CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 258 enrolled
Drug / intervention
0.9% NaCl +1 moredrug
Likely dose
0.45%NaClfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00734214
NCT00734214Phase 3Completed

Hypotonic Versus Isotonic Parenteral Fluids in Children - a Randomized Controlled Trial

Hamilton Health Sciences Corporation·interventional·Posted Aug 14, 2008·Updated Apr 29, 2015

In Brief

A Phase 3 clinical trial evaluating 0.9% NaCl and 0.45%NaCl for Hyponatremia and Hypernatremia. Completed, enrolled 258 participants across 1 site.

Detailed Summary

Children who are undergoing surgery need intravenous fluids to prevent dehydration and maintain their electrolyte balance. The current standard of care in these children is to use a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been tested. There is ongoing concern from the medical community that this type of fluid increases the child's risk of developing low sodium levels, and hence may not be safe for all children. Low sodium can lead to significant complications such as seizures, coma and even death, risks of which are often underestimated and not anticipated by their caregivers. Experts in the field suggest that giving a solution with a similar sodium content to that of blood (isotonic fluid) reduces the risk of these problems in these children. This study will compare these two types of intravenous fluids (hypotonic versus isotonic), in a blinded fashion (i.e. neither the patient nor caregivers or investigators will be aware which type of fluid the patient is receiving), in children following surgery. The investigators goal is to see which type of fluid is safer, and leads to more stable sodium levels. This would in turn lead to a lower risk of complications as described above. This is the first time such a study is preformed in pediatrics. There are unnecessary number of complications and potential deaths from this disorder, and hence the safety of everyday fluid practice in children needs to be scientifically tested. The results of this study will enable the investigators to propose scientifically based guidelines on how to minimize risks associated with intravenous infusions in children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 14, 2008
Enrollment StartMar 1, 2008
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.9 years ago

Interventions

0.9% NaCldrug

Intravenous Fluid Isotonic Parenteral Fluid

0.45%NaCldrug

Intravenous Fluid Hypotonic Parenteral Fluid