TOnicity of Perioperative Maintenance SoluTions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2018-07-15

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study fluids blinded using opaque bags

Study Groups

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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%

Group Type ACTIVE_COMPARATOR

Glucion 5%

Intervention Type 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.

Interventions

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NaCl 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.

Intervention Type DRUG

Glucion 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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No