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

Acute effect of parenteral rehydration solution commonly used in children with acute gastroenteritis on acid-base balance, free-fatty acids metabolism and glucose homeostasis - Effect of rehydration on bicarbonatemia, circulating fatty acids and glycemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000367-25-IT

Enrollment

Registered

2021-05-20

Start date

2019-04-17

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration and metabolic acidosis due to acute gastroenteritis MedDRA version: 20.0 Level: PT Classification code 10012174 Term: Dehydration System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: SODIO CLORURO Product Code: [SODIO CLORURO] Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Sodio cloruro CAS Number: 7647-14-5 Current Sponsor code: Sodi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Principal exclusion criteria (up to 4000 characters): hemodynamic instability, hypoglycemia (blood glucose 5.5 mEq/L), severe hypercalcemia (Ca++ > 1.4 mEq/L), chronic metabolic or renal diseases or chronic steroids treatment.

Design outcomes

Primary

Measure	Time frame
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 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	—

Measure

Time frame

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 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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactUOC Pronto Soccorso Pediatrico

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO

gregorio.milani@unimi.it0255032066

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026