Trial Outcomes & Findings for Oxidative Stress and Surgical Recovery (NCT NCT04732000)
NCT ID: NCT04732000
Last Updated: 2025-04-30
Results Overview
STAT3 phosphorylation in MDSC cells is measured in all MDSC cells before (T0) and one day after surgery (T1) using mass cytometry. The median phosphorylation in this cell population is then determined for each time point. The change in phosphorylation is expressed as the arc sinh ratio of these two medians (ratio = arc sinh \[median pSTAT3-T1/median pSTAT3-T0\]).
COMPLETED
PHASE2
30 participants
Measurements will be made in samples collected before and 24 hours after surgery.
2025-04-30
Participant Flow
30 participants signed consent, 24 were assigned to a study arm.
Participant milestones
| Measure |
N-acetyl Cysteine
N-acetyl cysteine intravenous infusion started during the clinically indicated surgery at a rate of 50mg/kg over 1 hour followed by 50mg/kg over 3 hours to an accumulated total of 100 mg/kg over 4 hours.
|
Normal Saline
Normal Saline intravenous infusion at a time and rate to mimic the active treatment given over 4 hours beginning during the clinically indicated surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxidative Stress and Surgical Recovery
Baseline characteristics by cohort
| Measure |
N-acetyl Cysteine
n=10 Participants
N-acetyl cysteine intravenous infusion started during the clinically indicated surgery at a rate of 50mg/kg over 1 hour followed by 50mg/kg over 3 hours to an accumulated total of 100 mg/kg over 4 hours.
|
Normal Saline
n=11 Participants
Normal Saline intravenous infusion at a time and rate to mimic the active treatment given over 4 hours beginning during the clinically indicated surgery.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
n=5 Participants
|
68.0 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Body mass index
|
27.7 kg/m2
n=5 Participants
|
28.6 kg/m2
n=7 Participants
|
28.3 kg/m2
n=5 Participants
|
|
Western Ontario & McMaster Universities Osteoarthritis Index - Pain
|
24.5 score on a scale
n=5 Participants
|
17.0 score on a scale
n=7 Participants
|
22.0 score on a scale
n=5 Participants
|
|
Western Ontario & McMaster Universities Osteoarthritis Index - Function
|
38.0 Score on a scale
n=5 Participants
|
32.0 Score on a scale
n=7 Participants
|
37.0 Score on a scale
n=5 Participants
|
|
Opioids POD1 (IV Diluadid Eq.)
|
3.4 mg/mL
n=5 Participants
|
1.9 mg/mL
n=7 Participants
|
2.3 mg/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Measurements will be made in samples collected before and 24 hours after surgery.Population: Participants with samples that passes quality control were included in the analysis
STAT3 phosphorylation in MDSC cells is measured in all MDSC cells before (T0) and one day after surgery (T1) using mass cytometry. The median phosphorylation in this cell population is then determined for each time point. The change in phosphorylation is expressed as the arc sinh ratio of these two medians (ratio = arc sinh \[median pSTAT3-T1/median pSTAT3-T0\]).
Outcome measures
| Measure |
N-acetyl Cysteine
n=10 Participants
N-acetyl cysteine intravenous infusion started during the clinically indicated surgery at a rate of 50mg/kg over 1 hour followed by 50mg/kg over 3 hours to an accumulated total of 100 mg/kg over 4 hours.
|
Normal Saline
n=9 Participants
Normal Saline intravenous infusion at a time and rate to mimic the active treatment given over 4 hours beginning during the clinically indicated surgery.
|
|---|---|---|
|
Phosphorylation of STAT-3 in MDSC (Myeloid-derived Suppressor Cells)
|
2.162 STAT3 archsinh ratio
Interval 1.966 to 2.264
|
2.025 STAT3 archsinh ratio
Interval 1.955 to 2.221
|
PRIMARY outcome
Timeframe: post-operative week 6The Brief Pain Inventory was used to measure pain and pain interference following surgery. BPI Pain Composite Score was derived from worst pain, least pain, average pain, and pain right now subscale scores. BPI Pain Interference Composite Score (representing how pain interferes with daily life) was derived from general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life subscale scores. Each composite score is the median value of the combined median values for each participant of the respective subscale scores (range for subscale and overall scores: 0 to 10, higher scores indicate more severe pain/pain interference).
