EdemaNCT03967717
Correlation of Clinical and Laboratory Findings and Diuretic Efficacy in Patients With Edematous States in the Emergency Department
An observational study of Edema, run by University of Cologne at 1 site in Germany.
Trial summary
The aim of the study is the characterization of parameters from medical history, physical examination and diagnostics, which correlate with and could be used to predict diuretic efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema
- What is being tested?
- Characterization of parameters of medical history, examination and diagnostics.
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jun 2019to 4 Apr 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: Inclusion of patients with edematous states of cardiac or renal genesis. Patients with liver cirrhosis and in need of ascites puncture and/or thoracentesis are excluded.
Who may be able to join
- Age over 18 years.
- Edema (peripheral and/or pulmonal) of cardiac or renal genesis.
Who cannot join
- Persons who are in a dependency/employment relationship with the investigators.
- Accommodation in an institution by judicial or administrative order.
- Patients in need of ascites puncture and/or thoracentesis on admission day.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is the characterization of parameters from medical history, physical examination and diagnostics, which correlate with and could be used to predict diuretic efficacy.
Read the detailed description
This prospective observational study is conducted to identify and further isolate possible predictors for the efficacy of diuretics and to identify potential new predictors.
The study also observes if specific diuretic regimes (e.g. combination of loop diuretics and distal effective diuretics for sequential nephron blockade) have a greater diuretic effect. This is not yet proved.
The data of the study shall to help to determine criteria, allowing to choose an effective diuretic regime in different patient cohorts already at the beginning of therapy and to identify patients at high risk.
- Conditions
- Edema
- Being tested
- Characterization of parameters of medical history, examination and diagnostics.
- Keywords
- Edema
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Characterization of parameters of medical history, examination and diagnostics.Other
Patients receive standard of care diuretics. The study only collects data to characterize parameters of medical history, examination and diagnostics.
| Study group | Role | What they receive |
|---|---|---|
| Patients with edematous states | Patients with edematous states receive standard of care diuretic. Receives: Other: Characterization of parameters of medical history, examination and diagnostics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multivariable regression analysis at 6±1 hours
Multivariable regression analysis at 6±1 hours from timepoint of first diuretic administration in the emergency department.
Independent variables: diuretic dose, clinical characteristics, serum creatinine, serum urea, urine sodium, urine conductivity and others. The dependent variable will be urine volume 6±1h after diuretic therapy or the difference in weight before diuretic administration and 6±1 hours afterwards.
Measured: 6±1 hours from timepoint of first diuretic administration in the emergency department
Multivariable regression analysis 24 hours time course
Multivariable regression analysis over 24 hours time course from timepoint of first diuretic administration in the emergency department.
Independent variables: diuretic dose, clinical characteristics, serum creatinine, serum urea, urine sodium, urine conductivity and others. The dependent variable will be urine volume at different timepoints (e.g. 6h, 18h, 24h) within a maximum of 24 hours after first diuretic administration
Measured: 24 hours time course from timepoint of first diuretic administration in the emergency departmentnistration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start28 Jun 2019
- Primary completion18 Mar 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967717
- Sponsor's protocol ID
- Protocol 1.0
- Status last verified
- Nov 2023
- First submitted
- 27 May 2019
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Clinical and Laboratory Findings and Diuretic Efficacy in Patients With Edematous States in the Emergency Department
- ClinicalTrials.gov ID
- NCT03967717
- Acronym / sponsor ID
- Protocol 1.0
- Conditions
- Edema
- Keywords
- Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 30 May 2019 (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.
The aim of the study is the characterization of parameters from medical history, physical examination and diagnostics, which correlate with and could be used to predict diuretic efficacy.
Detailed description
This prospective observational study is conducted to identify and further isolate possible predictors for the efficacy of diuretics and to identify potential new predictors.
The study also observes if specific diuretic regimes (e.g. combination of loop diuretics and distal effective diuretics for sequential nephron blockade) have a greater diuretic effect. This is not yet proved.
The data of the study shall to help to determine criteria, allowing to choose an effective diuretic regime in different patient cohorts already at the beginning of therapy and to identify patients at high risk.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with edematous states | – | Other: Characterization of parameters of medical history, examination and diagnostics.Patients with edematous states receive standard of care diuretic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion of patients with edematous states of cardiac or renal genesis. Patients with liver cirrhosis and in need of ascites puncture and/or thoracentesis are excluded.
Key inclusion criteria (2 listed)
- Age over 18 years.
- Edema (peripheral and/or pulmonal) of cardiac or renal genesis.
Key exclusion criteria (3 listed)
- Persons who are in a dependency/employment relationship with the investigators.
- Accommodation in an institution by judicial or administrative order.
- Patients in need of ascites puncture and/or thoracentesis on admission day.
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 |
|---|---|---|
| Characterization of parameters of medical history, examination and diagnostics.Patients receive standard of care diuretics. The study only collects data to characterize parameters of medical history, examination and diagnostics. | Other | Patients with edematous states |
Primary outcome
Multivariable regression analysis at 6±1 hours
Time frame: 6±1 hours from timepoint of first diuretic administration in the emergency department
Multivariable regression analysis at 6±1 hours from timepoint of first diuretic administration in the emergency department. Independent variables: diuretic dose, clinical characteristics, serum creatinine, serum urea, urine sodium, urine conductivity and others. The dependent variable will be urine volume 6±1h after diuretic therapy or the difference in weight before diuretic administration and 6±1 hours afterwards.
Multivariable regression analysis 24 hours time course
Time frame: 24 hours time course from timepoint of first diuretic administration in the emergency departmentnistration
Multivariable regression analysis over 24 hours time course from timepoint of first diuretic administration in the emergency department. Independent variables: diuretic dose, clinical characteristics, serum creatinine, serum urea, urine sodium, urine conductivity and others. The dependent variable will be urine volume at different timepoints (e.g. 6h, 18h, 24h) within a maximum of 24 hours after first diuretic administration
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 29 Nov 2023.
- 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.
Volker Burst, MD principal investigator
University Hospital of Cologne
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 Edema, run by University of Cologne 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 2 inclusion and 3 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 29 Nov 2023. 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?
Multivariable regression analysis at 6±1 hours (time frame: 6±1 hours from timepoint of first diuretic administration in the emergency department). 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 29 Nov 2023.