Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

Chronic Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00162487
• Other study ID #: yc19556-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2005
• Last updated: October 28, 2008
• Start date: August 2002

Study information

• Verified date: October 2008
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients regularly attending the nephrological clinic or the dialysis unit

• persistent potassium concentration above 5 mEq/L

Exclusion Criteria:

1. Patients suffering from active ischemic heart disease

2. Patient with a recent history of arrhythmia

3. Patients treated regularly with ß blockers

4. Patients treated regularly with salbutamol or other ß2AR agonists

5. Patients suffering from persistent tachycardia (pulse > 100 beats/min)

6. Patients who are hemodynamically unstable

7. Patients suffering from any acute illness

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Hyperkalemia
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The extent of decrease in plasma potassium concentration
Primary	The extent of increase in plasma glucose concentration
Primary	Plasma concentration of albuterol