Acute Renal FailureNCT04972617
Characterization of the Efficacy of Furosemide Depending on Albumin Function
An observational study of Acute Renal Failure and Critical Illness, run by University of Rostock at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure, Critical Illness
- What is being tested?
- albumin function analysis (ABIC)
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 17 May 2022to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: intensive care patients admitted to University Hospital Rostock
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Rostock
Rostock, Mecklenburg-Vorpommern, 18057
About this study
Official title: Characterization of the Efficacy of Furosemide Depending on Albumin Function - a Prospective Monocentric Observational Study
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.
Read the detailed 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.
- Conditions
- Acute Renal Failure, Critical Illness
- Being tested
- albumin function analysis (ABIC)
- Keywords
- furosemide, albumin function, albumin
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albumin function analysis (ABIC)Diagnostic test
Also called analysis of total furosemide concentration
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: albumin function analysis (ABIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 minutes post-dose
Secondary outcomes (2)
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)
Measured: 12 hours
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
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start17 May 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerd Klinkmann, University of Rostock
- Investigators
- Steffen Mitzner, MD, PhD, Study director, University Hospital Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972617
- Sponsor's protocol ID
- Albumin - Furosemid
- Status last verified
- Oct 2022
- First submitted
- 1 Jul 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Efficacy of Furosemide Depending on Albumin Function - a Prospective Monocentric Observational Study
- ClinicalTrials.gov ID
- NCT04972617
- Acronym / sponsor ID
- Albumin - Furosemid
- Conditions
- Acute Renal Failure, Critical Illness
- Keywords
- furosemide, albumin function, albumin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational group | – | Diagnostic Test: albumin function analysis (ABIC)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intensive care patients admitted to University Hospital Rostock
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albumin function analysis (ABIC)Also: analysis of total furosemide concentrationAfter 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. | Diagnostic test | observational group |
Primary outcome
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
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
2 secondary outcomes
Influence of disease severity on ABiC
Time frame: 12 hours
Influence of biochemical parameters on ABiC
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Mitzner, MD, PhD study director
University Hospital Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure and Critical Illness, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.