FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/08/015337 [Registered on: 14/08/2018] Trial Registered Prospectively
Last Modified On: 13/08/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Pilot study on fluid therapy during surgery in children and its effect on blood sugar and ketones.  
Scientific Title of Study   A Prospective pilot study on perioperative fluid therapy in pediatric patients and its relationship with glucose homeostasis and ketosis.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
3089  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayana Amin 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  drnayana.amin@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Pinjari 
Designation  Post graduate student 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  urmysilence@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nayana Amin 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  drnayana.amin@yahoo.in  
 
Source of Monetary or Material Support  
Tata memorial centre. Dr Ernest Borges Marg, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital,Dr E Borges Marg Parel 
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 Nayana Amin  Tata Memorial Hospital (TMH)  Department of Anaesthesia, Critical Care and Pain, 2 nd floor, Main building, Parel, Mumbai.
Mumbai
MAHARASHTRA 
9820742327

drnayana.amin@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  6.00 Year(s)
Gender  Both 
Details  All infants and children up to 6 years of age, posted for elective major surgeries in TATA memorial hospital [TMH] and Advanced Centre for Treatment, Research and Education in Cancer (ACTREC). 
 
ExclusionCriteria 
Details  .Infants and Children with underlying endocrine or metabolic disorders.
2.Infants and children who are on steroid therapy.
3.Neonates
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe the current practices of perioperative fluid therapy at a tertiary care center,
(TMH and ACTREC) and to assess its adequacy in maintaining plasma glucose and lipid homeostasis without mobilization of the body’s carbohydrate and lipid reserves.  
1. Immediately after induction of anaesthesia
2. Just before extubation
3. 2 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the relationship between the preoperative blood glucose concentrations in the patients and their duration of starvation.
2. To see if there is any correlation between arterial and capillary blood sugar and blood ketone levels 
1. Immediately after induction of anaesthesia
2. Just before extubation
3. 2 hours after surgery 
 
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   N/A 
Date of First Enrollment (India)   20/08/2018 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Perioperative fluid management in paediatric surgical patients has been the focus for considerable interest and debate. The practice of using glucose containing hypotonic maintenance crystalloid solutions for perioperative fluid therapy is being questioned as there have been many case reports of serious morbidity or even death in previously healthy children associated with the administration of i.v. fluids and hospital-acquired hyponatraemia. Recent studies have shown that hypotonic solutions along with stress induced increased secretion of antidiuretic hormone (ADH) perioperatively can lead to hyponatraemic encephalopathy, permanent neurological damage and even death in children. Over the years there is increasing evidence that blood sugars remain high despite using glucose free solutions. The blood sugars may be normal due to endocrine or metabolic stress, so whether or not to use glucose containing fluids intraoperatively remains a controversy. Association of Paediatric Anaesthetists of Great Britain and Ireland consensus guidelines and European consensus statement guidelines recommend intraoperative use of low dextrose (1–2.5%)containing isotonic fluids which have been shown to maintain acceptable blood glucose levels and prevent electrolyte imbalances during surgery. It is not known whether such low glucose-containing fluids maintain blood glucose levels by initiating catabolism of the body’s own stores. The extent to which such a response can be limited by supplying additional glucose without causing undue hyperglycaemia needs evaluation. If adequate carbohydrates are not provided to fasting children it may lead to ketosis.  This study aims to observe relation between perioperative fluid therapy and its effects on glucose and lipid homeostasis.

 
Close