Diuretic Efficacy of Dexamethasone in Heart Failure

Phase 1

Suspended

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00263302
• Lead Sponsor: Hebei Medical University

Brief Summary

The purpose of this study is to determine whether glucocorticoids have potent diuretic effects in patients with congestive heart failure.

Detailed Description

Glucocorticoids are known to have pronounced physiological effects in the kidney. Conventional teaching dictates that it should be used with caution in patients with congestive heart failure due to its fluid and sodium retention effects. Surprisingly, despite the widespread prevalence of this belief within the medical community, there are few data to support it. In fact, several small animal studies have documented its striking diuretic effects due to increased renal plasma flow and glomerular filtration rate without changes in the glomerular filtration fraction. We design this study to determine whether glucocorticoids have a potent diuretic effect in patients with heart failure.

Study Timeline

• Status Verified: 2005-01
• Study First Submitted: 2005-12-07
• Study First Submitted QC: 2005-12-07
• Study First Posted: 2005-12-08
• Study Start: 2006-03
• Study Completion: 2006-12
• Last Update Submitted: 2008-07-02
• Last Update Posted: 2008-07-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Congestive heart failure patients due to any cause
• Patients with normal cortical function
• Congestive heart failure patients who are on diuretic therapy
• Clinically stable and body weight maintained the same for at least 3 days without signs of fluid retention

Exclusion Criteria

• Patient refusal
• Signs of infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
urine volume
urine electrolyte excretion (urine sodium, urine potassium, urine chloride), and urine creatinine.
serum electrolyte (serum sodium, serum potassium, serum chloride), serum creatinine, serum urea, serum uric Acid.
fractional sodium excretion
glomerular filtration rate (calculated by Cockroft and Gault formula).

Trial Locations

Locations (2)

Kunshen Liu; 🇨🇳 Shijiazhuang, Hebei, China

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China