Acid Suppressive Therapy - Review of Appropriateness

NCT02259270 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2017-05-03

No results posted yet for this study

Summary

Acid suppressive therapy (AST) is used in a variety of indications in prevention and treatment of gastric acid related disorders. In recent years, an increase in the use of acid suppressive therapy has been documented. It has generally been accepted that these agents are effective and safe. However, very recently, reports describing hypomagnesaemia, hypocalcemia, vitamin B12 deficiency and enteric infections, were published.

The goal of this study is to evaluate 1) how many cases of long-term ambulatory treatment with AST are initiated during hospital stay (= ASTRA-1), and 2) assess the appropriateness of initiation of AST and the appropriateness of continuation of AST at discharge in a subset of the hospitalized patient population (= ASTRA-2). Finally, the pharmacoeconomic impact of inappropriate AST during hospitalisation will be calculated from these data.

The primary endpoint is defined as the number of patients on long-term ambulatory AST after initiation in the hospital. Secondary endpoints are the appropriateness check of AST both at the level of initiation during hospitalization and at discharge (appropriate continuation); also the impact on the hospital budget (lump sum budget) will be calculated, and potential cost avoidance for long-term ambulatory inappropriate AST will be estimated from a healthcare payer perspective for a period of 1, 3, 6 and 12 months.

Conditions

  • Appropriate Startup of Acid Suppressive Therapy

Interventions

OTHER

Record review

Record review. No intervention with patient or physician. No effect on outcome.

OTHER

AST-history

Checking history (period and number) of ambulatory dispensed AST from 1 year before till 1 year after hospitalisation. No intervention with patient or physician. No effect on outcome.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Thomas De Rijdt, PharmD · UZ Leuven

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02259270 on ClinicalTrials.gov