Trial Outcomes & Findings for Polypharmacy and Outcomes After Elective Noncardiac Surgery (NCT NCT03133182)

NCT ID: NCT03133182

Last Updated: 2025-01-24

Results Overview

death from any cause

Recruitment status

COMPLETED

Target enrollment

266499 participants

Primary outcome timeframe

from day of surgery up to 90 days after surgery

Results posted on

2025-01-24

Participant Flow

Participant milestones

Participant milestones
Measure
Polypharmacy
People taking \>=5 unique prescription drugs in the 3 months prior to surgery Polypharmacy: Patients who are 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
Overall Study
STARTED
146029
120470
Overall Study
COMPLETED
146029
120470
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Polypharmacy and Outcomes After Elective Noncardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Polypharmacy
n=146029 Participants
People taking \>=5 unique prescription drugs in the 3 months prior to surgery Polypharmacy: Patients who are taking \>=5 unique prescription drugs in the 3 months prior to surgery
No Polypharmacy
n=120470 Participants
People taking \<5 unique prescription drugs in the 3 months prior to surgery
Total
n=266499 Participants
Total of all reporting groups
Age, Continuous
75 years
STANDARD_DEVIATION 6 • n=99 Participants
73 years
STANDARD_DEVIATION 6 • n=107 Participants
74 years
STANDARD_DEVIATION 6 • n=206 Participants
Sex: Female, Male
Female
81922 Participants
n=99 Participants
59512 Participants
n=107 Participants
141434 Participants
n=206 Participants
Sex: Female, Male
Male
64107 Participants
n=99 Participants
60958 Participants
n=107 Participants
125065 Participants
n=206 Participants
Income quintile
3 Income group
n=99 Participants
3 Income group
n=107 Participants
3 Income group
n=206 Participants

PRIMARY outcome

Timeframe: from day of surgery up to 90 days after surgery

death from any cause

Outcome measures

Outcome measures
Measure
Polypharmacy
n=146029 Participants
People taking \>=5 unique prescription drugs in the 3 months prior to surgery Polypharmacy: Patients who are taking \>=5 unique prescription drugs in the 3 months prior to surgery
No Polypharmacy
n=120470 Participants
People taking \<5 unique prescription drugs in the 3 months prior to surgery
Mortality
4356 Participants
1919 Participants

SECONDARY outcome

Timeframe: From day of surgery to day of hospital discharge, up to 365 days after surgery

Patient with a complication based on clusters of ICD-10 Type 2 codes collected in the hospital record

Outcome measures

Outcome measures
Measure
Polypharmacy
n=146029 Participants
People taking \>=5 unique prescription drugs in the 3 months prior to surgery Polypharmacy: Patients who are taking \>=5 unique prescription drugs in the 3 months prior to surgery
No Polypharmacy
n=120470 Participants
People taking \<5 unique prescription drugs in the 3 months prior to surgery
Complications
31570 Participants
19815 Participants

SECONDARY outcome

Timeframe: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first

Number of days in hospital after surgery

Outcome measures

Outcome measures
Measure
Polypharmacy
n=146029 Participants
People taking \>=5 unique prescription drugs in the 3 months prior to surgery Polypharmacy: Patients who are taking \>=5 unique prescription drugs in the 3 months prior to surgery
No Polypharmacy
n=120470 Participants
People taking \<5 unique prescription drugs in the 3 months prior to surgery
Length of Stay
5 Days
Interval 4.0 to 8.0
5 Days
Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: date of surgery up to 90 days after surgery

Costs related to medical care paid for by the provincial health insurance system

Outcome measures

Outcome measures
Measure
Polypharmacy
n=146029 Participants
People taking \>=5 unique prescription drugs in the 3 months prior to surgery Polypharmacy: Patients who are taking \>=5 unique prescription drugs in the 3 months prior to surgery
No Polypharmacy
n=120470 Participants
People taking \<5 unique prescription drugs in the 3 months prior to surgery
Costs of Care
24064 Canadian Dollars
Standard Deviation 16624
20251 Canadian Dollars
Standard Deviation 24424

SECONDARY outcome

Timeframe: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first

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)

Outcome measures

Outcome measures
Measure
Polypharmacy
n=146029 Participants
People taking \>=5 unique prescription drugs in the 3 months prior to surgery Polypharmacy: Patients who are taking \>=5 unique prescription drugs in the 3 months prior to surgery
No Polypharmacy
n=120470 Participants
People taking \<5 unique prescription drugs in the 3 months prior to surgery
Institutional Discharge
34128 Participants
23098 Participants

SECONDARY outcome

Timeframe: From the date of hospital discharge to 30 days after the date of discharge

Acute hospital readmission after discharge from index hospitalization

Outcome measures

Outcome measures
Measure
Polypharmacy
n=146029 Participants
People taking \>=5 unique prescription drugs in the 3 months prior to surgery Polypharmacy: Patients who are taking \>=5 unique prescription drugs in the 3 months prior to surgery
No Polypharmacy
n=120470 Participants
People taking \<5 unique prescription drugs in the 3 months prior to surgery
Hospital Readmission
13202 Participants
8097 Participants

Adverse Events

Polypharmacy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4356 deaths

No Polypharmacy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1919 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel McIsaac

The Ottawa Hospital

Phone: 613-761-4940

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place