TOnicity of Perioperative Maintenance SoluTions

NCT03080831 | Completed Phase 4

• 1 other identifier: 17/4/34
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Maintenance Fluid Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Resuscitation Fluids

  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)

• Vasopressor Use

  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)

• Physiological Mechanisms: Aldosterone level

  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.

• Physiological Mechanisms: Fractional Excretion of Sodium

  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.

• Electrolyte Homeostasis and Disorders: Sodium

  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.

Study Arms (2)

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

ACTIVE COMPARATOR

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

Glucion 5%

ACTIVE COMPARATOR

Drug: Glucion 5%

Interventions

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

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

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.

Glucion 5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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
• Massive perioperative transfusion or intraoperative resuscitation of +2.5L of crystalloids/colloids
• Absence of admission to ICU

Sponsors & Collaborators

• Niels Van Regenmortel: lead

Study Sites (1)

University Hospital, Antwerp

Edegem, 2650, Belgium

Location

Related 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. doi: 10.1016/S0140-6736(02)08711-1.

  PMID: 12044376 BACKGROUND

• 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.

  PMID: 26422725 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Thoracic Diseases; Water-Electrolyte Imbalance; Edema

Interventions

Glucose; Potassium

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study fluids blinded using opaque bags
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: March 15, 2017
• Study Start: March 9, 2017
• Primary Completion: July 15, 2018
• Study Completion: July 15, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

BE (1)