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

NCT00919152 | Completed

• 1 other identifier: 0245-09-EX
• Study Type: observational
• Target: 534
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Ulcer Prophylaxis

Keywords

stress ulcer prophylaxis; intensive care; Critically ill; proton pump inhibitors; pharmacoeconomics

Outcome Measures

Primary Outcomes (1)

• Determine qualifying criteria of enteral versus parenteral PPIs

  Determine correlates (qualifying criteria) of patients initiated on enteral versus parenteral PPIs as first choice in ICU and after discharge from ICU

  2006-2008

Secondary Outcomes (1)

• Potential savings in drug costs from parenteral to enteral PPI therapy

  2006-2008

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• Patients ineligible to receive a PPI (e.g. hypersensitivity to any PPI)

Sponsors & Collaborators

• University of Nebraska: lead
• Takeda: collaborator

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Keith M Olsen, PharmD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 12, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2012
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

US (1)