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NCT Number: NCT03080831

TOnicity of Perioperative Maintenance SoluTions

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.

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Key information

Conditions

Thoracic Diseases Chloride Disorder Edema Fluid Overload Fluid Retention Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Potassium Disorders Respiratory Tract Diseases Signs and Symptoms Sodium Disorder Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Antwerp

Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.

Glucion 5%

Drug

Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.

Primary outcomes

  1. Fluid balance

    Time frame: 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)

    Difference between all fluid intake and output

Secondary outcomes

  1. Resuscitation Fluids

    Time frame: 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)

    The cumulative amount of additional (resuscitation) fluids during the study period

  2. Vasopressor Use

    Time frame: 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)

    The cumulative amount of vasopressors during the study period

  3. Physiological Mechanisms: Aldosterone level

    Time frame: 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.

    Change from baseline aldosterone level at start of surgery

  4. Physiological Mechanisms: Fractional Excretion of Sodium

    Time frame: 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.

    Change from baseline FeNa at start of surgery

  5. Electrolyte Homeostasis and Disorders: Sodium

    Time frame: 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.

    Mean sodium level and change from baseline. Occurrence of hypo and hypernatremia.

  6. Electrolyte Homeostasis and Disorders: Potassium

    Time frame: 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.

    Mean potassium level and change from baseline. Occurrence of hypo and hyperpotassemia.

  7. Electrolyte Homeostasis and Disorders: Chloride

    Time frame: 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.

    Mean chloride level and change from baseline. Occurrence of hypo and hyperchloremia.

  8. Electrolyte Homeostasis and Disorders: Strong Ion Difference

    Time frame: 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.

    Mean SID level and change from baseline.

  9. Electrolyte Homeostasis and Disorders: Phosphate

    Time frame: 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.

    Mean phosphate level and change from baseline. Occurrence of hypo and hyperphosphatemia.

  10. Electrolyte Homeostasis and Disorders: Calcium

    Time frame: 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.

    Mean calcium level and change from baseline. Occurrence of hypo and hypercalcemia.

  11. Clinical Endpoints: paO2/FiO2

    Time frame: 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.

    Mean postoperative paO2/FiO2

  12. Clinical Endpoints: occurrence of de novo atrial fibrillation

    Time frame: 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.

    occurrence of de novo atrial fibrillation (Y/N)

  13. Clinical Endpoints: occurrence of acute kidney injury (AKI)

    Time frame: 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.

    AKI according to RIFLE-score creatinine and urine R-I-F)

  14. Sodium balance

    Time frame: 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).

    Sodium balance (total in vs out) at end of study, assessed by urine collection.

Sponsors and collaborators

Lead sponsor

Niels Van Regenmortel

Other

Registry information

Official study title

TOnicity of Perioperative Maintenance SoluTions - Part 1: Thoracic Surgery

Acronym: TOPMAST-1

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2017
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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