FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close