Protocolized diuretic therapy
DrugThe urine sodium, urine creatinine and serum 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.
NCT Number: NCT04481919
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.
This study is active but is not currently recruiting participants.
Notify Me19 year and older
All sexes
Interventional
Phase 2
VA Tennessee Valley Health Service, Nashville, Tennessee, United States
A standardized protocol driven treatment pathway for hospitalized patients started in the first few hours of ED evaluation and utilizing objective measures of diuretic response is needed. The investigators believe this would maximize diuretic efficiency, facilitate quicker resolution of congestion, avoid WHF and prolonged LOS, and reduce AHF readmissions. Propr data suggests low urine sodium predicts length of stay and outcomes after initial diuretic dosing in the outpatient and inpatient setting. Further, use of our pathway using spot urine sodium to titrate subsequent loop diuretic doses and maximize response in inpatients with AHF has shown compelling improvements in congestion and weight loss. However, a randomized trial is necessary to determine if initiating this protocol ,started in the ED, will improve AHF outcomes relative to structured usual care. Specifically, the investigators hypothesize use of spot urine sodium guided diuretic therapy will result in significant improvement in days of benefit over the 14 days after randomization. Days of benefit combines patient symptoms captured by global clinical status with clinical state quantifying the need for hospitalization and IV diuresis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
i. Chest radiograph or lung ultrasound consistent with AHF ii. Jugular venous distension iii. Pulmonary rales on auscultation iv. Lower extremity edema v. S3 gallop
Exclusion criteria
The urine sodium, urine creatinine and serum 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.
Time frame: From the time of randomization through day 14
Daily composite of the clinical state and global clinical status (GCS), expressed as an integer ranging in value from 0 (deceased) to 15 (outpatient; best possible GCS).
Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days
Daily orthodema score
Time frame: within 30 days of hospital discharge
Cardiorenal death and Acute Heart Failure Readmission
Time frame: from the time of randomization through 14 days after randomization
measured daily using a continuous scale of 1-100
Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days
Blood measurement
Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days
difference between fluid input and urine output in ml
Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days
cumulative urine output in ml
Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days
cumulative weight loss in pounds
Time frame: within 30 days from randomization
Those days not in the hospital, rehab or a skilled nursing facility from the time of randomization through day 30
Time frame: at two time points: 1) the day of randomization and 2) the next calendar day after protocolized IV diuretics are stopped
As measured by shoebox audiometry with a significant change in hearing threshold (dB) across frequencies from 250-8000 Hz
Time frame: from the time of randomization through the end of protocolized diuretics, approximately 14 days
cumulative sodium excretion estimated using the NRPE (based on spot urine creatinine and sodium)
Time frame: from the time of randomization through the end of protocolized diuretics, approximately 14 days
mean daily sodium excretion estimated using the NRPE (based on spot urine creatinine and sodium)
Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days
measured daily using a continuous scale from 1-100
Time frame: from the time of randomization through the end of protocolized IV diuretics, approximately 14 days
changes in the urinary tubular injury markers such as KIM-1 and NGAL
Time frame: from the ED presentation to hospital discharge, approximately 7 days
number of days in the hospital
Time frame: within 180 days of hospital discharge
all-cause death
Time frame: from the time of randomization through 7 days off protocolized IV diuretics, or discharge
Incidence of symptomatic (lightheaded, chest pain) hypotension (SBP < 80 mmHg confirmed on 2 successive measurements at least 30 minutes apart)
Time frame: from the time of randomization through 7 days off protocolized IV diuretics, or discharge
AKI (defined as a need for renal replacement therapy or KDIGO stage 2 or greater from a serum creatinine at randomization)
Time frame: from the time of randomization through 7 days off protocolized IV diuretics, or discharge
Cardiorenal death or MI as adjudicated by a clinical events committee
Time frame: from the time of randomization through 7 days off protocolized IV diuretics, or discharge
Clinically significant ototoxicity or tinnitus as determined by the study team
Vanderbilt University Medical Center
Other
A Randomized Trial of Protocolized Diuretic Therapy Compared to Standard Care in Emergency Department Patients With Acute Heart Failure
Acronym: ESCALATE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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