REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational Study

Completed

Conditions studied: Hyperkalemia

In brief

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.

Key facts

Study ID

NCT02607085

Run by

ZS Pharma, Inc.

People needed

203

Starts

2015-10-31

Expected to finish

2016-05-31

Last updated by the study team

2017-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Detroit, Michigan, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Stony Brook, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Temple, Texas, United States

Full record on ClinicalTrials.gov

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