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TOnicity of Perioperative Maintenance SoluTions

NCT03080831 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-08-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Niels Van Regenmortel

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2018-07-15
Completion
2018-07-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03080831 on ClinicalTrials.gov