ACTIVE_NOT_RECRUITING

Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)

Talk to us

Conditions

Heart FailureAcute Heart FailureDiuretic TherapyEmergency Department

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared to structured usual care in ED patients with AHF. Participants will be recruited following an initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium.

Official Title

A Randomized Trial of Protocolized Diuretic Therapy Compared to Standard Care in Emergency Department Patients With Acute Heart Failure

Quick Facts

Study Start:2022-05-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04481919

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18
  2. * Emergency Department diagnosis of Acute Heart Failure (AHF)
  3. * Any one of the following:
  4. * \> 10 pounds of volume overload physician estimate or historical dry weight
  5. * IV diuretic ordered or planned to be during first 24 hours of ED or inpatient stay
  1. * End Stage Renal Disease (ESRD) requiring dialysis
  2. * Need for immediate intubation
  3. * Acute Coronary Syndrome - presentation consistent with myocardial ischemia AND new ST-Segment elevation/depression
  4. * Temperature \> 100.5ºF
  5. * End Stage Heart Failure: transplant list or ventricular assist device
  6. * Concurrent use of ototoxic medications including intravenous aminoglycosides and cisplatin
  7. * Systolic Blood Pressure \< 90 mmHg at time of consent
  8. * LV outflow obstruction, severe uncorrected stenotic valvular disease or severe restrictive cardiomyopathy
  9. * Greater than 2 doses of IV diuretic administered at the time of screening from the time of the hospital presentation leading to this admission (outside hospital time is included)
  10. * Severe, uncorrected serum electrolyte abnormalities at the time of consent (serum potassium \<3.0 mEq/L, magnesium \<1.0 mEq/L or sodium \<125 or \>150 mEq/l)
  11. * Lack of informed consent

Contacts and Locations

Principal Investigator

Sean P. Collins, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

VA Tennessee Valley Health Service
Nashville, Tennessee, 37232
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Sean P. Collins, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-05-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Diuretic Therapy
  • Emergency Department

Additional Relevant MeSH Terms

  • Heart Failure
  • Acute Heart Failure