Clinical trial NCT03080831: TOnicity of Perioperative Maintenance SoluTions
Official title: TOnicity of Perioperative Maintenance SoluTions - Part 1: Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thoracic Diseases
Water-Electrolyte Imbalance
Fluid Overload
Fluid Retention
Sodium Disorder
Potassium Disorders
Chloride Disorder
Keywords: Maintenance Fluid Therapy
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fluid balance
timeFrame: 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 outcomes:
measure: Resuscitation Fluids
timeFrame: 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)
measure: Vasopressor Use
timeFrame: 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)
measure: Physiological Mechanisms: Aldosterone level
timeFrame: 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.
measure: Physiological Mechanisms: Fractional Excretion of Sodium
timeFrame: 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.
measure: Electrolyte Homeostasis and Disorders: Sodium
timeFrame: 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.
measure: Electrolyte Homeostasis and Disorders: Potassium
timeFrame: 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.
measure: Electrolyte Homeostasis and Disorders: Chloride
timeFrame: 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.
measure: Electrolyte Homeostasis and Disorders: Strong Ion Difference
timeFrame: 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.
measure: Electrolyte Homeostasis and Disorders: Phosphate
timeFrame: 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.
measure: Electrolyte Homeostasis and Disorders: Calcium
timeFrame: 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.
measure: Clinical Endpoints: paO2/FiO2
timeFrame: 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.
measure: Clinical Endpoints: occurrence of de novo atrial fibrillation
timeFrame: 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.
measure: Clinical Endpoints: occurrence of acute kidney injury (AKI)
timeFrame: 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.
measure: Sodium balance
timeFrame: 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).
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital, Antwerp
Study officials:
References:
citation: Lobo DN, Bostock KA, Neal KR, Perkins AC, Rowlands BJ, Allison SP. Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial. Lancet. 2002 May 25;359(9320):1812-8. doi: 10.1016/S0140-6736(02)08711-1.
citation: Moritz ML, Ayus JC. Maintenance Intravenous Fluids in Acutely Ill Patients. N Engl J Med. 2015 Oct;373(14):1350-60. doi: 10.1056/NEJMra1412877. No abstract available.