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

Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967717
• Other study ID #: Protocol 1.0
• Status: Completed
• Start date: June 28, 2019
• Est. completion date: April 4, 2022

Study information

• Verified date: November 2023
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 4, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Emergencies

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6±1 hours from timepoint of first diuretic administration in the emergency department
Primary	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	24 hours time course from timepoint of first diuretic administration in the emergency departmentnistration