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

NCT02054585 | Unknown

• 1 other identifier: CMC-13-0078-CTIL
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration

Keywords

dehydration; pediatric; glucose; IV fluid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• hypoglycemia

  2hs

Study Arms (2)

NaCl %0.9

ACTIVE COMPARATOR

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%

NaCl 0.9% +5% dextrose

EXPERIMENTAL

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.

Other: NaCl 0.9 +5% dextrose

Interventions

NaCl 0.9% 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

NaCl 0.9 +5% dextrose 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.

NaCl 0.9% +5% dextrose

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

RECRUITING

MeSH Terms

Conditions

Dehydration

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Rosana Sh Blejter Palti, MD

  Catmel Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosana Sh Blejter Palti, MD

CONTACT

00972546365444; rosiblejter@yahoo.com.ar

Muriel Konopnicki, MD

CONTACT

00972545580840; muriel_konop@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 2, 2014
• First Posted: February 4, 2014
• Study Start: July 15, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)