TOnicity of Perioperative Maintenance SoluTions

Fluid Overload Clinical Trial

— TOPMAST-1  

Official title:

TOnicity of Perioperative Maintenance SoluTions - Part 1: Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080831
• Other study ID #: 17/4/34
• Status: Completed
• Phase: Phase 4
• Start date: March 9, 2017
• Est. completion date: July 15, 2018

Study information

• Verified date: August 2018
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	University Hospital, Antwerp	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Niels Van Regenmortel

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid balance	Difference between all fluid intake and output	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	Resuscitation Fluids	The cumulative amount of additional (resuscitation) fluids during the study period	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	Vasopressor Use	The cumulative amount of vasopressors during the study period	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	Physiological Mechanisms: Aldosterone level	Change from baseline aldosterone level at start of surgery	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.
Secondary	Physiological Mechanisms: Fractional Excretion of Sodium	Change from baseline FeNa at start of surgery	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.
Secondary	Electrolyte Homeostasis and Disorders: Sodium	Mean sodium level and change from baseline. Occurrence of hypo and hypernatremia.	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.
Secondary	Electrolyte Homeostasis and Disorders: Potassium	Mean potassium level and change from baseline. Occurrence of hypo and hyperpotassemia.	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.
Secondary	Electrolyte Homeostasis and Disorders: Chloride	Mean chloride level and change from baseline. Occurrence of hypo and hyperchloremia.	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.
Secondary	Electrolyte Homeostasis and Disorders: Strong Ion Difference	Mean SID level and change from baseline.	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.
Secondary	Electrolyte Homeostasis and Disorders: Phosphate	Mean phosphate level and change from baseline. Occurrence of hypo and hyperphosphatemia.	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.
Secondary	Electrolyte Homeostasis and Disorders: Calcium	Mean calcium level and change from baseline. Occurrence of hypo and hypercalcemia.	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.
Secondary	Clinical Endpoints: paO2/FiO2	Mean postoperative paO2/FiO2	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.
Secondary	Clinical Endpoints: occurrence of de novo atrial fibrillation	occurrence of de novo atrial fibrillation (Y/N)	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.
Secondary	Clinical Endpoints: occurrence of acute kidney injury (AKI)	AKI according to RIFLE-score creatinine and urine R-I-F)	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.
Secondary	Sodium balance	Sodium balance (total in vs out) at end of study, assessed by urine collection.	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).

External Links

•   GIFTASUP guidelines
•   NICE guideline on Intravenous Fluid Therapy in Adults in Hospital