Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

This study is currently recruiting participants.

Verified by Hadassah Medical Organization, October 2008

First Received: September 11, 2005 Last Updated: October 28, 2008 History of Changes

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00162487

Purpose

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	Intervention
Hyperkalemia Chronic Renal Failure	Drug: Albuterol (1,200 μg) through metered-dose inhaler

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Evaluation of β2 Genetic Polymorphisms and the Effect of Albuterol Inhalation on Potassium and Glucose Plasma Concentration

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Kidney Failure

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	August 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162487

Locations

Israel
Hadassah Medical Organization	Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il
Principal Investigator: Yoseph Caraco, MD

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Yoseph Caraco, MD

Hadassah Medical Organization

More Information

No publications provided

Study ID Numbers:	yc19556-HMO-CTIL
Study First Received:	September 11, 2005
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00162487 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:

Respiratory System Agents
Renal Insufficiency
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Albuterol
Physiological Effects of Drugs
Kidney Failure, Chronic
Reproductive Control Agents
Adrenergic Agonists
Urologic Diseases
Tocolytic Agents
Therapeutic Uses

Water-Electrolyte Imbalance
Kidney Diseases
Metabolic Diseases
Adrenergic beta-Agonists
Hyperkalemia
Anti-Asthmatic Agents
Pharmacologic Actions
Autonomic Agents
Renal Insufficiency, Chronic
Peripheral Nervous System Agents
Bronchodilator Agents
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010