ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

This study is currently recruiting participants.
Verified by Hadassah Medical Organization, March 2008

Sponsored by: 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

MedlinePlus related topics:   Kidney Failure   

ChemIDplus related topics:   Dextrose    Albuterol sulfate    Albuterol    Levalbuterol hydrochloride    Levalbuterol tartrate    Potassium chloride   

U.S. FDA Resources

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

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:

  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

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


Study ID Numbers:   yc19556-HMO-CTIL
First Received:   September 11, 2005
Last Updated:   March 17, 2008
ClinicalTrials.gov Identifier:   NCT00162487
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:
Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Albuterol
Kidney Failure, Chronic
Hyperkalemia
Water-Electrolyte Imbalance
Kidney Diseases
Metabolic disorder
Kidney Failure

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Adrenergic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Reproductive Control Agents
Pharmacologic Actions
Adrenergic Agonists
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 19, 2008




Links to all studies - primarily for crawlers