Skip to content

Characterization of the Efficacy of Furosemide Depending on Albumin Function

Characterization of the Efficacy of Furosemide Depending on Albumin Function - a Prospective Monocentric Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04972617
Enrollment
50
Registered
2021-07-22
Start date
2022-05-17
Completion date
2022-10-31
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Critical Illness

Keywords

furosemide, albumin function, albumin

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.

Interventions

DIAGNOSTIC_TESTalbumin 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.

Sponsors

University of Rostock
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the ratio of urine output to fluid input after initiation of furosemide therapy in correlation to the ABiC6 hours post-doseAssessment 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 ABiC5 minutes post-doseAssessment of the patient-specific unbound furosemide fraction 5 minutes after furosemid administration

Secondary

MeasureTime frameDescription
Influence of disease severity on ABiC12 hoursCorrelation 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 ABiC12 hoursCorrelation 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026