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NCT Number: NCT04972617

Characterization of the Efficacy of Furosemide Depending on Albumin Function

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

albumin function analysis (ABIC)

Diagnostic Test

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.

Other names: analysis of total furosemide concentration

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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)
  2. 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

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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