FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 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  
Status 
Not Applicable 
 
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. 
Close