| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
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. |