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

Sponsor
University of Cologne (Other)
Overall Status
Recruiting
CT.gov ID
NCT03967717
Collaborator
(none)
200
1
54.1
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Characterization of parameters of medical history, examination and diagnostics.

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Correlation of Clinical and Laboratory Findings and Diuretic Efficacy in Patients With Edematous States in the Emergency Department
Actual Study Start Date :
Jun 28, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Multivariate regression analysis 24 hours [From admission to the emergency department until 24 hours after the first diuretic administration]

    Multivariate regression analysis with independent variables, such as sequential nephron blockade, serum creatinine, serum urea, urine sodium. The dependent variable will be the difference in weight before diuretic administration and 24 hours afterwards

  2. Multivariate regression analysis 24 hours time course [From admission to the emergency department until 24 hours after first diuretic administration]

    Multivariate regression analysis with independent variables, such as sequential nephron blockade, serum creatinine, serum urea, urine sodium. The dependent variables will be the difference in weight before and after diuretic administration at different times (e.g. 6h, 18h) within in the first 24 hours after first diuretic administration

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Cologne Cologne Germany 50937

Sponsors and Collaborators

  • University of Cologne

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Volker Burst, Principal Investigator, University of Cologne
ClinicalTrials.gov Identifier:
NCT03967717
Other Study ID Numbers:
  • Protocol 1.0
First Posted:
May 30, 2019
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Volker Burst, Principal Investigator, University of Cologne
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022