Dehydration Clinical Trial
Official title:
Intravenous Fluids With or Without Dextrose as Treatment for Dehydration in Children. What's the Formula That Will Bring to a Faster Improvement? A Prospective Randomized Double Blinded Study.
Dehydration and refusal to eat and drink are common complaints in the Pediatric ED
(Emergency Department). Most of these children have had an unsuccessful trial of oral
rehydration in their community service, therefore are treated with IV rehydration. There is
no consensus as to which IV solution is the best one for rehydration. Children who are
unwilling or unable to eat and drink produce Keto bodies. Theoretically, addition of glucose
to the IV solution would prevent catabolic metabolism and reduce the keto bodies blood
concentration which should lead to a faster objective and subjective improvement of the
child's condition.
The proposed study is a double blind randomized clinical trial. Children will receive either
NaCl 0.9% or NaCl 0.9% + 5% glucose randomly in numbered bags. The type of solution will be
known to the pharmacy only.
Study aims:
- Primary aim: to compare the number of hospitalizations among dehydrated pediatric
patients treated with either one of the IV fluids mentioned above.
- Secondary aim: To evaluate for the possibility of hypoglycemia secondary to
hyperinsulinism as a response to a rapid administration of glucose.
Study population: The study will include 700 children 6 month to 18 years of age. It will be
conducted over 18 months in the Pediatric ED of Carmel Medical Center.
Currently, data regarding the use of dextrose containing solutions is lacking. As
dehydration is one of the most common medical problems encountered by the physician in the
pediatric ED, it is of outmost importance to evaluate the optimal IV solution used in this
setting.
This is a prospective randomized double blind study. 700 children 6 months to 18 years of
age who are dehydrated and are unable to drink and who's parents sign an informed consent
form will participate in this study (see inclusion and exclusion criteria). Our pharmacy
department will prepare identical bags half of which will contain NaCl 0.9% and the other
half NaCl 0.9% + 5% dextrose. The bags will be randomly numbered using SAS (Statistical
analysis system). Only the pharmacy department will know the content of each bag. The
children will receive a bolus of 20 mL/Kg of IV fluid. A repeat bolus will be given
according to clinical decision from the same bag. A blood glucose level will be taken 2
hours after initiation of the study with a glucometer in order to ascertain that no
hypoglycemia is occurring secondary to hyperinsulinism because of fast glucose
administration. A urine test in order to check the presence of ketones will also be done.
The end point of this study is the moment the physician decides whether to hospitalize or to
release the patient from the ER. On the day following his visit to the emergency department,
parents will be asked to answer a questionnaire about the child's well being. The
questionnaire will be completed in the hospital if the child was admitted or by telephone if
the child was discharged.
In addition to the inclusion and exclusion criteria, children in whom an IV catheter could
not be introduced, children who's blood glucose after 2 hours of fluid IV administration is
below 60 mg/dl or in whom a need for IV antibiotics or surgical intervention will be decided
during the ER stay will be taken out of the study.
The data will be analyzed using PASW (predictive analysis software) statistics.
Chi square will be used in order to check statistically significant differences between both
groups.
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