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TOnicity of Perioperative Maintenance SoluTions (TOPMAST-1)

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ClinicalTrials.gov Identifier: NCT03080831
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Niels Van Regenmortel, University Hospital, Antwerp

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.

Condition or disease Intervention/treatment Phase
Thoracic Diseases Water-Electrolyte Imbalance Fluid Overload Fluid Retention Sodium Disorder Potassium Disorders Chloride Disorder Drug: NaCl 0.9% in Glucose 5% + 40mmol/L Potassium Drug: Glucion 5% Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study fluids blinded using opaque bags
Primary Purpose: Supportive Care
Official Title: TOnicity of Perioperative Maintenance SoluTions - Part 1: Thoracic Surgery
Actual Study Start Date : March 9, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Active Comparator: NaCl 0.9% in Glucose 5% + 40mmol/L Potassium Drug: 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.

Active Comparator: Glucion 5% 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.




Primary Outcome Measures :
  1. Fluid balance [ 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) ]
    Difference between all fluid intake and output


Secondary Outcome Measures :
  1. Resuscitation Fluids [ 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) ]
    The cumulative amount of additional (resuscitation) fluids during the study period

  2. Vasopressor Use [ 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) ]
    The cumulative amount of vasopressors during the study period

  3. Physiological Mechanisms: Aldosterone level [ 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. ]
    Change from baseline aldosterone level at start of surgery

  4. Physiological Mechanisms: Fractional Excretion of Sodium [ 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. ]
    Change from baseline FeNa at start of surgery

  5. Electrolyte Homeostasis and Disorders: Sodium [ 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. ]
    Mean sodium level and change from baseline. Occurrence of hypo and hypernatremia.

  6. Electrolyte Homeostasis and Disorders: Potassium [ 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. ]
    Mean potassium level and change from baseline. Occurrence of hypo and hyperpotassemia.

  7. Electrolyte Homeostasis and Disorders: Chloride [ 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. ]
    Mean chloride level and change from baseline. Occurrence of hypo and hyperchloremia.

  8. Electrolyte Homeostasis and Disorders: Strong Ion Difference [ 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. ]
    Mean SID level and change from baseline.

  9. Electrolyte Homeostasis and Disorders: Phosphate [ 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. ]
    Mean phosphate level and change from baseline. Occurrence of hypo and hyperphosphatemia.

  10. Electrolyte Homeostasis and Disorders: Calcium [ 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. ]
    Mean calcium level and change from baseline. Occurrence of hypo and hypercalcemia.

  11. Clinical Endpoints: 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. ]
    Mean postoperative paO2/FiO2

  12. Clinical Endpoints: occurrence of de novo atrial fibrillation [ 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. ]
    occurrence of de novo atrial fibrillation (Y/N)

  13. Clinical Endpoints: occurrence of acute kidney injury (AKI) [ 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. ]
    AKI according to RIFLE-score creatinine and urine R-I-F)

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080831


Locations
Belgium
University Hospital, Antwerp Recruiting
Edegem, Belgium, 2650
Contact: Niels Van Regenmortel, M.D.    0032484770751    niels.vanregenmortel@uza.be   
Contact: Philippe Jorens, M.D.;Ph.D.    003232173639    philippe.jorens@uza.be   
Principal Investigator: Niels Van Regenmortel, M.D.         
Sponsors and Collaborators
Niels Van Regenmortel

Additional Information:
Publications:
Responsible Party: Niels Van Regenmortel, Dr., University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03080831     History of Changes
Other Study ID Numbers: 17/4/34
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymized data available on reasonable request

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

Keywords provided by Niels Van Regenmortel, University Hospital, Antwerp:
Maintenance Fluid Therapy

Additional relevant MeSH terms:
Disease
Thoracic Diseases
Water-Electrolyte Imbalance
Pathologic Processes
Respiratory Tract Diseases
Metabolic Diseases