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Correlation of Clinical and Laboratory Findings and Diuretic Efficacy in Patients With Edematous States in the Emergency Department

Correlation of Clinical and Laboratory Findings and Diuretic Efficacy in Patients With Edematous States in the Emergency Department

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03967717
Enrollment
102
Registered
2019-05-30
Start date
2019-06-28
Completion date
2022-04-04
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edema

Keywords

Edema

Brief 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.

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.

Interventions

OTHERCharacterization 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.

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age over 18 years. * Edema (peripheral and/or pulmonal) of cardiac or renal genesis.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Multivariable regression analysis at 6±1 hours6±1 hours from timepoint of first diuretic administration in the emergency departmentMultivariable 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 course24 hours time course from timepoint of first diuretic administration in the emergency departmentnistrationMultivariable 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026