Therapeutic Conflicts and Multimorbidity

Diabetes Complications Clinical Trial

Official title:

Therapeutic Conflicts in Hospitalized Patients: Retrospective Analyses of Patients With GI Bleeding or Exacerbated Diabetes and Impact of Multimorbidity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928939
• Other study ID #: 2016-00525
• Status: Completed
• Start date: October 2016
• Est. completion date: April 2021

Study information

• Verified date: April 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Clinical practice guidelines do not take into account multimorbidity and various potential therapeutic conflicts. Identifying and quantifying therapeutic conflicts is crucial in multimorbid patients having more than two acute or chronic diseases. Guidance should be available for frequent encountered situations, e.g. gastrointestinal bleeding or exacerbation of diabetes mellitus.

Description:

The study investigates multimorbidity in view of the occurrence of two different therapeutic conflicts or dilemma situations, respectively. The first concerns patients with diagnosis of gastrointestinal bleeding and prescription of anticoagulants or/and antiplatelet drugs (e.g., warfarin, clopidogrel and acetylsalicylic acid) as a risk factor for bleeding events. The second concerns patients with diagnosis of exacerbated diabetes mellitus and prescription of corticosteroids as a risk factor for worsening of blood glucose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1101
• Est. completion date: April 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inpatients at the University Hospital Zurich, USZ
• Male and female patients, aged 18 years or older
• Fulfilling the criteria for Use Case A or B (i.e. patients with gastrointestinal bleeding and anticoagulants or antiplatelet drugs, Use Case A or patients with diabetes mellitus and/or systemic corticosteroids, Use Case B)

Exclusion Criteria:

• If potential participants have a statement in the electronic medical record or elsewhere to refuse study participation, this represents exclusion criteria.

Related Conditions & MeSH terms

• Diabetes Complications
• Gastrointestinal Hemorrhage
• Hemorrhage
• Multimorbidity

Intervention

Other:
• drug-drug or drug-disease interaction

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Center of Competence Multimorbidity, Zurich, University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with gastrointestinal bleeding and anticoagulants or antiplatelet drugs	Do anticoagulants or antiplatelet drugs increase the risk of repeated bleeding in patients with gastrointestinal bleeding?	5 years
Primary	Patients with diabetes mellitus and systemic corticosteroids	Do systemic corticosteroids increase the risk of exacerbation in patients with diabetes mellitus?	5 years