all cases. Data collection will include demographic details,
comorbidities, intraoperative variables, and postoperative outcomes. We will use the 5 point Major Adverse Cardiovascular Events (MACE )
criteria to determine postoperative cardiovascular complications. Statistical Data Analysis
Descriptive Analysis descriptive
statistics will be used to summarize the characteristics of the study
population, including age, gender, comorbidities, type of cancer surgery, and
the incidence of vasopressor/inotrope use. Continuous variables will be
described using means and standard deviations, while categorical variables will
be described using frequencies and percentages.
|