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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03967717
Other study ID # Protocol 1.0
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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