Short-term effects of commonly used solutions for intravenous hydration of children with gastroenteritis on the acids, fats and sugars in the blood

Phase 1

• Conditions: Dehydration and metabolic acidosis due to acute gastroenteritis; MedDRA version: 20.0Level: PTClassification code 10012174Term: DehydrationSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-000367-25-IT
• Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Otherwise healthy children 4 months to 5 years of age with acuta gastroenteritis, moderate-severe dehydrataion (according to the clinical dehydration scale) and metabolic acidosis
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Principal exclusion criteria (up to 4000 characters): hemodynamic instability, hypoglycemia (blood glucose <50 mg/dL), ipo (K <3.0 mEq/L) or hyper-kalemia (K>5.5 mEq/L), severe hypercalcemia (Ca++ > 1.4 mEq/L), chronic metabolic or renal diseases or chronic steroids treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Test the effect of the three commonly used intravenous rehydration solutions on acid-base balance (especially circulating bicarbonate) after 3 hours of infusion;Secondary Objective: Test the effect of the three commonly used intravenous rehydration solutions on free-fatty acids and glucose metabolism after 1,3 and 6 hours of infusion<br>Test the effect of the three commonly used intravenous rehydration solutions on acid-base balance (especially circulating bicarbonate) after 1 and 6 hours of infusion;Primary end point(s): evaluating the bicarbonate levels after 3 hours of infusion;Timepoint(s) of evaluation of this end point: 3 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): evaluation of free-fatty acids and glucose after 1, 3 and 6 hours of infusion. Evaluation of bicarbonate levels after 1 and 6 hours of infusion.;Timepoint(s) of evaluation of this end point: 1, 3 and 6 hours