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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Takeda
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00919152
First received: June 10, 2009
Last updated: October 30, 2009
Last verified: October 2009
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: July 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919152

Contacts
Contact: Keith M Olsen, PharmD 402-559-9016 kolsen@unmc.edu
Contact: Jayashri Sankaranarayanan, PhD 402-559-5267 jsankara@unmc.edu

Locations
United States, Nebraska
The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Keith m olsen, pharmd    402-559-9016    kolsen@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Takeda
Investigators
Principal Investigator: Keith M Olsen, PharmD University of Nebraska
  More Information

No publications provided

Responsible Party: Keith M Olsen, Universt of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00919152     History of Changes
Other Study ID Numbers: 245-09-EX
Study First Received: June 10, 2009
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
stress ulcer prophylaxis
intensive care
Critically ill
proton pump inhibitors
pharmacoeconomics

Additional relevant MeSH terms:
Ulcer
Pathologic Processes
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014