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

NCT ID: NCT02054585

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-15
• Study Completion Date: 2019-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

NaCl 0.9%

Intervention Type: OTHER

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.

NaCl 0.9% +5% dextrose

Children 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.

Group Type: EXPERIMENTAL

NaCl 0.9 +5% dextrose

Intervention Type: OTHER

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% + 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.

Interventions

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.

Intervention Type: OTHER

NaCl 0.9 +5% dextrose

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% + 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rosana Blejter Palti

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosana Sh Blejter Palti, MD

Role: PRINCIPAL_INVESTIGATOR

Catmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Rosana Sh Blejter Palti, MD

Role: CONTACT

rosiblejter@yahoo.com.ar

00972546365444

Muriel Konopnicki, MD

Role: CONTACT

muriel_konop@yahoo.fr

00972545580840

Other Identifiers

CMC-13-0078-CTIL

Identifier Type: -

Identifier Source: org_study_id