Characterization of the Efficacy of Furosemide Depending on Albumin Function

Overview

During this prospective, uncontrolled and non-interventional observational study, the influence of albumin function on the efficacy of furosemide will be investigated. The aim of the study is to provide information on the efficacy of furosemide depending on albumin function.

Full Title of Study: “Characterization of the Efficacy of Furosemide Depending on Albumin Function – a Prospective Monocentric Observational Study”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: October 31, 2022

Detailed Description

In patients with intravenous furosemide administration, an additional 15 ml of blood is taken for the analysis of specific parameters as part of the blood sampling necessary for the treatment of the patient. The effect of furosemide is assessed on the basis of the patient's urine excretion. For this purpose, fluid intake and excretion are balanced over 6 hours. The blood sample is taken at the beginning of the balancing period. In addition, the albumin concentration, ABiC, as well as the total and free concentration of furosemide in the collected urine are determined.

Interventions

• Diagnostic Test: albumin function analysis (ABIC)
  • After centrifugation (10 minutes at 4000 rpm), the plasma is aliquoted and stored at minus 80° C until further analysis. The free as well as the total furosemide concentration is determined by HPLC. In addition to the characterisation of the albumin function by means of the ABiC, these samples can also be used for the determination of the albumin concentration (prerequisite for the determination of the ABiC) and free furosemide concentration as well as for the determination of further parameters relevant for the albumin function.

Arms, Groups and Cohorts

• observational group
  • In patients with intravenous furosemide administration, an additional 15 ml of blood is taken for the analysis of specific parameters as part of the blood sampling necessary for the treatment of the patient. The effect of furosemide is assessed on the basis of the patient’s urine excretion. For this purpose, fluid intake and excretion are balanced over 6 hours. The blood sample is taken at the beginning of the balancing period. In addition, the albumin concentration, ABiC, as well as the total and free concentration of furosemide in the collected urine are determined.

Clinical Trial Outcome Measures

Primary Measures

• Change in the ratio of urine output to fluid input after initiation of furosemide therapy in correlation to the ABiC
  • Time Frame: 6 hours post-dose
  • Assessment of the ABiC 5 minutes after furosemid administration as well as urine output and fluid input for 6 hours post-dose for every hour
• Change of the levels of the patient-specific unbound furosemide fraction in correlation to the ABiC
  • Time Frame: 5 minutes post-dose
  • Assessment of the patient-specific unbound furosemide fraction 5 minutes after furosemid administration

Secondary Measures

• Influence of disease severity on ABiC
  • Time Frame: 12 hours
  • Correlation of clinical parameters of critical ill patients with the ABiC: Comorbidities of the organ subsystems (cardio-pulmonary, abdominal, nephrological, endocrinological) Drug intake Conditions affecting critically ill patients (haemodynamic status, sepsis, ARDS, nutritional status)
• Influence of biochemical parameters on ABiC
  • Time Frame: 12 hours
  • Correlation of biochemical parameters of critical ill patients with the ABiC: Hemogram Acid-base balance Organ-specific parameters (kidney, liver, immune system) Albumin Unbound forusemide fraction Urine analysis

Participating in This Clinical Trial

Inclusion Criteria

• Informed consent – Attending intensive care physician intends to prescribe IV furosemide to increase urine output – Arterial (central venous if applicable) and urinary catheter in situ Exclusion Criteria:

• Attending intensive care physician intends to prescribe further doses of diuretic medication (including furosemide infusion) within the 6 hours required for fluid collection – Patients who received intravenous or oral diuretics (including mannitol) in the 6 hours prior to study enrolment – Patients who have received other medications (e.g. fludrocortisone) known to affect renal sodium or water excretion in the 24 hours prior to study entry – Patients with uncontrolled hyperglycaemia (plasma glucose >10mmol/L). – Patients who were receiving renal replacement therapy prior to the start of the study – Patients with obstructive uropathy, macroscopic haematuria or intra-abdominal hypertension (>20mmHg) – Age < 18 years

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Rostock
• Provider of Information About this Clinical Study
  • Principal Investigator: Gerd Klinkmann, Principal Investigator – University of Rostock
• Overall Official(s)
  • Steffen Mitzner, MD, PhD, Study Director, University Hospital Rostock