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Thoracic DiseasesPhase 4TOPMAST-1NCT03080831

TOnicity of Perioperative Maintenance SoluTions

A Phase 4 study testing NaCl 0.9% in Glucose 5% + 40mmol/L Potassium and Glucion 5% in people with Thoracic Diseases and Water-Electrolyte Imbalance, run by Niels Van Regenmortel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NaCl 0.9% in Glucose 5% + 40mmol/L Potassium and Glucion 5%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteBelgium
Study dates
9 Mar 2017to 15 Jul 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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))

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital, Antwerp

    Edegem, 2650

Other trials in Belgium

About this study

Official title: TOnicity of Perioperative Maintenance SoluTions - Part 1: Thoracic Surgery

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.

Being tested
NaCl 0.9% in Glucose 5% + 40mmol/L Potassium, Glucion 5%
Keywords
Maintenance Fluid Therapy
Medical subject headings
Thoracic Diseases, Water-Electrolyte Imbalance, Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NaCl 0.9% in Glucose 5% + 40mmol/L PotassiumDrug

    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%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.

Study groups in NCT03080831
Study groupRoleWhat they receive
NaCl 0.9% in Glucose 5% + 40mmol/L PotassiumActive comparatorNot described
Receives: Drug: NaCl 0.9% in Glucose 5% + 40mmol/L Potassium
Glucion 5%Active comparatorNot described
Receives: Drug: Glucion 5%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fluid balance

    Difference between all fluid intake and output

    Measured: 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 (14)

  1. Resuscitation Fluids

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

    Measured: 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)

  2. Vasopressor Use

    The cumulative amount of vasopressors during the study period

    Measured: 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)

  3. Physiological Mechanisms: Aldosterone level

    Change from baseline aldosterone level at start of surgery

    Measured: 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.

  4. Physiological Mechanisms: Fractional Excretion of Sodium

    Change from baseline FeNa at start of surgery

    Measured: 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.

  5. Electrolyte Homeostasis and Disorders: Sodium

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

    Measured: 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.

  6. Electrolyte Homeostasis and Disorders: Potassium

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

    Measured: 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.

  7. Electrolyte Homeostasis and Disorders: Chloride

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

    Measured: 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.

  8. Electrolyte Homeostasis and Disorders: Strong Ion Difference

    Mean SID level and change from baseline.

    Measured: 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.

  9. Electrolyte Homeostasis and Disorders: Phosphate

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

    Measured: 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.

  10. Electrolyte Homeostasis and Disorders: Calcium

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

    Measured: 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.

  11. Clinical Endpoints: paO2/FiO2

    Mean postoperative paO2/FiO2

    Measured: 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.

  12. Clinical Endpoints: occurrence of de novo atrial fibrillation

    occurrence of de novo atrial fibrillation (Y/N)

    Measured: 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.

  13. Clinical Endpoints: occurrence of acute kidney injury (AKI)

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

    Measured: 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.

  14. Sodium balance

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

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2017
  2. Study start9 Mar 2017
  3. Primary completion15 Jul 2018
  4. Study completion15 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080831
Sponsor's protocol ID
17/4/34
Acronym
TOPMAST-1
Status last verified
Aug 2018
First submitted
19 Feb 2017
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Anonymized data available on reasonable request

Publications

  • 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.

    PubMed 12044376

  • 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.

    PubMed 26422725

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NaCl 0.9% in Glucose 5% + 40mmol/L Potassium and Glucion 5% in people with Thoracic Diseases and Water-Electrolyte Imbalance, run by Niels Van Regenmortel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03080831, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.

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