Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

NCT02822898 | Completed Phase 4

• 1 other identifier: 16/15/175
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The prescription of intravenous maintenance solutions - although widespread - lacks important data on the optimal sodium and potassium content, which has given rise to an important debate in the scientific literature. Our study compares two different infusion fluids in 12 healthy adult volunteers without renal failure in a single-blind randomized crossover design over two 48 hour periods during which subjects are not allowed to eat or drink. Fluid 1 is a premixed solution containing 54 mmol/L of sodium and 26 mmol/L of potassium; fluid 2 is sodium chloride 0.9% in glucose 5% with 40 mmol/L of potassium. Both solutions are administered at 25 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, clinical parameters and bioelectrical impedance analysis.

Conditions

Healthy Adult Volunteers

Keywords

Maintenance; Intravenous solutions; Intravenous fluids; Tonicity; Potassium; Sodium; Fluid retention

Outcome Measures

Primary Outcomes (2)

• Urine Output

  Urinary output over study period (as AUC).

  48h

• Body weight

  Body weight over study period (as AUC), used as a back up parameter for urinary output.

  48h

Secondary Outcomes (4)

• Amount of sodium retention / excretion (excreted sodium / administered sodium)

  48h

• Number of episodes of hypokalemia (<3.5 mmol/L), hyponatremia (<135 mmol/L), hypernatremia (>145 mmol/L)

  48h

• Change of sodium level from its baseline value.

  48h

• Change of sodium and potassium level from its baseline value.

  48h

Other Outcomes (15)

• Osmoregulatory Profile 1: urinary volume (mL)

  48h

• Osmoregulatory Profile 2: urinary osmolality (mOsm/kg)

  48h

• Osmoregulatory Profile 3: serum antidiuretic hormone (ADH) (pg/mL)

  48h

Study Arms (2)

Isotonic Maintenance Fluid

ACTIVE COMPARATOR

Isotonic Maintenance Fluid

Drug: NaCl 0.9% in Glucose 5% with 40mEq Potassium

Hypotonic Maintenance Fluid

ACTIVE COMPARATOR

Hypotonic Maintenance Fluid

Drug: Glucion 5%

Interventions

NaCl 0.9% in Glucose 5% with 40mEq Potassium DRUG

NaCl 0.9% in Glucose 5% with 40mEq Potassium, administered at 25 mL/kg IBW/h for 48h

Isotonic Maintenance Fluid

Glucion 5% DRUG

Glucion 5% (premixed solution containing 54 mmol/L sodium and 26 mmol/L potassium amongst others), administered at 25 mL/kg IBW/h for 48h

Hypotonic Maintenance Fluid

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults, 18-70 years of age
• BMI 17-45 kg/m².
• Creatinine clearance \>60 ml/min (according to eGFR CKD-EPI formula).

You may not qualify if:

• Acute medical illness within 3 weeks of first study period
• Chronic medication: under diuretic therapy or other chronic medication that interfere with urine output or induce urine retention. All chronic medication should be declared before being enrolled in the study.
• Medical history:
• cardiac failure,
• malnourishment,
• diabetes mellitus,
• urological disease preventing spontaneous or complete emptying of the bladder,
• any medical or non-medical issue preventing complaint-free fasting for 48 hours (e.g. active peptic ulcer, psychosis, substance abuse…)
• Pregnancy

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

University Hospital, Antwerp

Edegem, 2650, Belgium

Location

Related Publications (3)

• 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

• Van Regenmortel N, De Weerdt T, Van Craenenbroeck AH, Roelant E, Verbrugghe W, Dams K, Malbrain MLNG, Van den Wyngaert T, Jorens PG. Effect of isotonic versus hypotonic maintenance fluid therapy on urine output, fluid balance, and electrolyte homeostasis: a crossover study in fasting adult volunteers. Br J Anaesth. 2017 Jun 1;118(6):892-900. doi: 10.1093/bja/aex118.

  PMID: 28520883 DERIVED

Related Links

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

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Niels Van Regenmortel, M.D.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 6, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

BE (1)