Trial Outcomes & Findings for Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty (NCT NCT03973320)

Last Updated: 2024-12-27

Results Overview

The association between levels and length of intraoperative controlled hypotension and incidence rates of individual and composite outcome of any of the following events: (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death. If any of these events are positive, then the composite outcome will be positive. The units of measurement will be the same.

Recruitment status

COMPLETED

Target enrollment

11292 participants

Primary outcome timeframe

Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery

Results posted on

2024-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Primary Total Hip Arthroplasty This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty Chart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.
Overall Study STARTED	11292
Overall Study COMPLETED	11292
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Total Hip Arthroplasty Without Complications n=11224 Participants This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty Chart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.	Primary Total Hip Arthroplasty With Common Complications n=68 Participants This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty Chart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.	Total n=11292 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	75.6 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	5955 Participants n=5 Participants	30 Participants n=7 Participants	5985 Participants n=5 Participants
Sex: Female, Male Male	5269 Participants n=5 Participants	38 Participants n=7 Participants	5307 Participants n=5 Participants
Race/Ethnicity, Customized Race: White	9842 Participants n=5 Participants	49 Participants n=7 Participants	9891 Participants n=5 Participants
BMI (Body Mass Index)	28.1 kg/m^2 n=5 Participants	28 kg/m^2 n=7 Participants	28.1 kg/m^2 n=5 Participants
Anesthetic type: Spinal	3584 Participants n=5 Participants	16 Participants n=7 Participants	3600 Participants n=5 Participants
Anesthetic type: Epidural/CSE	7640 Participants n=5 Participants	52 Participants n=7 Participants	7692 Participants n=5 Participants
ASA of 1 & 2	9254 Participants n=5 Participants	37 Participants n=7 Participants	9291 Participants n=5 Participants
ASA of 3	1970 Participants n=5 Participants	31 Participants n=7 Participants	2001 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery

Population: 21 patients out of 11,292 fit complication definition.

Outcome measures

Outcome measures
Measure	Primary Total Hip Arthroplasty n=21 Participants This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty Chart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.
Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality Myocardial Infarction	16 Participants
Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality Stroke	2 Participants
Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality In-Hospital mortality	0 Participants
Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality 30-day mortality	3 Participants

Adverse Events

Primary Total Hip Arthroplasty

Serious events: 0 serious events

Other events: 18 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Primary Total Hip Arthroplasty n=11292 participants at risk This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty Chart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.
Cardiac disorders Myocardial Infarction	0.14% 16/11292 • The time period to which adverse events (i.e. deaths) were collected was up to 30 days following a total hip arthroplasty surgery. The primary outcome was "the incidences of (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death, and (iv) calculated perioperative intraoperative blood loss", and these events were recorded retrospectively. As a result, none of the three types of adverse events posed a risk to participants. This study collects past information and no new data was actively collected from individuals.
Nervous system disorders Stroke	0.02% 2/11292 • The time period to which adverse events (i.e. deaths) were collected was up to 30 days following a total hip arthroplasty surgery. The primary outcome was "the incidences of (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death, and (iv) calculated perioperative intraoperative blood loss", and these events were recorded retrospectively. As a result, none of the three types of adverse events posed a risk to participants. This study collects past information and no new data was actively collected from individuals.

Additional Information

Dr. Jiabin Liu

Hospital for Special Surgery, Anesthesiology

Phone: 2126061036

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place