| CTRI Number |
CTRI/2015/01/005481 [Registered on: 30/01/2015] Trial Registered Prospectively |
| Last Modified On: |
08/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Intravenous fluid for children with acute diarrhea |
|
Scientific Title of Study
|
Ringer’s lactate versus normal saline for children with severe dehydration due to acute diarrhea: A randomized double blind controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayathri Bhuvaneswaran Kartha |
| Designation |
Junior Resident Pediatrics |
| Affiliation |
JIPMER |
| Address |
Department of Pediatrics,
JIPMER Women and Children Hospital,
Dhanvantari Nagar Post
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8870069729 |
| Fax |
|
| Email |
oracleundefied@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Kumar R |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Pediatrics,
JIPMER Women and Children Hospital,
Dhanvantari Nagar Post
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7373739142 |
| Fax |
|
| Email |
krramesh_iway@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Kumar R |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Pediatrics,
JIPMER Women and Children Hospital,
Dhanvantari Nagar Post
PONDICHERRY
605006
India |
| Phone |
7373739142 |
| Fax |
|
| Email |
krramesh_iway@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
The Director |
| Address |
JIPMER
Dhanvantari Nagar Post,
Puducherry 605006 |
| 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 Gayathri Bhuvaneswaran Kartha |
Department of Pediatrics |
JIPMER Women and Children Hospital,
Dhanvantari Nagar Post,
Puducherry
Pondicherry
PONDICHERRY |
8870069729
oracleundefied@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children 1 month to 12 years with severe dehydration due to acute diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline |
Normal saline 100 ml per kg over 6 hours in children less than 1 year or over 3 hours in children 1 to 12 years infused |
| Intervention |
Ringers Lactate |
Ringers Lactate 100 ml per kg over 6 hours in children less than 1 year or over 3 hours in children 1 to 12 years infused |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 month to 12 years diagnosed severe dehydration due to acute diarrhea as per WHO criteria: Acute diarrhea will be defined as more or equal 3 loose or watery or liquid or semiliquid stools in 24 hours. Severe dehydration will be defined as presence of hypotension i.e mean arterial blood pressure less than 5th percentile for age, sex and height or any of the two out of four signs - lethargic or unconscious, sunken eyeballs, drinks poorly or not able to drink, skin pinch goes back very slowly more than 2 seconds) |
|
| ExclusionCriteria |
| Details |
1. Duration of diarrhea more than 7 days
2. Bloody diarrhea
3. Severe malnutrition as per WHO criteria (Symmetrical oedema, Weight-for-height: SD-score less than −3 (less than70%) (Severe wasting)and or
Height-for-age: SD-score less than −3 (less than 85%) (Severe stunting).
4. Known systemic disease (cardiac, endocrine, neurologic, chronic renal failure)
5. Lethal malformations
6. Children who have already received RL or NS during this episode. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correction of severe dehydration in children with acute watery diarrhea, as measured by clinical signs of dehydration and improvement in pH |
at end of 6 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • The changes in the serum electrolytes -sodium, potassium, chloride, bicarbonate, base-deficit and anion-gap |
at end of 6 hours |
| • The amount of fluid required to correct severe dehydration excluding first cycle of correction |
at end of dehydration correction (approximately 12 hours) |
| • Time taken to start oral feeding |
at end of dehydration correction (approximately 6 hours) |
| • Length of hospital stay |
Till discharge from hospital (approximately 5 days) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Kartha GB, Rameshkumar R, Mahadevan S. Randomized Double-blind Trial of Ringer Lactate Versus Normal Saline in Pediatric Acute Severe Diarrheal Dehydration. J Pediatr Gastroenterol Nutr. 2017;65(6):621-626. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Eligible children will be randomly assigned to receive either RL or NS. Intravenous fluid therapy will be instituted according to WHO acute diarrheal illness management guidelines (PLAN C). Children 1 month to 1 year will receive fluid correction over six hours (first 30ml/kg over 1hour, followed by 70ml/kg over 5 hours) and children more than 1 year old will receive correction over three hours (first 30ml/kg over 30 minutes, followed by 70ml/kg over 2 hours 30 minutes). They will be monitored continuously for vital signs and will be reassessed at end of 100 mL/kg infusion for clinical signs of dehydration. If any child will be found to be in severe dehydration at the end of the first correction, intravenous rehydration (100 mL/kg) will be repeated. If they will be found to have no features of severe dehydration, further management will be based on the existing WHO guidelines for treatment of some dehydration (PLAN B) and no dehydration (PLAN A). Before and At the end of 6 hours blood gas, serum electrolytes, blood urea and creatinine will be measured. Clinical features, lab reports, volume of fluid needed to correct severe dehydration will be noted. The trial had to be stopped after an interim analysis by the independent data monitoring committee indicated the futility of continuing the study further with respect to primary endpoint.
|