PatientsVille.com LogoPatientsVille.com

Dehydration | IV NaCl (Sodium Chloride) 0.9% Vs (Versus) IV NaCl 0.9% + 5% Dextrose in Pediatric ER for Dehydration

Dehydration research study

What is the primary objective of this 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dehydration

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:NaCl 0.9%Children will be included in each group in a randomized way using SAS (Statistical Analysis System) program. Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid.

Other:NaCl 0.9 +5% dextroseChildren will be included in each group in a randomized way using SAS (Statistical Analysis System) program. Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% + 5% dextrose. The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

NaCl %0.9Children will be included in each group in a randomized way using SAS (Statistical Analysis System) program. Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid.

NaCl 0.9% +5% dextroseChildren will be included in each group in a randomized way using SAS program. Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% + 5% glucose. The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid.

Study Status

Recruiting

Start Date: July 15, 2014

Completed Date: August 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: hospitalization

Secondary Outcome: hypoglycemia

Study sponsors, principal investigator, and references

Principal Investigator: Rosana Sh Blejter Palti, MD

Lead Sponsor: Carmel Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02054585

Discuss Dehydration