Characterization of the Efficacy of Furosemide Depending on Albumin Function

Completed

• Conditions: Critical Illness; Acute Renal Failure
• Interventions: Diagnostic Test: albumin function analysis (ABIC)

• Registration Number: NCT04972617
• Lead Sponsor: University of Rostock

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-22
• Study Start: 2022-05-17
• Status Verified: 2022-10
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observational group	albumin function analysis (ABIC)	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.

Primary Outcome Measures

Name	Time	Method
Change of the levels of the patient-specific unbound furosemide fraction in correlation to the ABiC	5 minutes post-dose	Assessment of the patient-specific unbound furosemide fraction 5 minutes after furosemid administration
Change in the ratio of urine output to fluid input after initiation of furosemide therapy in correlation to the ABiC	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

Secondary Outcome Measures

Name	Time	Method
Influence of disease severity on ABiC	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	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

Trial Locations

Locations (1)

University Hospital Rostock; 🇩🇪 Rostock, Mecklenburg Vorpommern, Germany