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
|
|
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
|
|
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 |