| CTRI Number |
CTRI/2010/091/000398 [Registered on: 24/12/2010] |
| Last Modified On: |
09/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study two different types of intravenous fluids for maintenance fluid treatment of children |
Scientific Title of Study
Modification(s)
|
Randomized Controlled Trial Comparing Isotonic and Hypotonic Intravenous Fluids for Maintenance Fluid Therapy in 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. Kamran Afzal |
| Designation |
|
| Affiliation |
|
| Address |
Department of Pediatrics
Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
0571-2721182 |
| Fax |
NIL |
| Email |
drkafzal@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kamran Afzal |
| Designation |
|
| Affiliation |
Reader, Department of Pediatrics |
| Address |
Department of Pediatrics
Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
0571-2721182 |
| Fax |
NIL |
| Email |
drkafzal@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kamran Afzal |
| Designation |
|
| Affiliation |
|
| Address |
Department of Pediatrics
Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
0571-2721182 |
| Fax |
NIL |
| Email |
drkafzal@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Aligarh Muslim University,
Aligarh,
U.P, India |
| Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
Modification(s)
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Kamran Afzal |
Department of Pediatrics, J.N.Medical College |
Department of Pediatrics, J.N.Medical College,A.M.U-202002
Aligarh
UTTAR PRADESH |
0571-2721182
NIL
drkafzal@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E871||Hypo-osmolality and hyponatremia, (2) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hypotonic Saline Solution (0.18% NaCl Solution In 5% Dextrose |
100% Of The Maintenance Fluid Requirement (Calculated By Holiday And Segar Formula) for 48 hours |
| Intervention |
Isotonic Saline Solution (0.9% NaCl Solution In 5% Dextrose) |
60% Of The Maintenance Fluid Requirement (Calculated By Holiday And Segar Formula) for 48 hours |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.50 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children in the age group of 0.5 to 12 years who are admitted and anticipated to receive intravenous fluid for the next 48 hours |
|
| ExclusionCriteria |
| Details |
1)Baseline serum sodium concentration less than 130 mmol/L or greater than 150 mmol/L
2)Hemodynamically unstable patients: shock, myocarditis, congestive heart failure
3)Acute gastroenteritis with dehydration
4)If intravenous fluid has been administered within the 3 hours preceding the study
5)Acute or chronic kidney disease, a history/evidence of cardiac dysfunction, severe chronic neurological illnesses (uncontrolled seizure disorders, severe developmental delay), diabetes mellitus or insipidus
6)Pre-existing hypertension, diuretic use, edema, or known adrenal dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Incidence of hyponatremia |
24 and 48 hours after initiating intervention |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Blood: sodium,potassium, chloride, pH, urea, serum creatinine. Urine output,weight |
12 hourly |
| Serum osmolality |
24 hourly |
| Manifestations attributable to dysnatremias,Case fatality rate |
During the study observation period |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/11/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a unmasked randomized controlled trial comparing the safety and efficacy of reduced volume isotonic versus standard volume hypotonic maintenance fluid in sick children between 0.5 to 12 years of age to observe the incidence of hyponatraemia (serum sodium <130 mEq/l) and/or hypernatraemia (serum sodium >150 mEq/l)and variations in serum sodium, serum osmolality, weight, urine output, and final clinical outcome with the use of the two types of maintenance fluids. |