| CTRI Number |
CTRI/2025/03/083223 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Trial to study the venous distension measured by ultrasound and its benefits in major abdominal cancer Surgery |
|
Scientific Title of Study
|
TO EVALUATE VENOUS CONGESTION LEVELS MEASURED BY VENOUS EXCESS ULTRASOUND (VExUS) ON OUTCOME IN MAJOR ABDOMINAL ONCOSURGERY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit kakrotia |
| Designation |
Resident |
| Affiliation |
Command hospital central command |
| Address |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE ,COMMAND HOSPITAL CENTRAL COMMAND,LUCKNOW
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
8727899968 |
| Fax |
|
| Email |
amitkakrotia786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Badal Parikh |
| Designation |
Professor |
| Affiliation |
Command hospital central command |
| Address |
Department of Anaesthesia,Command hospital central command,Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
7073088722 |
| Fax |
|
| Email |
drbadalparikh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit kakrotia |
| Designation |
Resident |
| Affiliation |
Command hospital central command |
| Address |
Department of Anaesthesia and critical care,Command hospital central command,Lucknow cantonment
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
8727899968 |
| Fax |
|
| Email |
amitkakrotia786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital central command,Lucknow cantonment,Lucknow,Uttarpradesh ,india. pin - 226002 |
|
|
Primary Sponsor
|
| Name |
Department of Defence |
| Address |
Command hospital central command,Lucknow cantonment,Lucknow ,uttarpradesh,india.pin:226002 |
| 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 |
| Col Badal parikh |
Command Hospital Central Command |
Department of Anaesthesia and Critical care,command Hospital central command,lucknow cantonment.pin-226002
Lucknow
UTTAR PRADESH |
7073088722
drbadalparikh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE COMMAND HOSPITAL CENTRAL COMMAND LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Schedule for major abdominal oncology surgery , non elective icu admission, severe acute kidney injury 2 fold increase in serum creatinine from premorbid baseline or during current hospitalization or urine output less than 6 mL/kg over preceding 12 hours, ASA grade 2to 4, written informed consent |
|
| ExclusionCriteria |
| Details |
Life threatening indication of RRT, RRT before patient recruitment ,use of ECMO ,Hepatic cirrhosis or other condition with portal hypertension,patient refusal,Acute coronary syndrome,indication for immediate surgery,pregnancy,received cpr within 24 hours,haemodynamic instability due to active haemorrhage,patient with known condition that interfere with portal Doppler assessment, |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Higher VEXUS score correlation with increased mortality in patients undergoing major abdominal Onco surgery |
1 to 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Higher VEXUS score correlation with increased morbidity in terms of long ICU days , number of ventilator days ,KIDIGO category for AKI need for renal replacement therapy |
1 to 28 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/04/2025 |
| 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="0"
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
|
This study is intended the find any benifits of using ultrasound to access venous congestion levels measured by venous excess ultrasound(VEXUS) is patients planned for major abdominal oncosurgeries. The study takes into account the higher vexus score and any association with 28 days higher mortality score.Also the study is intended to study intends to find any relation with higher vexus score and post op morbidity of the patient,in terms of more icu days postop,AKI,ventillator days post op,need of CRT etc. |