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CTRI Number  CTRI/2020/02/023561 [Registered on: 25/02/2020] Trial Registered Prospectively
Last Modified On: 23/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intraoperative liberal versus goal directed fluid therapy in neonates 
Scientific Title of Study   Intraoperative liberal versus goal directed fluid therapy in neonates - A prospective randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swathy A S 
Designation  Junior Resident 
Affiliation  PGIMER 
Address  Department of anaesthesia and intensive care, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8448750607  
Fax    
Email  swathyas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neerja Bhardwaj 
Designation  Professor 
Affiliation  PGIMER 
Address  Department of anaesthesia and intensive care, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  neerja.bhardwaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swathy A S 
Designation  Junior Resident 
Affiliation  PGIMER 
Address  Department of anaesthesia and intensive care, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8448750607  
Fax    
Email  swathyas@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia and intensive care, PGIMER, Chandigarh  
 
Primary Sponsor  
Name  Department of anaesthesia and intensive care 
Address  PGIMER, Chandigarh, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swathy A S  PGIMER  Operation room, Level 6, Advanced pediatric center
Chandigarh
CHANDIGARH 		 8448750607

swathyas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P788||Other specified perinatal digestive system disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Goal directed fluid therapy  Pleth variability index will be used to assess fluid responsiveness intra-operatively to guide fluid administration 
Comparator Agent  Liberal fluid therapy  Intra-operative fluid will be administered based on Holliday-segar formula 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Term neonates undergoing emergency abdominal surgeries  
 
ExclusionCriteria 
Details  CDH, TEF, Neonates with congenital heart disease, hemodynamically unstable neonates on inotropes, neonates with heart failure or respiratory disorders, creatinine clearance less than 90ml/min 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of the total amount of fluid infused intra-operatively in both the groups  At the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative lactate, pH, HCO3, base excess and sodium levels   At the beginning and end of surgery 
Intraoperative urine output  At the end of surgery 
Intraoperative use of dopamine   At the end of surgery 
Postoperative complications pertaining to tissue perfusion (anastomotic leak, delayed wound healing)  At the time of discharge 
Postoperative recovery of bowel function (flatus time/ return of bowel sounds)  At the time of discharge 
Serum electrolytes, Blood urea and Serum creatinine levels   Before and after surgery 
Postoperative duration of hospital stay  At the time of discharge 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   26/02/2020 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRAOPERATIVE LIBERAL VERSUS GOAL DIRECTED FLUID THERAPY IN NEONATES - A PROSPECTIVE RANDOMISED CONTROLLED TRIAL : This study will be conducted in PGIMER, Chandigarh in the Department of Anaesthesia and Intensive care by Dr.Swathy.A.S as part of her post-graduate thesis. The study will compare two different intra-operative fluid regimens in term neonates undergoing emergency abdominal surgeries. In the liberal group, fluid will be administered according to Holliday - Segar formula whereas in the goal directed group, fluid will be administered after assessing the fluid responsiveness of the patient by Pleth variability Index. Total amount of fluid administered in the both the groups, various blood parameters that influence the post-operative morbidity, post-operative complications and length of hospital stay will be assessed and compared.


 
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