Hospital de Niños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., C1270AAN, Argentina
NCT Number: NCT01251770
The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.
Looking for future studies?
Notify Me1 month–16 year
All sexes
Interventional
Phase 3
Buenos Aires, Buenos Aires F.D., C1270AAN, Argentina
Background: Despite prescription of maintenance IV fluids in hospitalized children is widely used since 1957 (Holiday & Segar), it is not always adequate for children with acute diseases, leading to hyponatremia. This mainly occurs due to a non-physiologic ADH secretion in this group of patients due to nausea, stress, pain, and surgical interventions, and the use of hypotonic maintenance IV fluids.
0.3% NaCl/dextrose 5%, is widely use as IV maintenance fluid in children after surgery. There is evidence suggesting that these IV fluids used in postsurgical hospitalized patients do not provide the adequate amount of sodium they require, leading to an increased risk of developing hyponatremia. Using 0.45% NaCl/dextrose 5% as IV maintenance fluid in these children would prevent hyponatremia, but this treatment has not been totally studied yet.
Study procedures: Hospitalized children who fulfill inclusion criteria and not having any of the exclusion criteria will be considered for the enrolment after written informed consent.
Venous blood samples will be taken at enrollment (baseline) for estimation of serum sodium. After randomization, one group will receive 0.3% NaCl/dextrose 5%, IV, at standard maintenance rate (100 ml/kg for the first 10 kg of body weight, 50 ml/kg for the next 10 kg, and 20 ml/kg for body weight exceeding 20 kg). The second group will receive 0.45% NaCl/dextrose 5%, IV, at the same rate.
Serum sodium will be estimated in both groups after 12 hours of intravenous fluid therapy.
Children who required oral fluids will be excluded from per-protocol analysis, and only analyzed for intention to treat.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid administration is anticipated to be intravenous, in the first 12 hours following surgery.
Informed consent of parent/guardian.
Exclusion criteria
Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 body surface.
Other names: half saline
Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 surface.
Other names: third saline
Time frame: Change from baseline in sodium level after 12 hours
Time frame: 12 hours from baseline
Hospital General de Niños Pedro de Elizalde
Other
Acronym: surgical-Na
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06408077
Hyponatremia, Metabolic Diseases
Cologne, Germany
View Trial DetailsNCT06013800
Hyponatremia, Metabolic Diseases
Veracruz, Mexico
View Trial DetailsNCT00201994
Brain Diseases, Cardiovascular Diseases
Gustav Carus, Dresden, Germany
View Trial DetailsNCT06781710
Demyelinating Diseases, Hyponatremia
Cologne, Germany
View Trial Details