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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
70
Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.
Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.
University Hospital, Antwerp
Edegem, Belgium
Fluid balance
Difference between all fluid intake and output
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)
Resuscitation Fluids
The cumulative amount of additional (resuscitation) fluids during the study period
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)
Vasopressor Use
The cumulative amount of vasopressors during the study period
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)
Physiological Mechanisms: Aldosterone level
Change from baseline aldosterone level at start of surgery
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.
Physiological Mechanisms: Fractional Excretion of Sodium
Change from baseline FeNa at start of surgery
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.
Electrolyte Homeostasis and Disorders: Sodium
Mean sodium level and change from baseline. Occurrence of hypo and hypernatremia.
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.
Electrolyte Homeostasis and Disorders: Potassium
Mean potassium level and change from baseline. Occurrence of hypo and hyperpotassemia.
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.
Electrolyte Homeostasis and Disorders: Chloride
Mean chloride level and change from baseline. Occurrence of hypo and hyperchloremia.
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.
Electrolyte Homeostasis and Disorders: Strong Ion Difference
Mean SID level and change from baseline.
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.
Electrolyte Homeostasis and Disorders: Phosphate
Mean phosphate level and change from baseline. Occurrence of hypo and hyperphosphatemia.
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.
Electrolyte Homeostasis and Disorders: Calcium
Mean calcium level and change from baseline. Occurrence of hypo and hypercalcemia.
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.
Clinical Endpoints: paO2/FiO2
Mean postoperative 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.
Clinical Endpoints: occurrence of de novo atrial fibrillation
occurrence of de novo atrial fibrillation (Y/N)
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.
Clinical Endpoints: occurrence of acute kidney injury (AKI)
AKI according to RIFLE-score creatinine and urine R-I-F)
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.
Sodium balance
Sodium balance (total in vs out) at end of study, assessed by urine collection.
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).
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