FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063491 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 02/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   In patients who undergo abdominal surgeries in emergency, does the ratio of fluid balance to oncotic pressure in blood vessels correlate with surgical outcomes? 
Scientific Title of Study   Association between cumulative fluid balance to estimated colloid oncotic pressure ratio and perioperative outcome in adult patients undergoing emergency abdominal surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arushi 
Designation  Junior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care 5th floor, Academic Block All India Institute of Medical Sciences, New Delhi PIN 110029

New Delhi
DELHI
110029
India 
Phone  9205678052  
Fax    
Email  mailtoarushi511@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Souvik Maitra 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care 5th floor, Academic Block All India Institute of Medical Sciences, New Delhi PIN 110029

New Delhi
DELHI
110029
India 
Phone  8146727891  
Fax    
Email  souvikmaitra@live.com  
 
Details of Contact Person
Public Query
 
Name  Arushi 
Designation  Junior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care 5th floor, Academic Block All India Institute of Medical Sciences, New Delhi PIN 110029

New Delhi
DELHI
110029
India 
Phone  9205678052  
Fax    
Email  mailtoarushi511@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi- 110029 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [(NIL)] 
 
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 Arushi  All India Institute of Medical Sciences, New Delhi  Address 1: D6 (GI Surgery) ICU, 6th floor, Ward Block, Main Building, All India Institute of Medical Sciences, New Delhi - 110029 Address 2: Surgical ICU, 6th floor, New Surgical Block, All India Institute of Medical Sciences, New Delhi - 110029
New Delhi
DELHI 
9205678052

mailtoarushi511@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  75.00 Year(s)
Gender  Both 
Details  Adult patients (aged 18-75 years)
Either sex
Undergoing emergency abdominal surgery
Duration of surgery at least 2 hours
 
 
ExclusionCriteria 
Details  Refusal to participate
CKD stage IV or V
AKI stage III or more at the time of admission
Pregnancy
Moribund patients with expected survival <48 hours
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association between cumulative fluid balance to estimated colloid oncotic pressure ratio at 48 hours and any grade of Clavien-Dindo complication after emergency abdominal surgery  30 days postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Association between cumulative fluid balance to estimated colloid oncotic pressure ratio at 48 hours and Clavien-Dindo grade IVa/b and V complication  30 days postoperatively 
Association between perioperative fluid balance to estimated colloid oncotic pressure ratio (hospital admission to end of surgery) and postoperative complications  30 days postoperatively 
Association between cumulative fluid balance/estimated colloid oncotic pressure ratio at 48 hours and hospital free days at day 30  30 days postoperatively 
Association between cumulative fluid balance/estimated colloid oncotic pressure ratio at 48 hours and 30-day mortality  30 days postoperatively 
Association between cumulative fluid balance/estimated colloid oncotic pressure ratio at 48 hours and postoperative AKI within postoperative day 7  7 days postoperatively 
 
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)   14/03/2024 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Fluid therapy is the cornerstone of patient management in the perioperative setting. While a liberal approach to fluid therapy was used in the past to prevent hypovolemia and improve organ perfusion, it was shown that tissue inflammation and consequent extravascular leak led to fluid accumulation in the third space, contributing to perioperative complications. As evidence emerged that a positive fluid balance was associated with increased risk of adverse surgical outcomes as well as organ dysfunction, such as acute lung injury, acute kidney injury and prolonged duration of mechanical ventilation and ICU stay, restricted or goal-directed fluid therapy (zero-balance approach) began to replace the conventional approach to fluid management.

Whenever intravenous fluid therapy is administered for any reason, only a portion of the total fluid received stays inside the intravascular compartment; the rest extravasates into the capillary interstitial space. Adverse effects of intravenous fluid therapy often relate to this extravasation of intravascular fluid, as it causes tissue edema and decreased tissue oxygen delivery leading to poor clinical outcome. One of the four major Starling forces, the plasma colloid oncotic pressure determines the intravascular stay of fluid. Inflammation causes endothelial damage leading to leaky capillaries that exude fluid and protein, reducing the oncotic pressure. Albumin being a negative acute phase reactant is reduced in the perioperative setting and contributes to a lowered value of colloid oncotic pressure.

We postulate that this decreased plasma oncotic pressure might contribute to enhanced extravascular leak that leads to poorer outcomes. While a number of studies have shown adverse clinical outcomes associated with a positive fluid balance intra- and post-operatively, the effect of a reduced colloid oncotic pressure has not been studied in the perioperative period for non-cardiac surgeries.  Furthermore, no study has attempted to see if the ratio of positive cumulative fluid balance to colloid oncotic pressure can be a useful predictor for post-operative complications.

Study hypothesis: Higher cumulative fluid balance to estimated colloid oncotic pressure ratio will be associated with poorer outcomes in patients undergoing emergency abdominal surgery

 
Close