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Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

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ClinicalTrials.gov Identifier: NCT00162487
Recruitment Status : Unknown
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : September 13, 2005
Last Update Posted : October 29, 2008
Sponsor:
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE September 11, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date October 29, 2008
Study Start Date  ICMJE August 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
  • 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
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperkalemia
  • Chronic Renal Failure
Intervention  ICMJE Drug: Albuterol (1,200 μg) through metered-dose inhaler
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 11, 2005)
150
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162487
Other Study ID Numbers  ICMJE yc19556-HMO-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization
PRS Account 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