| CTRI Number |
CTRI/2024/06/069384 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of fluid overload in septic patients in intensive care unit |
|
Scientific Title of Study
|
Evaluation of fluid overload in Septic patients admitted to intensive care unit with Combined Venous Excess Lung Ultrasound (VExLUS) Score |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Prithvi |
| Designation |
Post Doctoral Fellow Critical Care Medicine Senior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anaesthesiology,OT Complex 6th Floor,AIIMS Patna,Phulwarisharif,Patna
Patna
BIHAR
801507
India |
| Phone |
9642529246 |
| Fax |
|
| Email |
prithvi.phani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anaesthesiology,OT Complex 5th Floor,AIIMS Patna,Phulwarisharif,Patna
Patna
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anaesthesiology,OT Complex 5th Floor,AIIMS Patna,Phulwarisharif,Patna
Patna
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Patna,Phulwari Sharif,Bihar 501507,India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Department of Anaesthesiology,B Block OT Complex,AIIMS Patna,Bihar 801507,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ajeet Kumar |
All India Institute of Medical Sciences Patna |
Department of Anaesthesiology,OT Complex 5th Floor,AIIMS Patna,Phulwarisharif,Patna
Patna
BIHAR |
9312501413
ajeetanaes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of sepsis (consistent with surviving sepsis campaign guidelines 2021 and clinical indication to be admitted in ICU) |
|
| ExclusionCriteria |
| Details |
Patients in hemodialysis program
Patients with previously known conditions that interfere with portal Doppler assessments, namely liver cirrhosis, or severe tricuspid regurgitation with structural heart disease. If any of these conditions are identified during the present episode, the patient would also be excluded.
Age less than 18 years
Patients subjected to withdrawal of care Hemodynamic instability due to active hemorrhage
Acute coronary syndrome
Indication for immediate surgery
Received CPR within 24 hours of enrollment
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of global fluid overload by measuring VExLUS score |
0-12hrs
24-36hrs
48-72hrs
Discharge time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses correlation between VexLUS score and cumulative fluid balance |
0-12hrs
24-36hrs
48-72hrs
Discharge time |
| To asses correlation between VexLUS score and acute kidney injury |
0-12hrs
24-36hrs
48-72hrs
Discharge time |
| To asses correlation between VexLUS score and ICU length stay |
0-12hrs
24-36hrs
48-72hrs
Discharge time |
| To asses correlation between VexLUS score and congestive respiratory failure(not attributed to other causes) |
0-12hrs
24-36hrs
48-72hrs
Discharge time |
| Proportion of the need for diuretic use or Renal Replacement therapy to correct fluid overload |
0-12hrs
24-36hrs
48-72hrs
Discharge time |
| To predict 28 day mortality on VexLUS score |
0-12hrs
24-36hrs
48-72hrs
Discharge time |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
05/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Hemodynamic management in critically ill septic patients has been traditionally focused on maintaining adequate cardiac output and arterial blood pressure by relying on fluid administration along with vasopressor and inotropic support. However, administration of fluid may lead to venous congestion compromising the organ perfusion which can be overlooked as a hemodynamic parameter on clinical assessment, and could be of utmost importance in management. Point of care ultrasound (POCUS) at bedside allows the clinician to assess the status of intravascular volume and rule out portal, intrarenal and pulmonary fluid overload. The correlation of modified lung ultrasound score and extravascular fluid is a well-known parameter for the assessment of the global fluid status of the patient. Adding a lung ultrasound score to VExUS grading is a novel concept. Lung ultrasound evaluates 6 different lung areas,looking at B lines and graded 0,1,2,3. VExUS protocol evaluates the amount of venous congestion in the abdominal organs, specifically by scanning the portal, hepatic, and intra-renal veins. Doppler interrogation of these vessels yields a specific pattern corresponding to a level of venous congestion: normal, mild, or severe. By combining modified lung ultrasound score and VExUS grading, might lead to improvement in the sensitivity of early fluid overload detection. This is a kind of study to evaluate the VExLUS grades in earlier identification of fluid overload in septic patients. |