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Validation of a Mortality Prediction Model for Acutely Decompensated Heart Failure Patients

NCT00536367 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 226

Last updated 2014-06-12

No results posted yet for this study

Summary

The purpose of this protocol is to determine if the 3 variable mortality prediction model established using data from a retrospective, multi-center patient registry (The ADHERE Acute Decompensated HEart FailuRE National Registry) will hold for a prospective, observational outcome study of OSU patients diagnosed in the Emergency Department (ED)with Acute Decompensated Heart Failure (ADHF). In the retrospective registry, three parameters were found to be highly predictive of inpatient mortality for patients admitted with ADHF - on admission, BUN \> 43 mg/dL, systolic BP \< 115 mmHg, and Cr \> 2.75 mg/dL. However, the very nature of the ADHERE database limited the analytic potential of this model, as the data captured by ADHERE is retrospective and limited to the inpatient stay, and the only outcome evaluated was inpatient mortality. Due to its inherent limitations, the model did not and could not address longer term outcomes, such as repeat visits to the emergency department after discharge, or need for readmission to an acute care setting, which frequently occurs soon after discharge in patients who survive to discharge after being admitted with ADHF.

This observational study will create a registry of patient information obtained from an interview with the patient and a review of the patient's medical record. Follow up information at 30 days post discharge will be obtained by phone interview with the patient and a review of the patient's OSUMC visit history.

Most ED patients diagnosed with ADHF are admitted, as emergency physicians are aware that heart failure in general carries a very high mortality rate. However, as risk stratification for ADHF is a severely under researched area, it is not at all clear which patients with acutely decompensated heart failure will have a poor outcome in the short and intermediate term. With an improved understanding of the risk profile of our ADHF patients, more appropriate decision making and disposition assignment can be made.

Conditions

  • Heart Failure, Congestive

Interventions

OTHER

No intervention - observational study only

Sponsors & Collaborators

  • Emergency Medicine Foundation

    collaborator OTHER

  • Brian Hiestand MD

    lead OTHER

Principal Investigators

  • Brian C Hiestand, MD, MPH · The Ohio State University Dept. of Emergency Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-07-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536367 on ClinicalTrials.gov