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

November 28, 2023 updated by: Volker Burst, University of Cologne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50937
        • University Hospital of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with edematous states
Patients with edematous states receive standard of care diuretic.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6±1 hours from timepoint of first diuretic administration in the emergency department
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
24 hours time course from timepoint of first diuretic administration in the emergency departmentnistration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Volker Burst, MD, University Hospital of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2019

Primary Completion (Actual)

March 18, 2022

Study Completion (Actual)

April 4, 2022

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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