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Economic Outcomes of Enteral and Parenteral Proton Pump Inhibitor (PPI) Use in the Intensive Care Unit (ICU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00919152
First Posted: June 12, 2009
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by (Responsible Party):
Keith Olsen, PharmD, FCCP, FCCM, University of Nebraska
  Purpose

This study will be a retrospective electronic medical chart review of all patients admitted to adult intensive care medicine units (ICU) at The Nebraska Medical Center over a three-year period from January 2006 through December 2008. The study will have three primary aims:

  • Aim 1: Determine correlates (qualifying criteria) of patients initiated on enteral versus parenteral PPIs as first choice in ICU and after discharge from ICU,
  • Aim 2: Based on correlates determine number of patients receiving parenteral PPIs that could receive enteral therapy as first choice in ICU and after discharge from ICU,
  • Aim 3: Estimate the potential savings in drug costs associated with conversion of eligible patients from parenteral to enteral PPI therapy with emphasis on lansoprazole solutab in the ICU and conversion of eligible patients requiring continued AST from parenteral to enteral PPI therapy after discharge from ICU.

Condition
Stress Ulcer Prophylaxis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Correlates of Economic Outcomes of Enteral and Parenteral PPI Use in the ICU and After Discharge

Further study details as provided by Keith Olsen, PharmD, FCCP, FCCM, University of Nebraska:

Primary Outcome Measures:
  • Determine correlates (qualifying criteria) of patients initiated on enteral versus parenteral PPIs as first choice in ICU and after discharge from ICU [ Time Frame: 2006-2008 ]

Secondary Outcome Measures:
  • Estimate the potential savings in drug costs associated with conversion of eligible patients from parenteral to enteral PPI therapy with emphasis on lansoprazole solutab in the ICU [ Time Frame: 2006-2008 ]

Enrollment: 534
Study Start Date: July 2009
Study Completion Date: January 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients greater than 18 years admitted to the ICU during 2006-2008 (January 2006 through December 2008; 3-year period)
Criteria

Inclusion Criteria:

  • All patients greater than 18 years admitted to the ICU during 2006-2008 (January 2006 through December 2008; 3-year period)

Exclusion Criteria:

  • Patients ineligible to receive a PPI (e.g. hypersensitivity to any PPI)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919152


Locations
United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Takeda
Investigators
Principal Investigator: Keith M Olsen, PharmD University of Nebraska
  More Information

Responsible Party: Keith Olsen, PharmD, FCCP, FCCM, Professor and Chair, University of Nebraska
ClinicalTrials.gov Identifier: NCT00919152     History of Changes
Other Study ID Numbers: 245-09-EX
First Submitted: June 10, 2009
First Posted: June 12, 2009
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Keith Olsen, PharmD, FCCP, FCCM, University of Nebraska:
stress ulcer prophylaxis
intensive care
Critically ill
proton pump inhibitors
pharmacoeconomics

Additional relevant MeSH terms:
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action