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

NCT02607085 | Completed

• 1 other identifier: ZS-007
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 8

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.

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Choice of intervention/treatment

  4 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Provision of written informed consent.
• 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.

Sponsors & Collaborators

• ZS Pharma, Inc.: lead

Study Sites (8)

Unknown Facility

Montgomery, Alabama, 36106, United States

Location

Unknown Facility

Detroit, Michigan, 48202, United States

Location

Unknown Facility

Royal Oak, Michigan, 48073, United States

Location

Unknown Facility

Kansas City, Missouri, 64111, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Stony Brook, New York, 11794, United States

Location

Unknown Facility

Columbus, Ohio, 43210, United States

Location

Unknown Facility

Temple, Texas, 76508, United States

Location

Related Links

• Clinical Summary

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Henrik Rasmussen, MD, PhD

  ZS Pharma, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 17, 2015
• Study Start: October 31, 2015
• Primary Completion: April 30, 2016
• Study Completion: May 31, 2016
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

US (8)