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Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

Primary Purpose

Hyperkalemia, Chronic Renal Failure

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Albuterol (1,200 μg) through metered-dose inhaler
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperkalemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients regularly attending the nephrological clinic or the dialysis unit persistent potassium concentration above 5 mEq/L Exclusion Criteria: Patients suffering from active ischemic heart disease Patient with a recent history of arrhythmia Patients treated regularly with ß blockers Patients treated regularly with salbutamol or other ß2AR agonists Patients suffering from persistent tachycardia (pulse > 100 beats/min) Patients who are hemodynamically unstable Patients suffering from any acute illness

Sites / Locations

  • Hadassah Medical OrganizationRecruiting

Outcomes

Primary Outcome Measures

The extent of decrease in plasma potassium concentration
The extent of increase in plasma glucose concentration
Plasma concentration of albuterol

Secondary Outcome Measures

Full Information

First Posted
September 11, 2005
Last Updated
October 28, 2008
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00162487
Brief Title
Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation
Official Title
Evaluation of β2 Genetic Polymorphisms and the Effect of Albuterol Inhalation on Potassium and Glucose Plasma Concentration
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

Brief Summary
Several studies have indicated that albuterol administered either intravenously or by inhalation can significantly reduce plasma potassium concentration in patients suffering from chronic renal failure.In conjunction with the decrease in potassium concentration a modest rise in glucose concentration is usually noted. These metabolic effects are characterized by rapid onset occurring as early as 3-5 minutes following salbutamol administration and lasting for at least 1 hour. The role played by ß2AR polymorphisms in determining the bronchial and vascular response to ß2AR agonist drugs, have been confirmed by several studies. The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and the metabolic effects of inhaled albuterol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia, Chronic Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Albuterol (1,200 μg) through metered-dose inhaler
Primary Outcome Measure Information:
Title
The extent of decrease in plasma potassium concentration
Title
The extent of increase in plasma glucose concentration
Title
Plasma concentration of albuterol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients regularly attending the nephrological clinic or the dialysis unit persistent potassium concentration above 5 mEq/L Exclusion Criteria: Patients suffering from active ischemic heart disease Patient with a recent history of arrhythmia Patients treated regularly with ß blockers Patients treated regularly with salbutamol or other ß2AR agonists Patients suffering from persistent tachycardia (pulse > 100 beats/min) Patients who are hemodynamically unstable Patients suffering from any acute illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoseph Caraco, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Yoseph Caraco, MD

12. IPD Sharing Statement

Learn more about this trial

Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

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