Chloride Disorder, Fluid Overload, Fluid Retention, Potassium Disorders, Sodium Disorder, Thoracic Diseases, Water-Electrolyte Imbalance
Conditions
Keywords
Maintenance Fluid Therapy
Brief 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.
Interventions
DRUGNaCl 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.
DRUGGlucion 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
Niels Van Regenmortel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study fluids blinded using opaque bags
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluid balance | 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
| Measure | Time frame | Description |
|---|---|---|
| Vasopressor Use | 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 |
| Physiological Mechanisms: Aldosterone level | 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 |
| Physiological Mechanisms: Fractional Excretion of Sodium | 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 |
| Electrolyte Homeostasis and Disorders: Sodium | 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. |
| Electrolyte Homeostasis and Disorders: Potassium | 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. |
| Electrolyte Homeostasis and Disorders: Chloride | 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. |
| Resuscitation Fluids | 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 |
| Electrolyte Homeostasis and Disorders: Phosphate | 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. |
| Electrolyte Homeostasis and Disorders: Calcium | 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. |
| Clinical Endpoints: 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. | Mean postoperative paO2/FiO2 |
| Clinical Endpoints: occurrence of de novo atrial fibrillation | 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) |
| Clinical Endpoints: occurrence of acute kidney injury (AKI) | 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) |
| Sodium balance | 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. |
| Electrolyte Homeostasis and Disorders: Strong Ion Difference | 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. |
Countries
Belgium
Outcome results
None listed