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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  
Status 
Not Applicable 
 
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.

 
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