Critical Illness Clinical Trial
Official title:
Characterization of the Efficacy of Furosemide Depending on Albumin Function - a Prospective Monocentric Observational Study
Verified date | October 2022 |
Source | University of Rostock |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Rostock | Rostock | Mecklenburg Vorpommern |
Lead Sponsor | Collaborator |
---|---|
University of Rostock |
Germany,
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 |
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