Trial Outcomes & Findings for Vitamins in Nitrous Oxide Study (NCT NCT00655980)
NCT ID: NCT00655980
Last Updated: 2020-10-01
Results Overview
Measured by serial troponin and ECG
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
687 participants
Primary outcome timeframe
first 3 postoperative days
Results posted on
2020-10-01
Participant Flow
687 patients signed consent for enrollment; only 625 were analyzed.
Participant milestones
| Measure |
Treatment
Vitamin B12 and folic acid
Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion
|
Comparator
Nitrous oxide and placebo
Nitrous oxide and placebo
|
Standard of Care
standard of care
standard of care
|
|---|---|---|---|
|
Overall Study
STARTED
|
276
|
281
|
130
|
|
Overall Study
COMPLETED
|
250
|
250
|
125
|
|
Overall Study
NOT COMPLETED
|
26
|
31
|
5
|
Reasons for withdrawal
| Measure |
Treatment
Vitamin B12 and folic acid
Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion
|
Comparator
Nitrous oxide and placebo
Nitrous oxide and placebo
|
Standard of Care
standard of care
standard of care
|
|---|---|---|---|
|
Overall Study
surgery canceled; or subject or anesthes
|
26
|
31
|
5
|
Baseline Characteristics
Some patients had missing genotype
Baseline characteristics by cohort
| Measure |
Treatment
n=250 Participants
Vitamin B12 and folic acid
Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion
|
Comparator
n=250 Participants
Nitrous oxide and placebo
Nitrous oxide and placebo
|
Standard of Care
n=125 Participants
standard of care
standard of care
|
Total
n=625 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 10.6 • n=250 Participants
|
65.2 years
STANDARD_DEVIATION 10.7 • n=250 Participants
|
67.6 years
STANDARD_DEVIATION 10.9 • n=125 Participants
|
65.5 years
STANDARD_DEVIATION 10.7 • n=625 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=250 Participants
|
97 Participants
n=250 Participants
|
45 Participants
n=125 Participants
|
234 Participants
n=625 Participants
|
|
Sex: Female, Male
Male
|
158 Participants
n=250 Participants
|
153 Participants
n=250 Participants
|
80 Participants
n=125 Participants
|
391 Participants
n=625 Participants
|
|
Region of Enrollment
United States
|
250 Participants
n=250 Participants
|
250 Participants
n=250 Participants
|
125 Participants
n=125 Participants
|
625 Participants
n=625 Participants
|
|
Smoking history
|
195 Participants
n=250 Participants
|
175 Participants
n=250 Participants
|
94 Participants
n=125 Participants
|
464 Participants
n=625 Participants
|
|
Diabetes
|
96 Participants
n=250 Participants
|
88 Participants
n=250 Participants
|
39 Participants
n=125 Participants
|
223 Participants
n=625 Participants
|
|
Hypertension
|
200 Participants
n=250 Participants
|
204 Participants
n=250 Participants
|
100 Participants
n=125 Participants
|
504 Participants
n=625 Participants
|
|
Chronic renal failute
|
16 Participants
n=250 Participants
|
35 Participants
n=250 Participants
|
16 Participants
n=125 Participants
|
67 Participants
n=625 Participants
|
|
on hemodialysis
|
1 Participants
n=250 Participants
|
3 Participants
n=250 Participants
|
1 Participants
n=125 Participants
|
5 Participants
n=625 Participants
|
|
Coronary artery disease
|
140 Participants
n=250 Participants
|
148 Participants
n=250 Participants
|
84 Participants
n=125 Participants
|
372 Participants
n=625 Participants
|
|
Congestive heart failure
|
27 Participants
n=250 Participants
|
31 Participants
n=250 Participants
|
15 Participants
n=125 Participants
|
73 Participants
n=625 Participants
|
|
Peripheral vascular disease
|
81 Participants
n=250 Participants
|
85 Participants
n=250 Participants
|
44 Participants
n=125 Participants
|
210 Participants
n=625 Participants
|
|
ASA staging
ASA 1-A normal healthy patient
|
1 Participants
n=250 Participants
|
0 Participants
n=250 Participants
|
0 Participants
n=125 Participants
|
1 Participants
n=625 Participants
|
|
ASA staging
ASA 2 A patient with mild systemic disease
|
45 Participants
n=250 Participants
|
42 Participants
