Assessment of the Effects of Cardiopulmonary Phenotype on Oral and intravenous (IV) Frusemide Pharmacokinetics
An investigation of the change in concentration time profile for the diuretic drug frusemide when administered orally and intravenously to individuals with oedema associated with pulmonary hypertension or compensated and decompensated congestive heart failure.
Flinders University
20 participants
May 5, 2014
Interventional
Conditions
Summary
While there is currently a paucity of evidence to guide this practice, frusemide is routinely administered IV to patients presenting to Flinders Medical Centre (FMC) with either decompensated heart failure or pulmonary hypertension on the basis that expert opinion considers oral frusemide ineffective for managing these conditions. This study will assess the impact of congestive cardiac failure (acutely decompensated and compensated) and pulmonary hypertension on the oral and intravenous (IV) pharmacokinetics of frusemide, and determine whether altered pharmacokinetics may explain the variability and perceived lack of efficacy of oral frusemide in managing these conditions. It is hypothesised that these conditions will differentially affect the rate of oral frusemide absorption (i.e. the time to maximal concentration / response will be delayed), but that neither will affect the extent of absorption (i.e. bioavailability will remain unchanged). By improving the understanding of the impact of these conditions on frusemide pharmacokinetics, this study will form a framework to facilitate future research here at FMC to deliver more personalised and optimised dosing of frusemide that may combine oral and IV routes of administration, which will provide more effective management of symptoms, while reducing the time to hospital discharge.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
On Day 1, in patients that are clinically considered be suffering from oedema secondary to acutely decompensated congestive heart failure or pulmonary hypertension, following the administration of an IV bolus dose of frusemide (typically 40mg), a series of blood (5mL) and urine samples will be collected at t= 0, 1, 2, 3, 4, 5 and 6hrs for analysis of frusemide concentrations. On Day 2 (acutely decompensated phase) following the administration of an oral bolus dose of frusemide (double the Day 1 IV dose; typically 80mg), a series of blood (5mL) and urine samples will be collected at t= 0, 1, 2, 3, 4, 5 and 6hrs for analysis of frusemide concentrations. In patients presenting with oedema secondary to acutely decompensated heart failure, five to seven days later, on Day E-1 when the patient is clinically considered to no longer be acutely decompensated (i.e. they have returned to compensated heart failure) following the administration of an IV bolus dose of frusemide (typically 40mg), a series of blood (5mL) and urine samples will be collected at t= 0, 1, 2, 3, 4, 5 and 6hrs for analysis of frusemide concentrations. On Day E (compensated phase) following the administration of an oral bolus dose of frusemide (double the Day E-1 IV dose; typically 80mg), a series of blood (5mL) and urine samples will be collected at t= 0, 1, 2, 3, 4, 5 and 6hrs for analysis of frusemide concentrations.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12614000461695