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Clinical Trials/NCT03967717
NCT03967717
Completed
Not Applicable

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

University of Cologne1 site in 1 country102 target enrollmentJune 28, 2019
ConditionsEdema

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Edema
Sponsor
University of Cologne
Enrollment
102
Locations
1
Primary Endpoint
Multivariable regression analysis at 6±1 hours
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 28, 2019
End Date
April 4, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Volker Burst

Principal Investigator

University of Cologne

Eligibility Criteria

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.

Outcomes

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

Study Sites (1)

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