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

NCT03967717 | Completed

• 1 other identifier: Protocol 1.0
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema

Keywords

Edema

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Patients with edematous states

Patients with edematous states receive standard of care diuretic.

Other: Characterization of parameters of medical history, examination and diagnostics.

Interventions

Characterization of parameters of medical history, examination and diagnostics. OTHER

Patients receive standard of care diuretics. The study only collects data to characterize parameters of medical history, examination and diagnostics.

Patients with edematous states

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age over 18 years.
• Edema (peripheral and/or pulmonal) of cardiac or renal genesis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Edema

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Volker Burst, MD

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: June 28, 2019
• Primary Completion: March 18, 2022
• Study Completion: April 4, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

DE (1)