NCT03080831

TOnicity of Perioperative Maintenance SoluTions

TOnicity of Perioperative Maintenance SoluTions - Part 1: Thoracic Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Niels Van Regenmortel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracic Diseases
• Water-Electrolyte Imbalance
• Fluid Overload
• Fluid Retention
• Sodium Disorder
• Potassium Disorders
• Chloride Disorder

Interventions

Type	Name	Description
DRUG	NaCl 0.9% in Glucose 5% + 40mmol/L Potassium	Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.
DRUG	Glucion 5%	Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.

Timeline

• Start date: 2017-03-09
• Primary completion: 2018-07-15
• Completion: 2018-07-15
• First posted: 2017-03-15
• Last updated: 2018-08-14

Locations

1 site across 1 country: Belgium