Congestive Heart Failure Weight Study

Congestive Heart Failure Clinical Trial

Official title:

Time of Day and Accurate Weights for Patients With Congestive Heart Failure (CHF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185249
• Other study ID #: 10-010
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: June 19, 2013
• Start date: August 2009
• Est. completion date: May 2011

Study information

• Verified date: June 2013
• Source: Central DuPage Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Early morning weights to monitor CHF patient's fluid status is common practice but there is a lack of evidence that this is the best practice. The purpose of this study is to determine if there is a difference in net weight gain or loss for hospitalized patients with CHF who are weighed in the evening instead of early morning.

Description:

This is a quasi-experimental pilot study with prospective cohort design. Study subjects will be weighed in the early morning and then again in the evening for a minimum of three days. Analysis will be accomplished on data by analysis within-subjects data utilizing the paired t test. Other data to be collected includes dates of hospitalization, demographics, dose and timing of medications, lab results and documentation of comorbid conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18-85 years old

• Admitted to hospital with a primary diagnosis of heart failure or fluid overload

• Ambulatory with a medical order to be out of bed

• Able to stand on a scale

• Have no problems with balance

Exclusion Criteria:

• Patients with a primary diagnosis other than heart failure or fluid overload

• Patients diagnosed with renal failure

• Non-English speaking

• Unable to follow directions or consent due to cognitive impairment

• Medical order for bed rest

• Involved in another study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Procedure:
• Weigh subjects on a scale in the standing position
Subjects will stand on a scale in the mornings, and the evenings for 3 days while hospitalized.

Locations

Country	Name	City	State
United States	Central DuPage Hospital	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Central DuPage Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients		Mean differences in the morning (5am) weights compared for three consecutive days. Day 1, Day 2, Day 3. Mean difference in the morning (5am) and evening (8pm) weights for three consecutive days. Day 1, Day 2, Day 3.	No