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Diuretic

Diuretic Therapy for Heart Failure (ESCALATE Trial)

Phase 2
Recruiting
Led By Sean P. Collins, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
IV diuretic ordered or planned to be during first 24 hours of ED or inpatient stay
Emergency Department diagnosis of Acute Heart Failure (AHF)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days from randomization
Awards & highlights

ESCALATE Trial Summary

This trial is testing a new way to give diuretics to people with heart failure in the emergency room, using less medication while still keeping sodium levels low.

Who is the study for?
The ESCALATE trial is for adults over 18 with Acute Heart Failure (AHF) diagnosed in the Emergency Department. They must have symptoms like edema, chest X-ray or ultrasound showing AHF, jugular vein swelling, lung crackles, S3 heart sound, or significant weight gain from fluid. Patients already on IV diuretics may qualify but not if they've had more than two doses before screening.Check my eligibility
What is being tested?
This study tests a new way to use diuretics based on urine sodium levels against usual care in patients with acute heart failure. Participants are randomly assigned to either the test protocol or standard treatment after their initial emergency department evaluation.See study design
What are the potential side effects?
Diuretic therapy can cause dehydration, electrolyte imbalances (like low potassium), kidney function changes and sometimes blood pressure drops. The specific side effects will depend on how each person's body responds to the medication.

ESCALATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled to receive IV diuretics during my first day in the hospital.
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I was diagnosed with Acute Heart Failure in the Emergency Department.
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I am older than 18 years.
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I have symptoms or test results that suggest acute heart failure.
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I have swelling in my legs.

ESCALATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of hospital discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Status Score
Secondary outcome measures
Average daily natriuresis
CV Death and AHF Readmission
Change in natriuretic peptides
+8 more
Other outcome measures
180-day all cause death
Acute Kidney Injury Differences in Epithelial sodium channel (ENaC) levels
CV death or Myocardial Infarction (MI) during hospitalization
+5 more

ESCALATE Trial Design

2Treatment groups
Active Control
Group I: Protocolized spot urine sodium guided diuretic therapyActive Control1 Intervention
Patients will have a spot urine sodium and urine creatinine obtained. The urine and creatinine results will be input into the diuretic calculator and the diuretic dose will be chosen based on daily goals for urine output and net negative fluid balance. Performed 3 times per day, diuretic dosing will be individualized based on the proportion of 24-hour diuresis achieved since the prior IV diuretic dose. Every 24 hours new goals for urine output and net negative fluid balance are established based on the study and treatment team's assessment of residual congestion until protocol completion.
Group II: Guideline-based careActive Control1 Intervention
Patients will be placed on guideline-based diuretic dosing consistent with usual practice. The initial dose will be two times their home dose and will be subsequently adjusted by the treating team based on renal function and symptom severity. The treating team can increase or decrease the frequency and dose of diuretic based on urine output and clinical assessment. Patients in this arm also have urine collected 3 times per day by the bedside nurse to mirror the intervention arm.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
670,594 Total Patients Enrolled
12 Trials studying Heart Failure
4,539 Patients Enrolled for Heart Failure
Sean P. Collins, MDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Protocolized diuretic therapy (Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT04481919 — Phase 2
Heart Failure Research Study Groups: Protocolized spot urine sodium guided diuretic therapy, Guideline-based care
Heart Failure Clinical Trial 2023: Protocolized diuretic therapy Highlights & Side Effects. Trial Name: NCT04481919 — Phase 2
Protocolized diuretic therapy (Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04481919 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this trial?

"Affirmative. According to the information listed on clinicaltrials.gov, this medical trial is currently recruiting patients and was originally posted in May 1st 2022. The study seeks 484 participants from 2 sites as of its last update on 5/23/2022."

Answered by AI

How hazardous is Protocolized spot urine sodium guided diuretic therapy to individuals?

"This Phase 2 trial has provided some evidence of safety, resulting in Protocolized spot urine sodium guided diuretic therapy receiving a score of two. However, there is not yet any data demonstrating efficacy."

Answered by AI

What is the maximum capacity of participants for this investigation?

"Affirmative, the available information on clinicaltrials.gov denotes that this research endeavour is actively seeking participants. It was first published on May 1st 2022 and underwent revisions as recently as 23rd of the same month. At present, 484 candidates are needed at 2 sites for enrolment."

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~273 spots leftby Sep 2026