REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: 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). 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.

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.