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NCT02607085: REVEAL-ED

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

Completed Last updated 8 June 2017
What this trial tests

trial in Hyperkalemia in 203 participants. Completed in 31 May 2016.

Timeline
31 October 2015
Primary endpoint
30 April 2016
31 May 2016

Quick facts

Lead sponsorZS Pharma, Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment203
Start date31 October 2015
Primary completion30 April 2016
Estimated completion31 May 2016
Sites8 locations across United States

Conditions studied

Sponsor

ZS Pharma, Inc. — full company profile →

Who can join

18 and older, any sex, with Hyperkalemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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). 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate: A Phase II, Randomized, Double-blind, Placebo-controlled Study (ENERGIZE).
    Peacock WF, Rafique Z, Vishnevskiy K, Michelson E, et al · · 2020 · cited 57× · PMID 32149451 · DOI 10.1111/acem.13954
  2. Study design of Real World Evidence for Treatment of Hyperkalemia in the Emergency Department (REVEAL-ED): a multicenter, prospective, observational study.
    Rafique Z, Kosiborod M, Clark CL, Singer AJ, et al · · 2017 · cited 4× · PMID 29026889 · DOI 10.15441/ceem.17.207
  3. Net clinical benefit of patiromer for acute hyperkalemia: a post-hoc analysis of the reduce trial.
    McArthur R, Peacock WF, Budden J, Rafique Z. · · 2025 · PMID 41178555 · DOI 10.1080/07853890.2025.2581912

Verify or expand the search:

Other recruiting trials for Hyperkalemia

Currently open trials in the same condition.

Other ZS Pharma, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02607085.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing