Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

Healthy Adult Volunteers Clinical Trial

— MIHMoSA  

Official title:

Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults, a Single-Blind Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822898
• Other study ID #: 16/15/175
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2016
• Last updated: August 7, 2016
• Start date: June 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy adults, 18-70 years of age

• BMI 17-45 kg/m².

• Creatinine clearance >60 ml/min (according to eGFR CKD-EPI formula).

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy Adult Volunteers

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital, Antwerp	Edegem

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Baxter Healthcare Corporation

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
Other	Osmoregulatory Profile 1: urinary volume (mL)	Sequential changes in mean urinary volume (per fluid type) at T0-T12-T24-T36-T48.	48h	No
Other	Osmoregulatory Profile 2: urinary osmolality (mOsm/kg)	Sequential changes in mean urinary osmolality (per fluid type). Urinary osmolality is determined on a sample of every individual diuresis. Subjects urinate as the urge rises.	48h	No
Other	Osmoregulatory Profile 3: serum antidiuretic hormone (ADH) (pg/mL)	Sequential changes in mean serum ADH (per fluid type) at T0-T24-T48.	48h	No
Other	Osmoregulatory Profile 4: thirst score (scale 0-5)	Sequential changes in mean thirst score (per fluid type) at T0-T12-T24-T36-T48. The thirst score is a subjective score on a scale of 0-5.	48h	No
Other	Volume Regulatory Profile 1: urinary sodium (mmol/L)	Sequential changes in mean urinary sodium (per fluid type). Urinary sodium is determined on a sample of every individual diuresis. Subjects urinate as the urge rises. Urinary sodium is used to calculate the fractional excretion of sodium.	48h	No
Other	Volume Regulatory Profile 2: serum aldosterone (ng/dL)	Sequential changes in mean serum aldosterone (per fluid type) at T0-T24-T48.	48h	No
Other	Volume Regulatory Profile 3: urinary potassium (mmol/L)	Sequential changes in mean urinary potassium (per fluid type). Urinary potassium is determined on a sample of every individual diuresis. Subjects urinate as the urge rises.	48h	No
Other	Acid-Base Profile 1: serum chloride (mmol/L)	Sequential changes in mean serum chloride (per fluid type) at T0-T12-T24-T36-T48.	48h	No
Other	Acid-Base Profile 2: serum apparent strong ion difference (mEq/L)	Sequential changes in mean serum apparent strong ion difference (per fluid type) at T0-T12-T24-T36-T48.	48h	No
Other	Acid-Base Profile 3: urinary anion gap (mmol/L)	Sequential changes in mean urinary anion gap (per fluid type). Urinary potassium is determined on a sample of every individual diuresis. Subjects urinate as the urge rises.	48h	No
Other	Other Electrolytes Profile 1: Serum phosphate (mmol/L)	Sequential changes in mean serum phosphate (per fluid type) at T0-T24-T48.	48h	No
Other	Other Electrolytes Profile 2: Red blood cell magnesium (mmol/L)	Sequential changes in mean red blood cell magnesium (per fluid type) at T0-T24-T48.	48h	No
Other	Cortisol (µg/dL)	Serum cortisol as a measure of stress due to fasting.	48h	No
Other	Bioelectrical impedance analysis 1: Total body water	Sequential changes in mean total body water (per fluid type) at T0-T24-T48.	48h	No
Other	Bioelectrical impedance analysis : Extracellular volume	Sequential changes in mean extracellular volume (per fluid type) at T0-T24-T48.	48h	No
Primary	Urine Output	Urinary output over study period (as AUC).	48h	No
Primary	Body weight	Body weight over study period (as AUC), used as a back up parameter for urinary output.	48h	No
Secondary	Amount of sodium retention / excretion (excreted sodium / administered sodium)	Sodium retention / excretion over study period (mean at 24 and 48h)	48h	No
Secondary	Number of episodes of hypokalemia (<3.5 mmol/L), hyponatremia (<135 mmol/L), hypernatremia (>145 mmol/L)		48h	Yes
Secondary	Change of sodium level from its baseline value.	Area under the electrolyte concentration curve (baseline level is reference line)	48h	No
Secondary	Change of sodium and potassium level from its baseline value.	Area under the electrolyte concentration curve (baseline level is reference line)	48h	No

External Links

•   GIFTASUP guidelines