Characterization of the Efficacy of Furosemide Depending on Albumin Function

NCT ID: NCT04972617

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-17

Study Completion Date

2022-10-31

Brief Summary

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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

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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.

Conditions

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Acute Renal Failure Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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observational group

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.

albumin function analysis (ABIC)

Intervention Type 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.

Interventions

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albumin 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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analysis of total furosemide concentration

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rostock

OTHER

Sponsor Role lead

Responsible Party

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Gerd Klinkmann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steffen Mitzner, MD, PhD

Role: STUDY_DIRECTOR

University Hospital Rostock

Locations

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University Hospital Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Other Identifiers

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Albumin - Furosemid

Identifier Type: -

Identifier Source: org_study_id

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