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.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | August 2019 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility |
Inclusion Criteria: - children aged 6 month to 18 years suffering dehydration according to clinical criteria who are unable to drink or are vomiting with or without diarrhea who's parents signed an informed consent form. clinical criteria for dehydration: elevated heart rate (according to age normal values), reduced urine output, dry mucosa. In children younger than 2 years old also: sunken ayes, sunken fontanels, tearless crying, reduced turgor. Exclusion Criteria: - children who's first blood glucose measure is below 60 mg/dl - children who's first blood glucose measure is above 180 mg/dl - children with metabolic or neurologic disease as a cause of vomiting - children who need to be hospitalizes for surgery or IV antibiotics |
Country | Name | City | State |
---|---|---|---|
Israel | Carmel Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Carmel Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hospitalization | Primary aim: to compare the number of hospitalizations among dehydrated pediatric patients treated with NaCl 0.9% VS NaCl 0.9% + 5% dextrose | 24 h | |
Secondary | hypoglycemia | To evaluate for the possibility of hypoglycemia secondary to hyperinsulinism as a response to a fast administration of glucose. | 2hs |
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