At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
TOnicity of Perioperative Maintenance SoluTions - Part 1: Thoracic Surgery
In Brief
A Phase 4 clinical trial evaluating NaCl 0.9% in Glucose 5% + 40mmol/L Potassium and Glucion 5% for Thoracic Diseases and 6 related conditions. Completed, enrolled 70 participants across 1 site.
Detailed Summary
Prospective randomized double blind phase IV trial studying the efficacy and safety of the tonicity of two different perioperative maintenance solutions: an isotonic solution containing NaCl 0.9 in glucose 5% with an added 40 mmol/L of potassium or a commercially available premixed solution (Glucion 5%) containing a.o. 54 mmol/L of sodium and 26 mmol/L of potassium. Both solutions are administered at 27 mL/kg of ideal body weight, as recommended by current guidelines (NICE 174) and both solutions are widely used in daily clinical practice. The primary hypothesis is that isotonic maintenance solutions lead to more fluid retention than hypotonic fluids. Metabolism of both solutions is assessed by sequential analysis of urine and serum and clinical parameters.
Study Details
Timeline
Interventions
Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.
Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.