Gastrointestinal HemorrhageNCT02928939
Therapeutic Conflicts and Multimorbidity
An observational study of Gastrointestinal Hemorrhage and Diabetes Complications, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage, Diabetes Complications, Multimorbidity
- What is being tested?
- drug-drug or drug-disease interaction
- How many people
- 1,101 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We investigate in the field of multimorbidity in a tertiary hospital regarding therapeutic conflicts of GI bleeding and diabetes exacerbation.
Who may be able to join
- 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)
Who cannot join
- If potential participants have a statement in the electronic medical record or elsewhere to refuse study participation, this represents exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Conflicts in Hospitalized Patients: Retrospective Analyses of Patients With GI Bleeding or Exacerbated Diabetes and Impact of Multimorbidity.
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.
Read the detailed 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.
- Being tested
- drug-drug or drug-disease interaction
- Keywords
- multimorbidity, multiple chronic conditions, drug-drug interactions, drug-disease interactions, polypharmacy, Oral anticoagulants, Steroids
- Medical subject headings
- Gastrointestinal Hemorrhage, Diabetes Complications, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-drug or drug-disease interactionOther
| Study group | Role | What they receive |
|---|---|---|
| Multimorbid patients | Not described Receives: Other: drug-drug or drug-disease interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 5 years
Patients with diabetes mellitus and systemic corticosteroids
Do systemic corticosteroids increase the risk of exacerbation in patients with diabetes mellitus?
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2020
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Center of Competence Multimorbidity, Zurich
- Responsible party
- Sponsor
- Investigators
- Edouard Battegay, Prof. MD, Study director, University Hospital Zurich, Department of Internal MedicineKlarissa Siebenhüner, MD, Principal investigator, University Hospital Zurich, Department of Internal MedicinePatrick Beeler, MD, Study chair, University Hospital Zurich, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928939
- Sponsor's protocol ID
- 2016-00525
- Other IDs
- 2016
- Status last verified
- Apr 2021
- First submitted
- 6 Oct 2016
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Conflicts in Hospitalized Patients: Retrospective Analyses of Patients With GI Bleeding or Exacerbated Diabetes and Impact of Multimorbidity.
- ClinicalTrials.gov ID
- NCT02928939
- Acronym / sponsor ID
- 2016-00525
- Keywords
- multimorbidity, multiple chronic conditions, drug-drug interactions, drug-disease interactions, polypharmacy, Oral anticoagulants, Steroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,101 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Center of Competence Multimorbidity, Zurich
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimorbid patients | – | Other: drug-drug or drug-disease interaction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We investigate in the field of multimorbidity in a tertiary hospital regarding therapeutic conflicts of GI bleeding and diabetes exacerbation.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- If potential participants have a statement in the electronic medical record or elsewhere to refuse study participation, this represents exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug-drug or drug-disease interaction | Other | Multimorbid patients |
Primary outcome
Patients with gastrointestinal bleeding and anticoagulants or antiplatelet drugs
Time frame: 5 years
Do anticoagulants or antiplatelet drugs increase the risk of repeated bleeding in patients with gastrointestinal bleeding?
Patients with diabetes mellitus and systemic corticosteroids
Time frame: 5 years
Do systemic corticosteroids increase the risk of exacerbation in patients with diabetes mellitus?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edouard Battegay, Prof. MD study director
University Hospital Zurich, Department of Internal Medicine
Klarissa Siebenhüner, MD principal investigator
University Hospital Zurich, Department of Internal Medicine
Patrick Beeler, MD study chair
University Hospital Zurich, Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Hemorrhage and Diabetes Complications, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with gastrointestinal bleeding and anticoagulants or antiplatelet drugs (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.