Characterization of the Efficacy of Furosemide Depending on Albumin Function

NCT04972617 | Completed

• 1 other identifier: Albumin - Furosemid
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure; Critical Illness

Keywords

furosemide; albumin function; albumin

Outcome Measures

Primary Outcomes (2)

• Change in the ratio of urine output to fluid input after initiation of furosemide therapy in correlation to the ABiC

  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

  6 hours post-dose

• Change of the levels of the patient-specific unbound furosemide fraction in correlation to the ABiC

  Assessment of the patient-specific unbound furosemide fraction 5 minutes after furosemid administration

  5 minutes post-dose

Secondary Outcomes (2)

• Influence of disease severity on ABiC

  12 hours

• Influence of biochemical parameters on ABiC

  12 hours

Study Arms (1)

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.

Diagnostic Test: albumin function analysis (ABIC)

Interventions

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.

Also known as: analysis of total furosemide concentration

observational group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

intensive care patients admitted to University Hospital Rostock

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

University Hospital Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steffen Mitzner, MD, PhD

  University Hospital Rostock

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 22, 2021
• Study Start: May 17, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Locations

DE (1)