n=250 Participants
|
11 Participants
n=125 Participants
|
98 Participants
n=625 Participants
|
|
ASA staging
ASA 3 - A patient with severe systemic disease
|
199 Participants
n=250 Participants
|
196 Participants
n=250 Participants
|
106 Participants
n=125 Participants
|
501 Participants
n=625 Participants
|
|
ASA staging
ASA 4 -A patient with severe systemic disease tha
|
5 Participants
n=250 Participants
|
10 Participants
n=250 Participants
|
8 Participants
n=125 Participants
|
23 Participants
n=625 Participants
|
|
Lee's revised cardiac risk index (Mean
|
1.9 units on a scale
STANDARD_DEVIATION 0.8 • n=250 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.9 • n=250 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 0.8 • n=125 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.8 • n=625 Participants
|
|
Plasma total homocysteine mol/L
|
13.5 mcmol/L
STANDARD_DEVIATION 5.7 • n=250 Participants
|
13.4 mcmol/L
STANDARD_DEVIATION 5.8 • n=250 Participants
|
11.6 mcmol/L
STANDARD_DEVIATION 4.2 • n=125 Participants
|
13.1 mcmol/L
STANDARD_DEVIATION 5.5 • n=625 Participants
|
|
MTHFR C677T polymorphism
677CC
|
137 Participants
n=242 Participants • Some patients had missing genotype
|
130 Participants
n=245 Participants • Some patients had missing genotype
|
57 Participants
n=102 Participants • Some patients had missing genotype
|
324 Participants
n=589 Participants • Some patients had missing genotype
|
|
MTHFR C677T polymorphism
677CT
|
76 Participants
n=242 Participants • Some patients had missing genotype
|
89 Participants
n=245 Participants • Some patients had missing genotype
|
37 Participants
n=102 Participants • Some patients had missing genotype
|
202 Participants
n=589 Participants • Some patients had missing genotype
|
|
MTHFR C677T polymorphism
677TT
|
29 Participants
n=242 Participants • Some patients had missing genotype
|
26 Participants
n=245 Participants • Some patients had missing genotype
|
8 Participants
n=102 Participants • Some patients had missing genotype
|
63 Participants
n=589 Participants • Some patients had missing genotype
|
|
MTHFR A1298C plymorphism
1298AA
|
133 Participants
n=243 Participants • Some patients had missing genotypes
|
120 Participants
n=244 Participants • Some patients had missing genotypes
|
50 Participants
n=102 Participants • Some patients had missing genotypes
|
303 Participants
n=589 Participants • Some patients had missing genotypes
|
|
MTHFR A1298C plymorphism
1298AC
|
86 Participants
n=243 Participants • Some patients had missing genotypes
|
105 Participants
n=244 Participants • Some patients had missing genotypes
|
45 Participants
n=102 Participants • Some patients had missing genotypes
|
236 Participants
n=589 Participants • Some patients had missing genotypes
|
|
MTHFR A1298C plymorphism
1298CC
|
24 Participants
n=243 Participants • Some patients had missing genotypes
|
19 Participants
n=244 Participants • Some patients had missing genotypes
|
7 Participants
n=102 Participants • Some patients had missing genotypes
|
50 Participants
n=589 Participants • Some patients had missing genotypes
|
|
Medications Aspirin
|
126 Participants
n=250 Participants
|
137 Participants
n=250 Participants
|
69 Participants
n=125 Participants
|
332 Participants
n=625 Participants
|
|
Medications Clopidogrel
|
42 Participants
n=250 Participants
|
45 Participants
n=250 Participants
|
24 Participants
n=125 Participants
|
111 Participants
n=625 Participants
|
|
Medications Warfarin
|
28 Participants
n=250 Participants
|
21 Participants
n=250 Participants
|
13 Participants
n=125 Participants
|
62 Participants
n=625 Participants
|
|
Medications Beta-Blocker
|
119 Participants
n=250 Participants
|
141 Participants
n=250 Participants
|
70 Participants
n=125 Participants
|
330 Participants
n=625 Participants
|
|
ACE-Inhibitor
|
94 Participants
n=250 Participants
|
88 Participants
n=250 Participants
|
43 Participants
n=125 Participants
|
225 Participants
n=625 Participants
|
|
Statin
|
130 Participants
