TOnicity of Perioperative Maintenance SoluTions (TOPMAST-1)

Niels Van Regenmortel

Status and phase: Completed; Phase 4

Conditions: Water-Electrolyte Imbalance; Chloride Disorder; Fluid Retention; Potassium Disorders; Thoracic Diseases; Sodium Disorder; Fluid Overload

Treatments: Drug: Glucion 5%; Drug: NaCl 0.9% in Glucose 5% + 40mmol/L Potassium

Study type: Interventional

Funder types: Other

Identifiers

NCT03080831

17/4/34

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (at least 18 y.o.)
• Undergoing elective lung resection (wedge resection, segmental resection, (bi)lobectomy, but not pneumonectomy) via thoracotomy or video- or robot assisted (VATS, RATS)
• Normal renal function (eGFR >60 ml/min/1.73m² (CKD-EPI))

Exclusion criteria

• Under chronic treatment with diuretics or desmopressin
• Heart failure (NYHA III-IV)
• Liver Failure
• Brittle diabetes mellitus
• Neurological contra-indication for hypotonic fluids
• SIADH or hyponatremia <130 or > 150 mmol/L at preoperative assessment
• Hyperkalemia > 5 mmol/L at preoperative assessment
• Under treatment with artificial nutrition (enteral or parenteral)
• Pregnancy

Additional pre-defined exclusion after initial inclusion

• Massive perioperative transfusion or intraoperative resuscitation of +2.5L of crystalloids/colloids
• Absence of admission to ICU

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

NaCl 0.9% in Glucose 5% + 40mmol/L Potassium

Active Comparator group

Treatment:

Drug: NaCl 0.9% in Glucose 5% + 40mmol/L Potassium

Glucion 5%

Active Comparator group

Treatment:

Drug: Glucion 5%