Clinical Trial: REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: REal World EVidence for TrEAtment of HyperkaLemia in the Emergency Department (REVEAL - ED): a Multicenter, Prospective, Observational Study
Brief Summary: 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.
Detailed Summary:
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 discha
Sponsor: ZS Pharma, Inc.
Current Primary Outcome: Absolute change in potassium over 4 hours following the initial intervention/treatment for hyperkalemia. [ Time Frame: 4 hours ]
Original Primary Outcome: Absolute change in potassium over 4 hours following the initial intervention/treatment for hyperkalemia. [ Time Frame: 4 hours ]
Current Secondary Outcome: Choice of intervention/treatment [ Time Frame: 4 hours ]
Original Secondary Outcome: Same as current
Information By: ZS Pharma, Inc.
Dates:
Date Received: November 13, 2015
Date Started: October 2015
Date Completion:
Last Updated: May 5, 2016
Last Verified: May 2016
