Trial Outcomes & Findings for Steroids in Bilateral Total Knee Replacement (NCT NCT01399268)

NCT ID: NCT01399268

Last Updated: 2017-07-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 24 hours postoperative
• Results posted on: 2017-07-31

Participant Flow

Participant milestones

Measure	Steroid Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times	Control Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Steroid n=15 Participants Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times	Control n=15 Participants Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times	Total n=30 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 7 • n=15 Participants	71 years STANDARD_DEVIATION 9 • n=15 Participants	67.5 years STANDARD_DEVIATION 8 • n=30 Participants
Sex: Female, Male Female	9 Participants n=15 Participants	6 Participants n=15 Participants	15 Participants n=30 Participants
Sex: Female, Male Male	6 Participants n=15 Participants	9 Participants n=15 Participants	15 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	15 participants n=15 Participants	15 participants n=15 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 24 hours postoperative

Outcome measures

Measure	Steroid n=15 Participants Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times	Control n=15 Participants Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Decrease in IL6 Level	359.4 pg/ml Interval 300.0 to 400.0	381.6 pg/ml Interval 300.0 to 400.0

SECONDARY outcome

Timeframe: 24 hours postoperative

Population: Data were not collected

Outcome measures

Measure	Steroid Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times	Control Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Desmosine Level	0	0

SECONDARY outcome

Timeframe: 24 hours postoperative

Outcome measures

Measure	Steroid n=15 Participants Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times	Control n=15 Participants Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Blood Glucose	133 mg/dL Standard Deviation 30	102 mg/dL Standard Deviation 17

SECONDARY outcome

Timeframe: Length of hospital stay, an expected average of 5 days

Outcome measures

Measure	Steroid n=15 Participants Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times	Control n=15 Participants Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Length of Hospital Stay	5 days Standard Deviation 0.9	5 days Standard Deviation 0.8

SECONDARY outcome

Timeframe: Length of hospital stay, an expected average of 5 days

Outcome measures

Measure	Steroid n=15 Participants Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times	Control n=15 Participants Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
In Hospital Infection Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Length of hospital stay, an expected average of 5 days

Outcome measures

Measure	Steroid n=15 Participants Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times	Control n=15 Participants Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Measure	Steroid n=15 Participants Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times	Control n=15 Participants Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Ability to Ambulate	1 Participants	1 Participants

Adverse Events

Steroid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jules

HSS

Phone: 212.606.1206

Email: JulesK@hss.edu

Results disclosure agreements

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