TOnicity of Perioperative Maintenance SoluTions - Clinical Trial for Thoracic Diseases | NCT03080831

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

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

Glucion 5%

About this trial

This is an interventional supportive care trial for Thoracic Diseases focused on measuring Maintenance Fluid Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital, Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

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

Glucion 5%

Arm Description

Outcomes

Primary Outcome Measures

Fluid balance

Difference between all fluid intake and output

Secondary Outcome Measures

Resuscitation Fluids

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

Vasopressor Use

The cumulative amount of vasopressors during the study period

Physiological Mechanisms: Aldosterone level

Change from baseline aldosterone level at start of surgery

Physiological Mechanisms: Fractional Excretion of Sodium

Change from baseline FeNa at start of surgery

Electrolyte Homeostasis and Disorders: Sodium

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

Electrolyte Homeostasis and Disorders: Potassium

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

Electrolyte Homeostasis and Disorders: Chloride

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

Electrolyte Homeostasis and Disorders: Strong Ion Difference

Mean SID level and change from baseline.

Electrolyte Homeostasis and Disorders: Phosphate

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

Electrolyte Homeostasis and Disorders: Calcium

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

Clinical Endpoints: paO2/FiO2

Mean postoperative paO2/FiO2

Clinical Endpoints: occurrence of de novo atrial fibrillation

occurrence of de novo atrial fibrillation (Y/N)

Clinical Endpoints: occurrence of acute kidney injury (AKI)

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

Sodium balance

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

Full Information

NCT ID

NCT03080831

First Posted

February 19, 2017

Last Updated

August 10, 2018

Sponsor

Niels Van Regenmortel

1. Study Identification

Unique Protocol Identification Number

NCT03080831

Brief Title

TOnicity of Perioperative Maintenance SoluTions

Acronym

TOPMAST-1

Official Title

TOnicity of Perioperative Maintenance SoluTions - Part 1: Thoracic Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

March 9, 2017 (Actual)

Primary Completion Date

July 15, 2018 (Actual)

Study Completion Date

July 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Niels Van Regenmortel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Maintenance Fluid Therapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Study fluids blinded using opaque bags

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Title

Glucion 5%

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

Glucion 5%

Intervention Description

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 Outcome Measure Information:

Title

Fluid balance

Description

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)

Secondary Outcome Measure Information:

Title

Resuscitation Fluids

Description

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)

Title

Vasopressor Use

Description

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)

Title

Physiological Mechanisms: Aldosterone level

Description

Change from baseline aldosterone level at start of surgery

Time Frame