Trial Outcomes & Findings for Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery (NCT NCT00393848)
NCT ID: NCT00393848
Last Updated: 2014-06-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Perioperative and discharge
Results posted on
2014-06-02
Participant Flow
Participant milestones
| Measure |
Experiment 1 - Amino Acid Supplement
Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
|
Experiment 1 - Standard of Care
Usual clinical care with no dietary intervention.
|
Experiment 2 - Ketoconazole
200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
Experiment 2 - Placebo
Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
9
|
6
|
9
|
|
Overall Study
COMPLETED
|
16
|
9
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Experiment 1 - Amino Acid Supplement
Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
|
Experiment 1 - Standard of Care
Usual clinical care with no dietary intervention.
|
Experiment 2 - Ketoconazole
200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
Experiment 2 - Placebo
Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
|---|---|---|---|---|
|
Overall Study
Surgical schedule
|
0
|
0
|
0
|
1
|
|
Overall Study
Personal reasons
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery
Baseline characteristics by cohort
| Measure |
Experiment 1 - Amino Acid Supplement
n=16 Participants
Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
|
Experiment 1 - Standard of Care
n=9 Participants
Usual clinical care - no dietary intervention.
|
Experiment 2 - Ketoconazole
n=4 Participants
200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
Experiment 2 - Placebo
n=8 Participants
Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
Total
n=37 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 7 • n=5 Participants
|
56 years
STANDARD_DEVIATION 8 • n=7 Participants
|
44 years
STANDARD_DEVIATION 15 • n=5 Participants
|
46 years
STANDARD_DEVIATION 15 • n=4 Participants
|
51 years
STANDARD_DEVIATION 11 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
8 participants
n=4 Participants
|
37 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Perioperative and dischargeOutcome measures
| Measure |
Experiment 1 - Amino Acid Supplement
n=16 Participants
Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
|
Experiment 1 - Standard of Care
n=9 Participants
Usual clinical care without dietary intervention
|
Experiment 2 - Ketoconazole
n=4 Participants
200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
Experiment 2 - Placebo
n=8 Participants
Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
|---|---|---|---|---|
|
Muscle Protein Synthesis
Perioperative MPS
|
1.38 %/d
Standard Error 0.12
|
0.84 %/d
Standard Error 0.11
|
1.42 %/d
Standard Error 0.48
|
1.36 %/d
Standard Error 0.22
|
|
Muscle Protein Synthesis
Discharge MPS
|
1.23 %/d
Standard Error 0.16
|
1.49 %/d
Standard Error 0.18
|
NA %/d
Standard Error NA
Not performed
|
NA %/d
Standard Error NA
Not performed
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks post surgeryPopulation: Measure not performed in Experiment 2
Outcome measures
| Measure |
Experiment 1 - Amino Acid Supplement
n=16 Participants
Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
|
Experiment 1 - Standard of Care
n=9 Participants
Usual clinical care without dietary intervention
|
Experiment 2 - Ketoconazole
200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
Experiment 2 - Placebo
Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
|---|---|---|---|---|
|
Change in Maximal Voluntary Contraction
|
0.68 kg/kg leg lean mass
Standard Error 0.3
|
0.34 kg/kg leg lean mass
Standard Error 0.32
|
—
|
—
|
Adverse Events
Experiment 1 - Amino Acid Supplement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experiment 1 - Standard of Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Experiment 2 - Ketoconazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experiment 2 - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experiment 1 - Amino Acid Supplement
n=16 participants at risk
Essential amino acid supplement: 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
|
Experiment 1 - Standard of Care
n=9 participants at risk
Usual clinical care with no dietary intervention.
|
Experiment 2 - Ketoconazole
n=6 participants at risk
200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
Experiment 2 - Placebo
n=9 participants at risk
Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mastectomy for breast cancer
|
0.00%
0/16
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/9
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place