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Diuretic Efficacy of Dexamethasone in Heart Failure

Primary Purpose

Heart Failure, Congestive

Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
dexamethasone
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring dexamethasone, diuretic, congestive heart failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kunshen Liu
  • The First Hospital of Hebei Medical University

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 7, 2005
Last Updated
July 2, 2008
Sponsor
Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00263302
Brief Title
Diuretic Efficacy of Dexamethasone in Heart Failure
Official Title
Diuretic Efficacy of Dexamethasone in Congestive Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2005
Overall Recruitment Status
Suspended
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hebei Medical University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
dexamethasone, diuretic, congestive heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dexamethasone
Primary Outcome Measure Information:
Title
urine volume
Title
urine electrolyte excretion (urine sodium, urine potassium, urine chloride), and urine creatinine.
Title
serum electrolyte (serum sodium, serum potassium, serum chloride), serum creatinine, serum urea, serum uric Acid.
Title
fractional sodium excretion
Title
glomerular filtration rate (calculated by Cockroft and Gault formula).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunshen Liu, M.D.
Organizational Affiliation
Hebei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Kunshen Liu
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050031
Country
China
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050031
Country
China

12. IPD Sharing Statement

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Diuretic Efficacy of Dexamethasone in Heart Failure

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