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Clinical Trials/NCT04972617
NCT04972617CompletedNot Applicable

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

University of Rostock1 site in 1 country50 target enrollmentStarted: May 17, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Change of the levels of the patient-specific unbound furosemide fraction in correlation to the ABiC

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Influence of disease severity on ABiC(12 hours)
  • Influence of biochemical parameters on ABiC(12 hours)

Investigators

Sponsor
University of Rostock
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gerd Klinkmann

Principal Investigator

University of Rostock

Study Sites (1)

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