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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne

Cologne, 50937, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: May 30, 2019
Registry last updated: Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed