TOnicity of Perioperative Maintenance SoluTions

Study Overview
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Brief Summary
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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.

Official Title
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TOnicity of Perioperative Maintenance SoluTions - Part 1: Thoracic Surgery

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

Intervention / Treatment
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* Drug: NaCl 0.9% in Glucose 5% + 40mmol/L Potassium
* Drug: Glucion 5%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NaCl 0.9% in Glucose 5% + 40mmol/L Potassium<br> | Drug: NaCl 0.9% in Glucose 5% + 40mmol/L Potassium<br>* Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.<br>|
| Active Comparator: Glucion 5%<br> | Drug: Glucion 5%<br>* Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid balance | Difference between all fluid intake and output | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resuscitation Fluids | The cumulative amount of additional (resuscitation) fluids during the study period | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) | 
| Vasopressor Use | The cumulative amount of vasopressors during the study period | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) | 
| Physiological Mechanisms: Aldosterone level | Change from baseline aldosterone level at start of surgery | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points. | 
| Physiological Mechanisms: Fractional Excretion of Sodium | Change from baseline FeNa at start of surgery | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points. | 
| Electrolyte Homeostasis and Disorders: Sodium | Mean sodium level and change from baseline. Occurrence of hypo and hypernatremia. | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points. | 
| Electrolyte Homeostasis and Disorders: Potassium | Mean potassium level and change from baseline. Occurrence of hypo and hyperpotassemia. | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points. | 
| Electrolyte Homeostasis and Disorders: Chloride | Mean chloride level and change from baseline. Occurrence of hypo and hyperchloremia. | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points. | 
| Electrolyte Homeostasis and Disorders: Strong Ion Difference | Mean SID level and change from baseline. | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points. | 
| Electrolyte Homeostasis and Disorders: Phosphate | Mean phosphate level and change from baseline. Occurrence of hypo and hyperphosphatemia. | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points. | 
| Electrolyte Homeostasis and Disorders: Calcium | Mean calcium level and change from baseline. Occurrence of hypo and hypercalcemia. | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points. | 
| Clinical Endpoints: paO2/FiO2 | Mean postoperative paO2/FiO2 | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery) - Assessments at fixed time points. | 
| Clinical Endpoints: occurrence of de novo atrial fibrillation | occurrence of de novo atrial fibrillation (Y/N) | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery). Continuous assessment. | 
| Clinical Endpoints: occurrence of acute kidney injury (AKI) | AKI according to RIFLE-score creatinine and urine R-I-F) | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery). Continuous assessment. | 
| Sodium balance | Sodium balance (total in vs out) at end of study, assessed by urine collection. | From start of surgery until end of study, defined as one of the following (1) discharge from ICU (2) 8AM on third postoperative day (maximum: up to 72h after start of surgery). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maintenance Fluid Therapy