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

Completed

• Conditions: Edema
• Interventions: Other: Characterization of parameters of medical history, examination and diagnostics.

• Registration Number: NCT03967717
• Lead Sponsor: University of Cologne

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.

Study Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Study Start: 2019-06-28
• Primary Completion: 2022-03-18
• Study Completion: 2022-04-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with edematous states	Characterization of parameters of medical history, examination and diagnostics.	Patients with edematous states receive standard of care diuretic.

Primary Outcome Measures

Name	Time	Method
Multivariable regression analysis at 6±1 hours	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	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

Trial Locations

Locations (1)

University Hospital of Cologne; 🇩🇪 Cologne, Germany