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

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.

Conditions

Heart Failure, Acute Heart Failure

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Nashville

VA Tennessee Valley Health Service, Nashville, Tennessee, United States, 37232

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age \> 18
  • * Emergency Department diagnosis of Acute Heart Failure (AHF)
  • * Any one of the following:
  • * \> 10 pounds of volume overload physician estimate or historical dry weight
  • * IV diuretic ordered or planned to be during first 24 hours of ED or inpatient stay
  • * End Stage Renal Disease (ESRD) requiring dialysis
  • * Need for immediate intubation
  • * Acute Coronary Syndrome - presentation consistent with myocardial ischemia AND new ST-Segment elevation/depression
  • * Temperature \> 100.5ºF
  • * End Stage Heart Failure: transplant list or ventricular assist device
  • * Concurrent use of ototoxic medications including intravenous aminoglycosides and cisplatin
  • * Systolic Blood Pressure \< 90 mmHg at time of consent
  • * LV outflow obstruction, severe uncorrected stenotic valvular disease or severe restrictive cardiomyopathy
  • * 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)
  • * 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)
  • * Lack of informed consent

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

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

Study Record Dates

2026-12-31