Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2005

Last Updated Date

October 28, 2008

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00162487 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

Official Title ^ICMJE

Evaluation of β2 Genetic Polymorphisms and the Effect of Albuterol Inhalation on Potassium and Glucose Plasma Concentration

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Hyperkalemia
Chronic Renal Failure

Intervention ^ICMJE

Drug: Albuterol (1,200 μg) through metered-dose inhaler

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00162487

Responsible Party

Study ID Numbers ^ICMJE

yc19556-HMO-CTIL

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Yoseph Caraco, MD

Hadassah Medical Organization

Information Provided By

Hadassah Medical Organization

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP