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CTRI Number  CTRI/2024/07/070389 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 05/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Diaphragmatic assessment using ultrasound to take children off ventilator following liver transplantation 
Scientific Title of Study   Diaphragmatic function assessment by ultrasonography in paediatric LDLT Recipients 
Trial Acronym  DIAS Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Susan Paulin 
Designation  Associate Consultant 
Affiliation  Dr. Rela Institute & Medical center 
Address  Department of Liver transplant anaesthesia and critical care, 3 rd floor ICU office, Dr Rela institute and medical centre, Chrompet, Chennai
Shankar nagar, Chrompet, Chennai-44
Kancheepuram
TAMIL NADU
600044
India 
Phone  919994519890  
Fax    
Email  susanvercetti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Susan Paulin 
Designation  Associate Consultant 
Affiliation  Dr. Rela Institute & Medical center 
Address  Department of Liver transplant anaesthesia and critical care, 3 rd floor ICU office, Dr Rela institute and medical centre, Chrompet, Chennai
Shankar nagar, Chrompet, Chennai-44

TAMIL NADU
600044
India 
Phone  919994519890  
Fax    
Email  susanvercetti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Susan Paulin 
Designation  Associate Consultant 
Affiliation  Dr. Rela Institute & Medical center 
Address  Department of Liver transplant anaesthesia and critical care, 3 rd floor ICU office, Dr Rela institute and medical centre, Chrompet, Chennai
Shankar nagar, Chrompet, Chennai-44

TAMIL NADU
600044
India 
Phone  919994519890  
Fax    
Email  susanvercetti@gmail.com  
 
Source of Monetary or Material Support  
Dr. Rela Institute and medical centre, Department of Liver transplant anaesthesia and critical care, 3 rd floor ICU office, Chrompet, Chennai-44 
 
Primary Sponsor  
Name  Dr. Rela Institute and medical center 
Address  Shankar Nagar, Chrompet, Chennai-44 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akila Rajakumar  Dr. Rela Institute and medical center  Department of Liver transplant anaesthesia and critical care, 3 rd floor ICU office, Dr Rela institute and medical centre, Chrompet, Chennai
Kancheepuram
TAMIL NADU 		 04466667777

drakila.rajakumar@gmail.com 
Dr Susan Paulin  Dr. Rela Institute and medical center  Department of Liver transplant anaesthesia and critical care, 3 rd floor ICU office, Dr Rela institute and medical centre, Chrompet, Chennai
Kancheepuram
TAMIL NADU 		 919994519890

susanvercetti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC- Dr. Rela Institute and medical centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All pediatric LDLT recipients aged 18 years and below 
 
ExclusionCriteria 
Details  Patients with known history of diaphragmatic palsy, Intraoperative diaphragmatic injury, patients with prolonged ventilation for moe than 7 days prior to transplant. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate the utility of diaphragmatic function assessment by ultrasonography in the weaning process of children following liver transplantation  WEEK 1 
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate the factors that contribute to delayed weaning in children following LT  week 1, week 2 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="55" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/07/2024 
Date of Study Completion (India) 31/01/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [susanvercetti@gmail.com].

  6. For how long will this data be available start date provided 15-07-2024 and end date provided 31-12-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

All pediatric LDLT recipients will undergo DIaphragmatic function Assessment by ultraSonography on POD 1,2,3 and then once every week until successful extubation. Data regarding general demographics, anthropometry, preoperative factors, intraoperative details such blood loss, duration of surgery, fluid, blood and products administration, graft details, closure details, postoperative details such as fluid balance, vasopressor requirements, sepsis, ventilatory parameters, nutritional status and weaning attempts will be collected.

 

 
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