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Congestive Heart Failure Weight Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01185249
Recruitment Status : Completed
First Posted : August 19, 2010
Results First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Congestive Heart Failure Procedure: Weigh subjects on a scale in the standing position

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Time of Day and Accurate Weights for Patients With Congestive Heart Failure (CHF)
Study Start Date : August 2009
Primary Completion Date : May 2010
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Body weight taken in a standing position
Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study 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.


Outcome Measures

Primary Outcome Measures :
  1. The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients [ Time Frame: 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185249


Locations
United States, Illinois
Central DuPage Hospital
Winfield, Illinois, United States, 60190
Sponsors and Collaborators
Central DuPage Hospital
Investigators
Principal Investigator: Alice M Siehoff, DNP, RN-BC Central DuPage Hospital
More Information

Responsible Party: Central DuPage Hospital
ClinicalTrials.gov Identifier: NCT01185249     History of Changes
Other Study ID Numbers: 10-010
First Posted: August 19, 2010    Key Record Dates
Results First Posted: July 25, 2013
Last Update Posted: July 25, 2013
Last Verified: June 2013

Keywords provided by Central DuPage Hospital:
CHF
congestive heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases