Characterization of the Efficacy of Furosemide Depending on Albumin Function

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04972617
• Other study ID #: Albumin - Furosemid
• Status: Completed
• Start date: May 17, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2022
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Critical Illness

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Rostock	Rostock	Mecklenburg Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Influence of disease severity on ABiC	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)	12 hours
Secondary	Influence of biochemical parameters on ABiC	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	12 hours