| CTRI Number |
CTRI/2024/10/075576 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Two Scores to Assess Fluid Overload in Adult Patients in ICU |
|
Scientific Title of Study
|
Evaluation of Combined Venous Excess Grading System And Lung Ultrasound Score To Assess Organ Congestion In Adult Patients in Sepsis |
| 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 Safiya Sherrin M K |
| Designation |
Senior Resident |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Senior Resident, Department of Critical Care Medicine, Dayanand Medical College and Hospital, Ludhiana, PIN-141001, Punjab, India Oasis, Viswas Kattachira Road, P.O. BP Angadi, Tirur, Malappuram District, Kerala, PIN-676102, India Ludhiana PUNJAB 141001 India |
| Phone |
9496809481 |
| Fax |
|
| Email |
safiyasherrin01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gunchan Paul |
| Designation |
Professor |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of Critical Care Medicine, Dayanand Medical College and Hospital, Ludhiana, PIN-141001, Punjab, India
Ludhiana PUNJAB 141001 India |
| Phone |
9878645330 |
| Fax |
|
| Email |
gunchan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Safiya Sherrin M K |
| Designation |
Senior Resident |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Senior Resident, Department of Critical Care Medicine, Dayanand Medical College and Hospital, Ludhiana, PIN-141001, Punjab, India Oasis, Viswas Kattachira Road, P.O. BP Angadi, Tirur, Malappuram District, Kerala, PIN-676102, India Ludhiana PUNJAB 141001 India |
| Phone |
9496809481 |
| Fax |
|
| Email |
safiyasherrin01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Critical Care Medicine, Dayanand Medical College and Hospital, Civil Lines, Tagore Nagar, Ludhiana, Punjab, PIN-141001 |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College & Hospital |
| Address |
Civil Lines, Tagore Nagar, Ludhiana, Punjab 141001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Safiya Sherrin M K |
Dayanand Medical College & Hospital |
Department of Critical Care Medicine, Civil Lines, Tagore Nagar, Ludhiana - 141001 Ludhiana PUNJAB |
9496809481
safiyasherrin01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research & Ethics Committee, Dayanand Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with septic shock requiring Intensive Care Unit admission.
2.Sepsis and septic shock criteria met as per surviving sepsis campaign guidelines 2021
|
|
| ExclusionCriteria |
| Details |
1.No consent to participate in study
2.Indication for ICU admission other than sepsis
3.Patients with previously known conditions that interfere with portal Doppler assessments, namely liver cirrhosis, or severe tricuspid regurgitation or structural heart disease.
4.Age is lesser than 18 years
5.Preexisting conditions like pregnancy, acute coronary syndrome, hemodynamic instability, post cardiopulmonary resuscitation in the last 24 hours
6.Patients needing surgeries, on haemodialysis
7.Patients subjected to withdrawal of care.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate whether a combined modified lung ultrasound score (LUS)and Venous Excess Ultrasound (VExUS) protocol called VExLUS score in adult patients with sepsis can improve sensitivity and early identification of fluid overload. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To correlate VExLUS score with signs of intensive fluid administration
2.To correlate VExLUS score with duration of mechanical ventilation, length of ICU-stay and 28-day mortality |
28 days |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
15/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Introduction: Sepsis and septic shock are one of the most common indications for intensive care unit admission. Fluid resuscitation is one of the cornerstones in management of such patients. However, overzealous fluid therapy leads to congestion and poor perfusion. Point of care ultrasound can be used for venous excess ultrasound and combined with lung ultrasound to look for fluid overload state and to guide fluid therapy. Aim of Study: To assess utility of combined lung ultrasound and venous excess grading system in early identification of fluid overload state and organ congestion Materials& methods: Patient admitted with septic shock in our intensive care unit will be assessed for fluid overload using point of care ultrasound focusing on lung ultrasound (LUS) and Venous Excess Ultrasound (VExUS) scores. Combined VExLUS score will be ascertained along with various biochemical parameters and its outcome will be measured in terms of early diagnosis of fluid overload and end organ damage. Clinical Significance: Combined lung ultrasound and Venous Excess Ultrasound grading can be used to identify fluid overload and tissue congestion at an early stage including identification of end organ damage due to congestion leading to poor perfusion for better clinical outcome and prognosis of patient. |