| CTRI Number |
CTRI/2025/10/096269 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Creation of a method for seeing harmful effect of saline during and after operation |
|
Scientific Title of Study
|
Development of a Novel Fluid Tolerance index in patients undergoing Emergency Laparotomy |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kritikha R |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology, 5th floor, Teaching Block AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
7395864006 |
| Fax |
|
| Email |
kritikha08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Souvik Maitra |
| Designation |
Additional Professor |
| Affiliation |
AIIMS , New Delhi |
| Address |
Department of Anaesthesiology, 5th floor, Teaching Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8146727891 |
| Fax |
|
| Email |
souvikmaitra@live.com |
|
Details of Contact Person
Public Query
|
| Name |
Souvik Maitra |
| Designation |
Additional Professor |
| Affiliation |
AIIMS , New Delhi |
| Address |
Department of Anaesthesiology, 5th floor, Teaching Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8146727891 |
| Fax |
|
| Email |
souvikmaitra@live.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
AIIMS NEW DELHI 110029, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Kritikha R |
All India Institute of Medical Sciences, New Delhi |
Department of Anaesthesiology, pain medicineand critical care, 5th floor, Academic Block, AIIMS New Delhi 110029
New Delhi
DELHI |
7395864006
kritikha08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS 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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Undergoing emergency abdominal Surgery
2)Duration of surgery at least 2 hours
|
|
| ExclusionCriteria |
| Details |
1) Refusal to participate
2) CKD Stage IV or V
3) Pregnancy
4) Moribund patients with expected survival less than 48 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of a composite index of cumulative fluid balance, estimated colloidal oncotic pressure, and markers of inflammation/endothelial damage to predict the major post operative complication( Clavein Dindo Grade IV-V) |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between Fluid tolerance index and hospital mortality |
72 hours |
| Association of fluid tolerance index and hospital stay |
72 hours |
| Association between individual components and post operative clinical outcome |
72 hours |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
28/10/2025 |
| 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
|
N/A |
|
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 Capillary fluid leak is determined by net filtration pressure and integrity of capillary endothelium and glycocalyx, the latter one cannot be quantified
It arises the need of development of a composite index comprising of colloidal oncotic pressure and markers of inflammation which will module the effect of cumulative fluid balance in post-surgical patients |