Trial Outcomes & Findings for ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients (NCT NCT01867047)

Results Overview

The number of participants with mild hypotension (Systolic Blood Pressure (SBP) less than 85 mmHG) will be recorded.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

From baseline to discharge from hospital (approximately 5 days)

Results posted on

2017-09-28

Participant Flow

Patients were prescreened by the study team and then identified and presented to the surgeon during the preoperative clinic visit. Once IRB approval was granted on 8-9-2012 study team started screening the clinic schedule for potential participants.

Randomization of participants occurred only if the proposed inclusion/exclusion criteria were met.

Participant milestones

Participant milestones
Measure	Continuation Group ACE-I Continuation group: Subjects take ACE-I through day of surgery	Cessation Group ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery
Overall Study STARTED	31	28
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Continuation Group ACE-I Continuation group: Subjects take ACE-I through day of surgery	Cessation Group ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery
Overall Study Lost to Follow-up	3	3
Overall Study Withdrawal by Subject	2	0
Overall Study Physician Decision	2	0
Overall Study surgery not indicated in protocol	1	2

Baseline Characteristics

ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuation Group n=23 Participants ACE-I Continuation group: Subjects take ACE-I through day of surgery	Cessation Group n=23 Participants ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	63.3 years STANDARD_DEVIATION 10.8 • n=5 Participants	63.7 years STANDARD_DEVIATION 8.7 • n=7 Participants	63.5 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to discharge from hospital (approximately 5 days)

The number of participants with mild hypotension (Systolic Blood Pressure (SBP) less than 85 mmHG) will be recorded.

Outcome measures

Outcome measures
Measure	Continuation Group n=23 Participants ACE-I Continuation group: Subjects take ACE-I through day of surgery	Cessation Group n=23 Participants ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery
Number of Participants With Mild Hypotension Intraoperative	14 Participants	9 Participants
Number of Participants With Mild Hypotension Postoperative	3 Participants	2 Participants

PRIMARY outcome

Timeframe: From baseline to discharge from hospital (approximately 5 days)

The number of participants with severe hypotension (Systolic Blood Pressure less than 65 mmHG) will be recorded.