CTRI Number |
CTRI/2022/08/044946 [Registered on: 25/08/2022] Trial Registered Prospectively |
Last Modified On: |
05/04/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Retrospective |
Study Design |
Single Arm Study |
Public Title of Study
|
An audit of fluid treatment during surgeries in preplanned surgeries |
Scientific Title of Study
|
Retrospective observational trial of intraoperative fluid management practice in elective cancer surgery |
Trial Acronym |
|
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 Hospital, Mumbai |
Address |
Department of Anaesthesiology, Critical Care and Pain, 2nd floor, Main Building, Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai 400012
Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
mshetmahajan@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Madhavi Shetmahajan |
Designation |
Professor |
Affiliation |
Tata Memorial Hospital, Mumbai |
Address |
Department of Anaesthesiology, Critical Care and Pain, 2nd floor, Main Building, Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai 400012
Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
mshetmahajan@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Kshitija Pimpre |
Designation |
Junior resident III |
Affiliation |
Tata Memorial Hospital |
Address |
Department of Anaesthesiology, Critical Care and Pain, 2nd floor, Main Building, Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai 400012
Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
kshitijapimpre01@gmail.com |
|
Source of Monetary or Material Support
|
Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai 400012 |
|
Primary Sponsor
|
Name |
Tata Memorial Hospital |
Address |
Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai 400012 |
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, Department of Anaesthesiology, Critical Care and Pain, 2nd floor , main bldg, Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai 400012 Mumbai MAHARASHTRA |
9819372075
mshetmahajan@hotmail.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: C00-D49||Neoplasms, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
All adult patients undergoing elective cancer surgery |
|
ExclusionCriteria |
Details |
Patients with blood loss more than 1 litre |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Intraoperative IV fluid volume in ml / ideal body weight / hr and type of IV fluids used in different types of surgery. |
12 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Intraoperative complications such as need for vasopressor therapy, need for mechanical ventilation at the end of surgery or side effects of colloids. |
30 days |
2. In hospital complications will include - Anastomotic dehiscence, ICU /RR stay 48 hrs, sepsis, ICU readmission, re surgery or organ dysfunction. Cardiovascular complications will be defined as any haemodynamic abnormality requiring intervention, need for mechanical ventilation, acute kidney injury, Respiratory complications will be defined as need for mechanical ventilation including HFNC or NIV. CNS dysfunction and liver dysfunction will also be noted |
30 days |
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
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)
|
01/09/2022 |
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) |
Closed to Recruitment of Participants |
Publication Details
|
No publications yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Background: Traditionally, intraoperative fluid administration followed a liberal approach in order to counteract starvation deficits and ‘third space’ losses. However, the concept of ‘third space’ has been challenged. Thus routine infusions of large volumes of intravenous fluid intraoperatively can lead to fluid overload leading to tissue oedema. This in turn increases the oxygen transfer distance, thereby increasing the risk of poor surgical-site healing and postoperative complications such as anastomotic leak and a prolonged length of hospital stay (LOS). Restrictive fluid regimens often aim for a low or zero net fluid balance and restrictive protocols often recommend use of vasopressors to maintain blood pressure. However intraoperative hypovolemia and inappropriate use of vasopressors could increase the risk of tissue hypo perfusion leading to organ dysfunction. Recent studies have shown increased risk of acute kidney injury. Cardiac output monitoring with stroke volume optimisation has been commonly used in goal directed therapy studies in recent years. Optimal preoperative fluid administration in cancer surgery is a challenging clinical problem as cancer surgery often involves extensive dissection, lymph node clearance and blood loss. This along with systemic inflammatory response causes significant fluid shifts and complicates fluid management.
Thus in the current scenario though liberal fluid is discouraged, it is still unclear as to how much fluid administration should be considered as standard as different studies have used different fluid administration rates. This retrospective observational study is aimed at understanding our current intraoperative fluid management practice in elective cancer surgery and its effect on the intraoperative and post operative course in terms of major complications. This data will help us understand of fluid management strategies across surgical specialties and focus studies on particular aspect of fluid management.
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