Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00162487
• Collaborator: (none)
• Enrollment: 150
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperkalemia; Chronic Renal Failure	Drug: Albuterol (1,200 μg) through metered-dose inhaler	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of β2 Genetic Polymorphisms and the Effect of Albuterol Inhalation on Potassium and Glucose Plasma Concentration
• Study Start Date: Aug 1, 2002

Outcome Measures

Primary Outcome Measures

1. The extent of decrease in plasma potassium concentration []

2. The extent of increase in plasma glucose concentration []

3. Plasma concentration of albuterol []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel	91120

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

• Principal Investigator: Yoseph Caraco, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00162487
• Other Study ID Numbers: yc19556-HMO-CTIL
• First Posted: Sep 13, 2005
• Last Update Posted: Oct 29, 2008
• Last Verified: Oct 1, 2008

• Additional relevant MeSH terms: Kidney Failure, Chronic; Hyperkalemia; Albuterol

Study Results

No Results Posted as of Oct 29, 2008