| CTRI Number |
CTRI/2018/05/014231 [Registered on: 30/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intravenous maintenance fluids] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Type of injectable fluids and associated electrolyte abnormalities among children |
|
Scientific Title of Study
|
Intravenous fluid regimen and dyselectrolytemia among children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Balaji C |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital & Research Institute |
| Address |
1003, B block, staff medical quarters, SRM University campus, potheri, Kattankulathur 1003, B block, staff medical quarters, SRM University campus, potheri, Kattankulathur Kancheepuram TAMIL NADU 603203 India |
| Phone |
8220239296 |
| Fax |
|
| Email |
balajictriumphants@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Balaji C |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital & Research Institute |
| Address |
Dept. of pediatrics, SRM medical college hospital & research institute, potheri, kattankulathur 1003, B block, staff medical quarters, SRM University campus, potheri, Kattankulathur Kancheepuram TAMIL NADU 603203 India |
| Phone |
8220239296 |
| Fax |
|
| Email |
balajictriumphants@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Balaji C |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital & Research Institute |
| Address |
1003, B block, staff medical quarters, SRM University campus, potheri, Kattankulathur 1003, B block, staff medical quarters, SRM University campus, potheri, Kattankulathur Kancheepuram TAMIL NADU 603203 India |
| Phone |
8220239296 |
| Fax |
|
| Email |
balajictriumphants@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital & Research Institute, Potheri, Kattankulathur, Tamil nadu, 603203 |
|
|
Primary Sponsor
|
| Name |
SRM Medical college Hospital research institute |
| Address |
Potheri, Kattankulathur, Tamilnadu 603203 |
| 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 Balaji Chinnasami |
SRM Medical college hospital and research institute |
Department of pediatrics,Pediatric ward Kancheepuram TAMIL NADU |
8220239296
balajictriumphants@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical college Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children not critically ill admitted for various diseases and expected to receive fluids for 24 hours., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DNS |
Normal maintenance requirement will be the dosage. Intravenous route given continuously during admission period or maximum of 72 hours. |
| Comparator Agent |
Isolyte P |
Normal maintenance requirement will be the dosage. Intravenous route given continuously during admission period or maximum of 72hours |
| Intervention |
Plasma-Lyte 148 |
Normal maintenance requirement will be the dosage. Intravenous route given continuously during admission period or maximum of 72 hours |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children who are judged by the treating physician to require i.v. maintenance fluid administration for at least the following 24 h of their hospital stay will be eligible for inclusion in the study. |
|
| ExclusionCriteria |
| Details |
Children with hyponatraemia (plasma sodium <130 mEq/L), hypernatraemia (plasma sodium >150 mEq/L) or hyperglycaemia (blood glucose>180 mg/dL), dehydration, shock, severe malnutrition, cirrhosis of liver, congestive heart failure, acute or chronic renal failure and nephrotic syndrome will be excluded. Children who were receiving drugs that alter plasma sodium levels, such as frusemide, hydrochlorothiazide, vasopressin or desmopressin and mannitol, will also be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in sodium, potassium, chloride and bicarbonate after giving intravenous fluids. |
72 hours after starting IV fluids |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in urea and creatinine after giving intravenous fluids. |
72 hours after starting iv fluids |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/08/2015 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
No Publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Intravenous fluid
regimen and dyselectrolytemia among children
Balaji Chinnasami, Kanimozhi
Sadasivam, P. Sekar, Saravanan
Aim: The aim
of this study is to compare the effect of three different intravenous (i.v.)
fluid regimes I.e. Isolyte P, DNS and Plasma-Lyte 148 on the incidence of
dyselectrolytemia in hospitalized children ranging in age from 3 months to 12
years.
Brief Introduction: The administration of intravenous (i.v.) maintenance fluid is an
essential part of the management of sick children. In pediatric patients, the
administration of 0.18% saline in 5% dextrose as i.v. maintenance fluid is the
currently accepted standard practice despite there being concerns regarding the
potential for hospital-acquired hyponatraemia associated with hypotonic i.v.
fluid administration. In 2003, Moritz and Ayus introduced the concept of using
0.9% saline as a maintenance parenteral fluid for the prevention of hospital-acquired
hyponatraemia in children. However excessive use of saline has been observed to
result in hyperchloremic acidosis. It has been suggested that the use of
balanced solutions may avoid this effect. British Consensus Guidelines on
Intravenous Fluid therapy for Adult Surgical Patients clearly recommend the use
of balanced crystalloids rather than saline.
Study Design : It will
be a prospective study carried out on 150 children between 3mths to 12yrs of
age. The study will be conducted in department of pediatrics from August 2015
to Janauary 2015. Children who require the administration of i.v. maintenance
fluid for at least 24hrs following hospitalization will be eligible for
inclusion. After obtaining consent from parents the children will be randomized
into three i.v. fluid groups: Group A, 0.18% saline in 5% dextrose (Isolyte P);
Group B, Plasma-Lyte 148; Group C, 0.9% saline in 5% dextrose. All three groups
will be receiving fluids at standard maintenance rate.
Inclusion Criteria : Children
who are judged by the treating physician to require i.v. maintenance fluid
administration for at least the following 24 h of their hospital stay will be
eligible for inclusion in the study.
Exclusion Criteria : Children
with hyponatraemia (plasma sodium <130 mEq/L), hypernatraemia (plasma sodium
>150 mEq/L) or hyperglycaemia (blood glucose>180 mg/dL), dehydration,
shock, severe malnutrition, cirrhosis of liver, congestive heart failure, acute
or chronic renal failure and nephrotic syndrome will be excluded. Children who
were receiving drugs that alter plasma sodium levels, such as frusemide,
hydrochlorothiazide, vasopressin or desmopressin and mannitol, will also be
excluded.
Sample Size : Given
the sparse and conflicting data, we took the incidence of hospital-acquired
hyponatraemia among children to be 30%. Therefore, a sample of 72 patients
would be needed in each group to demonstrate a 10% decrease in the incidence of
hyponatraemia (defined as plasma sodium <130 mEq/L), with a power of 80% and
alpha error of 0.05. In view of feasibility, it was decided a priori to enroll
at least 50 patients in each treatment limb.
Outcome Measurement : At
enrolment, 2 mL of venous blood will be taken for estimation of plasma sodium,
potassium, chloride, blood sugar, urea and creatinine. Plasma sodium,
potassium, chloride, blood sugar levels will be estimated every day thereafter.
The study measurements will be carried out until the child received only i.v.
maintenance fluid therapy or at the 72-h time-point following the initiation of
the i.v. fluid therapy, whichever is earlier.
Analysis of Data : All
analyses will be performed on an intention to-treat basis. The outcomes in the
three groups will be compared. Proportions will be compared using Fisher’s
exact test or the chi-square test. Continuous variables in the three study
groups will be compared using Kruskal–Wallis’ test. |