Outcome measures
| Measure |
N-acetyl Cysteine
n=10 Participants
N-acetyl cysteine intravenous infusion started during the clinically indicated surgery at a rate of 50mg/kg over 1 hour followed by 50mg/kg over 3 hours to an accumulated total of 100 mg/kg over 4 hours.
|
Normal Saline
n=11 Participants
Normal Saline intravenous infusion at a time and rate to mimic the active treatment given over 4 hours beginning during the clinically indicated surgery.
|
|---|---|---|
|
Brief Pain Inventory Pain Score
BPI Pain Composite Score
|
1.3 score on a scale
Interval 1.0 to 2.8
|
1.0 score on a scale
Interval 0.3 to 1.3
|
|
Brief Pain Inventory Pain Score
BPI Pain Interference Composite Score
|
2.5 score on a scale
Interval 2.0 to 3.0
|
1.0 score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline through post-op day 1 (composite scores over 24 hours following surgery)Population: Participants who completed the protocol are included in the analysis.
The Brief Pain Inventory will be used to measure pain following surgery at various time points. A composite score will be calculated 24 hours post op and will constitute the secondary end point. Overall score: median and interquartile range are reported across scores for worst pain, least pain, average pain, and right now pain. Pain interference score: represents how pain interferes with daily life. Score ranges: 0 to 10, higher scores indicate more severe pain.
Outcome measures
| Measure |
N-acetyl Cysteine
n=10 Participants
N-acetyl cysteine intravenous infusion started during the clinically indicated surgery at a rate of 50mg/kg over 1 hour followed by 50mg/kg over 3 hours to an accumulated total of 100 mg/kg over 4 hours.
|
Normal Saline
n=11 Participants
Normal Saline intravenous infusion at a time and rate to mimic the active treatment given over 4 hours beginning during the clinically indicated surgery.
|
|---|---|---|
|
Pain Score
Baseline - overall pain
|
5.5 score on a scale
Interval 2.1 to 7.1
|
4.5 score on a scale
Interval 3.3 to 7.3
|
|
Pain Score
Post-op day 1 - overall pain
|
4.3 score on a scale
Interval 3.5 to 5.4
|
4.0 score on a scale
Interval 2.5 to 6.5
|
|
Pain Score
Baseline - pain interference
|
7.0 score on a scale
Interval 5.3 to 7.8
|
5.0 score on a scale
Interval 4.0 to 7.0
|
|
Pain Score
Post-op day 1 - pain interference
|
6.5 score on a scale
Interval 2.8 to 8.5
|
2.0 score on a scale
Interval 2.0 to 5.5
|
Adverse Events
Normal Saline
N-acetyl Cysteine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Saline
n=11 participants at risk
Normal Saline intravenous infusion at a time and rate to mimic the active treatment given over 4 hours beginning during the clinically indicated surgery.
|
N-acetyl Cysteine
n=13 participants at risk
N-acetyl cysteine intravenous infusion started during the clinically indicated surgery at a rate of 50mg/kg over 1 hour followed by 50mg/kg over 3 hours to an accumulated total of 100 mg/kg over 4 hours.
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal Cramps
|
0.00%
0/11 • 6 weeks
|
7.7%
1/13 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/11 • 6 weeks
|
7.7%
1/13 • 6 weeks
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • 6 weeks
|
15.4%
2/13 • 6 weeks
|
|
Investigations
Fever (≥37.2 C)
|
0.00%
0/11 • 6 weeks
|
15.4%
2/13 • 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • 6 weeks
|
7.7%
1/13 • 6 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • 6 weeks
|
7.7%
1/13 • 6 weeks
|
|
Injury, poisoning and procedural complications
Swelling of surgical leg and foot
|
9.1%
1/11 • 6 weeks
|
7.7%
1/13 • 6 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • 6 weeks
|
7.7%
1/13 • 6 weeks
|
|
Infections and infestations
Blisters above right hip
|
0.00%
0/11 • 6 weeks
|
7.7%
1/13 • 6 weeks
|
|
Investigations
Chills
|
9.1%
1/11 • 6 weeks
|
0.00%
0/13 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Rash at site of regional anesthesia
|
9.1%
1/11 • 6 weeks
|
0.00%
0/13 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Full body rash
|
9.1%
1/11 • 6 weeks
|
0.00%
0/13 • 6 weeks
|
|
Investigations
Hb ≤6.4 g/dL
|
9.1%
1/11 • 6 weeks
|
0.00%
0/13 • 6 weeks
|
|
Infections and infestations
Shingles
|
9.1%
1/11 • 6 weeks
|
0.00%
0/13 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place