Clinical trial NCT04972617: Characterization of the Efficacy of Furosemide Depending on Albumin Function
Official title: Characterization of the Efficacy of Furosemide Depending on Albumin Function - a Prospective Monocentric Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Failure
Critical Illness
Keywords: furosemide
albumin function
albumin
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: intensive care patients admitted to University Hospital 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the ratio of urine output to fluid input after initiation of furosemide therapy in correlation to the ABiC
timeFrame: 6 hours post-dose
measure: Change of the levels of the patient-specific unbound furosemide fraction in correlation to the ABiC
timeFrame: 5 minutes post-dose
Secondary outcomes:
measure: Influence of disease severity on ABiC
timeFrame: 12 hours
measure: Influence of biochemical parameters on ABiC
timeFrame: 12 hours
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University Hospital Rostock
state: Mecklenburg Vorpommern
Study officials:
affiliation: University Hospital Rostock
name: Steffen Mitzner, MD, PhD
role: STUDY_DIRECTOR
References: