PolypharmacyNCT03133182

Polypharmacy and Outcomes After Elective Noncardiac Surgery

An observational study of Polypharmacy and Surgical Procedure, Operative, run by Ottawa Hospital Research Institute.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study investigates the association of preoperative polypharmacy with outcomes and healthcare resource utilization in a population-based sample of older patients enrolled in a universal pharmacare program Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Polypharmacy, Surgical Procedure, Operative, Morality
What is being tested?: Polypharmacy
How many people: 266,499 participants
Where: No sites listed yet
Study dates: Apr 2002to Mar 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years and older
All sexes
No healthy volunteers
Older adult

Study population: Population-based sample of people having their first eligible surgery during the study period

Who may be able to join

Intermediate to high risk elective non-cardiac surgery
Age >=66 on day of surgery

Who cannot join

About this study

Official title: Association of Polypharmacy With Outcomes After Elective Noncardiac Surgery: a Population-based Cohort Study

Read the detailed description

Multilevel multivariable regression analysis will be used to investigate the adjusted association between preoperative polypharmacy and postoperative outcomes and healthcare resource utilization. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.

Conditions: Polypharmacy, Surgical Procedure, Operative, Morality, Epidemiology
Being tested: Polypharmacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PolypharmacyDrug
Patients who are taking >=5 unique prescription drugs in the 3 months prior to surgery

Study groups in NCT03133182
Study group	Role	What they receive
Polypharmacy		People taking >=5 unique prescription drugs in the 3 months prior to surgery Receives: Drug: Polypharmacy
No polypharmacy		People taking <5 unique prescription drugs in the 3 months prior to surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Mortality
death from any cause
Measured: from day of surgery up to 90 days after surgery

Secondary outcomes (5)

Complications
Patient with a complication based on clusters of ICD-10 Type 2 codes collected in the hospital record
Measured: From day of surgery to day of hospital discharge, up to 365 days after surgery
Length of Stay
Number of days in hospital after surgery
Measured: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
Costs of Care
Costs related to medical care paid for by the provincial health insurance system
Measured: date of surgery up to 90 days after surgery
Institutional Discharge
A discharge location at the end of the surgical episode of care that is not back to the patient's original residence (specifically respite or long term care)
Measured: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
Hospital Readmission
Acute hospital readmission after discharge from index hospitalization
Measured: From the date of hospital discharge to 30 days after the date of discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2002Mar 2014

First posted28 Apr 2017
Study startApr 2002
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PolypharmacyStudies 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: Cohort
Time perspective: Retrospective
Enrolment: 266,499 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03133182
Sponsor's protocol ID: DM5
Status last verified: Dec 2024
First submitted: 18 Apr 2017
Last updated: 24 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

McIsaac DI, Wong CA, Bryson GL, van Walraven C. Association of Polypharmacy with Survival, Complications, and Healthcare Resource Use after Elective Noncardiac Surgery: A Population-based Cohort Study. Anesthesiology. 2018 Jun;128(6):1140-1150. doi: 10.1097/ALN.0000000000002124.
PubMed 29443701

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Improving Medication Management in World Trade Center Responders
Polypharmacy
Recruiting
PRE-EMPTIVE PHARMACOGENOMICS IN ACUTE CARE SETTINGS WITH HEALTH ECONOMIC EVALUATIONS (PHOENIX TRIAL)
Pharmacogenomic Drug Interaction
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
RecruitingObservational study
IPGx PILOT Whole Genome Sequencing Extension Cohort
Adverse Drug Reaction (ADR), Polypharmacy Patients
Not yet recruitingPhase 1/2
Mechanistic Evaluation of Polypharmacy Effects for Pain
Chronic Lower Back Pain (CLBP)

All Polypharmacy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association of Polypharmacy With Outcomes After Elective Noncardiac Surgery: a Population-based Cohort Study
ClinicalTrials.gov ID: NCT03133182
Acronym / sponsor ID: DM5
Conditions: Polypharmacy, Surgical Procedure, Operative, Morality, Epidemiology
Study type: Observational
Recruitment status: Completed
Enrolment: 266,499 participants (actual)
Lead sponsor: Ottawa Hospital Research InstituteUniversity, hospital or other
Study start: Apr 2002 (actual)
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 28 Apr 2017 (actual)
Results: Posted 24 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Polypharmacy	–	Drug: PolypharmacyPeople taking >=5 unique prescription drugs in the 3 months prior to surgery
No polypharmacy	–	–People taking <5 unique prescription drugs in the 3 months prior to surgery

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: Population-based sample of people having their first eligible surgery during the study period

Key inclusion criteria (2 listed)

Intermediate to high risk elective non-cardiac surgery
Age >=66 on day of surgery

Key exclusion criteria (1 listed)

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
PolypharmacyPatients who are taking >=5 unique prescription drugs in the 3 months prior to surgery	Drug	Polypharmacy

Primary outcome

Mortality
Time frame: from day of surgery up to 90 days after surgery
death from any cause

5 secondary outcomes

Complications
Time frame: From day of surgery to day of hospital discharge, up to 365 days after surgery
Length of Stay
Time frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
Costs of Care
Time frame: date of surgery up to 90 days after surgery
Institutional Discharge
Time frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
Hospital Readmission
Time frame: From the date of hospital discharge to 30 days after the date of discharge

Results and safety

Results posted to the registry on 24 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Polypharmacy	146,029	146,029
No Polypharmacy	120,470	120,470

Primary outcome: Mortality

Time frame: from day of surgery up to 90 days after surgery. Count of participants. Unit: Participants

Measure	Polypharmacy n = 146029	No Polypharmacy n = 120470
Value	4356	1919

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within 90 days of surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Polypharmacy	0 of 0	0 of 0	4,356 of 146,029
No Polypharmacy	0 of 0	0 of 0	1,919 of 120,470

Limitations and caveats (from the sponsor): We are unable to fully account for unmeasured confounders and indication bias. We were not able to account for granular patient-level data. We used health administrative data that were not initially collected for research purposes; risk of misclassification bias should be considered. Our polypharmacy exposure did not account for the potential differing risk impacts or appropriateness of different drugs. We were unable to account for medication underutilization which could bias results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29443701McIsaac DI, Wong CA, Bryson GL, van Walraven C. Association of Polypharmacy with Survival, Complications, and Healthcare Resource Use after Elective Noncardiac Surgery: A Population-based Cohort Study. Anesthesiology. 2018 Jun;128(6):1140-1150. doi: 10.1097/ALN.0000000000002124.
Individual participant dataSharing planned: No

Related trials for Polypharmacy

Active, not recruiting
Improving Medication Management in World Trade Center Responders
Polypharmacy
Recruiting
PRE-EMPTIVE PHARMACOGENOMICS IN ACUTE CARE SETTINGS WITH HEALTH ECONOMIC EVALUATIONS (PHOENIX TRIAL)
Pharmacogenomic Drug Interaction
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
RecruitingObservational study
IPGx PILOT Whole Genome Sequencing Extension Cohort
Adverse Drug Reaction (ADR), Polypharmacy Patients
Not yet recruitingPhase 1/2
Mechanistic Evaluation of Polypharmacy Effects for Pain
Chronic Lower Back Pain (CLBP)

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Polypharmacy and Surgical Procedure, Operative, run by Ottawa Hospital Research Institute.

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 2 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mortality (time frame: from day of surgery up to 90 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03133182, which also lists 1 linked publication.

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 24 Jan 2025.