REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational Study (REVEAL-ED)

REal World EVidence for TrEAtment of HyperkaLemia in the Emergency Department (REVEAL - ED): a Multicenter, Prospective, Observational Study

This study evaluates the management of subjects with Standard of Care (SOC) when admitted to the Emergency Department (ED) with hyperkalemia (potassium value ≥ 5.5 mmol/L). Demographics and medical history data, including previous ED visits and/or hospital admissions for hyperkalemia and reason for current ED admission, will be recorded. Subjects who receive an intervention/treatment for hyperkalemia will have study-related potassium values determined at 30 minutes, 1, 2, and 4 hours after the start of treatment. Subjects who receive no intervention/treatment during the initial 4-hour period will have a study-related potassium value determined 4 hours after the baseline potassium measurement. Available data obtained as part of SOC management will include physical examinations, vital signs, fluid intake and urine output, ECGs, clinical laboratory data, and results of chest x-rays. Data regarding the subject's chief complaint upon admission to the ED, the possible cause of the subject's hyperkalemia, and admitting and discharge diagnosis will be recorded; the subject's overall discharge summary will also be collected.

Study Overview

• Status: Completed
• Conditions: Hyperkalemia

Detailed Description

This study evaluates the management of subjects with Standard of Care (SOC) when admitted to the Emergency Department (ED) with hyperkalemia (potassium value ≥ 5.5 mmol/L). If the initial SOC potassium value is suspect, a second confirmatory SOC sample should be obtained and must be ≥ 5.5 mmol/L to continue study participation. It is acceptable for the site to use a point of care analyzer to obtain SOC potassium if this is the ED's standard practice. Demographics and medical history data, including previous ED visits and/or hospital admissions for hyperkalemia and reason for current ED admission, will be recorded. If a baseline study-related potassium value determined prior to the first intervention/treatment is unable to be obtained, the SOC potassium value that qualified the subject for entry into the study will be used as the subject's baseline. Enrollment of subjects with baseline potassium values < 6.0 mmol/L will be limited to a maximum of 50 subjects.

Subjects who receive an intervention/treatment for hyperkalemia (eg, intravenous [IV] calcium, insulin/glucose, beta2-agonists, diuretics, IV bicarbonate, sodium polystyrene sulfonate (SPS), dialysis and/or other intervention for hyperkalemia) will have study-related potassium values drawn at 30 minutes, 1, 2, and 4 hours after the start of treatment. Subjects who receive no intervention/treatment during the initial 4-hour period will have a study-related potassium value drawn 4 hours after the baseline potassium measurement.

The timing of each intervention/treatment and the collection of recordable outcomes following admission to the ED will be recorded, together with the procedure followed, as well as dose and route of administration. In addition concomitant medications will be collected from 14 days prior to ED admission and will continue until discharge from the ED. If the subject is admitted into other care (eg, hospital, ICU, observational unit, etc), post-ED concomitant medication collection will be performed for up to 7 days following admission to that unit or until discharge from that unit, if earlier.

Recordable outcomes will be limited to pulmonary edema, ventricular tachycardia/fibrillation, pulseless electrical activity arrest, new clinically significant electrocardiogram (ECG) changes (including but not limited to severe bradycardia, advanced heart block, bundle branch block, tachycardia [>100 bpm]), palpitations, hypoglycemia, and gastrointestinal-related events (eg, nausea, vomiting, diarrhea) and any other event deemed significant by the investigator. In addition, recordable outcomes requiring positive-pressure ventilation, central venous access, intubation, chest compressions, IV vasopressors, IV vasodilators, IV anti-arrhythmics, IV fluid bolus, and/or emergency dialysis or resulting in death will be collected.

Available data obtained as part of SOC management will include physical examinations, vital signs, fluid intake and urine output, ECGs, clinical laboratory data, and results of chest x-rays. Data regarding the subject's chief complaint upon admission to the ED, the possible cause of the subject's hyperkalemia, and admitting and discharge diagnosis will be recorded; the subject's overall discharge summary will also be collected. As applicable, dates and times will be recorded for the following: ED admission, hospital admission, intensive care unit admission, observation unit admission, step down admission, regular floor admission, discharge (from any and all admissions), dialysis, Do Not Resuscitate order, death, and any other event deemed significant by the investigator. If feasible, billing information and/or Diagnosis-Related Group (DRG) codes and/or Ambulatory Payment Classifications (APC) associated with the ED visit and interventions/treatments will be collected.

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36106
  • Michigan
    • Detroit, Michigan, United States, 48202
    • Royal Oak, Michigan, United States, 48073
  • Missouri
    • Kansas City, Missouri, United States, 64111
    • Saint Louis, Missouri, United States, 63110
  • New York
    • Stony Brook, New York, United States, 11794
  • Ohio
    • Columbus, Ohio, United States, 43210
  • Texas
    • Temple, Texas, United States, 76508

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with moderate to severe hyperkalemia [a Standard of Care (SOC) potassium value ≥ 5.5 mmol/L] admitted to the ED will be enrolled in the study.

Description

Inclusion Criteria:

• Provision of written informed consent.
• 18 years of age or older.
• Hyperkalemia confirmed in the ED (documented SOC potassium value ≥ 5.5 mmol/L; after 50 subjects with a SOC potassium value < 6.0 mmol/L have been enrolled, this criterion increases to ≥ 6.0 mmol/L).

Exclusion Criteria:

• Subjects who, in the opinion of investigator, are unable to perform the tasks associated with the protocol.
• Subjects participating in another clinical study (eg, investigational agent), which could impact this study.
• Subjects who previously enrolled in this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in potassium over 4 hours following the initial intervention/treatment for hyperkalemia.	If no intervention/treatment for hyperkalemia during ED admission, then change over 4 hours following baseline potassium measurement.	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choice of intervention/treatment	Changes in study-related potassium following intervention/treatment.	4 hours

Collaborators and Investigators

• Sponsor: ZS Pharma, Inc.

Publications and helpful links

Helpful Links

• Clinical Summary

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2015
• Primary Completion (Actual): April 30, 2016
• Study Completion (Actual): May 31, 2016

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Water-Electrolyte Imbalance; Emergencies; Hyperkalemia
• Other Study ID Numbers: ZS-007