n=250 Participants
|
146 Participants
n=250 Participants
|
69 Participants
n=125 Participants
|
345 Participants
n=625 Participants
|
|
Diuretic
|
79 Participants
n=250 Participants
|
87 Participants
n=250 Participants
|
28 Participants
n=125 Participants
|
194 Participants
n=625 Participants
|
|
Surgical procedure Vascular
|
76 Participants
n=250 Participants
|
87 Participants
n=250 Participants
|
53 Participants
n=125 Participants
|
216 Participants
n=625 Participants
|
|
Surgical procedure Orthopedic
|
88 Participants
n=250 Participants
|
81 Participants
n=250 Participants
|
25 Participants
n=125 Participants
|
194 Participants
n=625 Participants
|
|
Surgical procedure ENT
|
22 Participants
n=250 Participants
|
20 Participants
n=250 Participants
|
17 Participants
n=125 Participants
|
59 Participants
n=625 Participants
|
|
Surgical procedure gyn
|
26 Participants
n=250 Participants
|
21 Participants
n=250 Participants
|
8 Participants
n=125 Participants
|
55 Participants
n=625 Participants
|
|
Surgical procedure Urology
|
22 Participants
n=250 Participants
|
22 Participants
n=250 Participants
|
6 Participants
n=125 Participants
|
50 Participants
n=625 Participants
|
PRIMARY outcome
Timeframe: first 3 postoperative daysMeasured by serial troponin and ECG
Outcome measures
| Measure |
B-Vitamin Group
n=250 Participants
Vitamin B12 and folic acid
Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion
|
Comparator
n=250 Participants
Nitrous oxide and placebo
Nitrous oxide and placebo
|
Standard of Care
n=125 Participants
Patients did neither receive nitrous oxide nor B-vitmamins
|
|---|---|---|---|
|
Myocardial Ischemia
No Cardiac troponin elevation
|
217 Participants
|
216 Participants
|
108 Participants
|
|
Myocardial Ischemia
Cardiac troponin elevation
|
33 Participants
|
34 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 30 day postoperativeMyocardial Infarction per Third Definition of MI
Outcome measures
| Measure |
B-Vitamin Group
n=250 Participants
Vitamin B12 and folic acid
Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion
|
Comparator
n=250 Participants
Nitrous oxide and placebo
Nitrous oxide and placebo
|
Standard of Care
n=125 Participants
Patients did neither receive nitrous oxide nor B-vitmamins
|
|---|---|---|---|
|
Non-fatal MI
|
7 Participants
|
15 Participants
|
8 Participants
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Comparator
Serious events: 3 serious events
Other events: 61 other events
Deaths: 3 deaths
Standard of Care
Serious events: 1 serious events
Other events: 27 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment
n=250 participants at risk
Vitamin B12 and folic acid
Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion
|
Comparator
n=250 participants at risk
Nitrous oxide and placebo
Nitrous oxide and placebo
|
Standard of Care
n=125 participants at risk
standard of care
standard of care
|
|---|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/250 • 30 day
|
1.2%
3/250 • 30 day
|
0.80%
1/125 • 30 day
|
Other adverse events
| Measure |
Treatment
n=250 participants at risk
Vitamin B12 and folic acid
Vitamin B12 and folic acid: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion
|
Comparator
n=250 participants at risk
Nitrous oxide and placebo
Nitrous oxide and placebo
|
Standard of Care
n=125 participants at risk
standard of care
standard of care
|
|---|---|---|---|
|
General disorders
Readmission
|
3.6%
9/250 • 30 day
|
9.2%
23/250 • 30 day
|
10.4%
13/125 • 30 day
|
|
Infections and infestations
Wound Infection
|
6.0%
15/250 • 30 day
|
7.2%
18/250 • 30 day
|
4.0%
5/125 • 30 day
|
|
Respiratory, thoracic and mediastinal disorders
Any Pulmonary
|
1.2%
3/250 • 30 day
|
0.80%
2/250 • 30 day
|
1.6%
2/125 • 30 day
|
|
Cardiac disorders
Cardiovascular
|
2.0%
5/250 • 30 day
|
4.4%
11/250 • 30 day
|
0.80%
1/125 • 30 day
|
|
Renal and urinary disorders
Renal
|
0.00%
0/250 • 30 day
|
0.00%
0/250 • 30 day
|
0.80%
1/125 • 30 day
|
|
Blood and lymphatic system disorders
Bleeding
|
1.6%
4/250 • 30 day
|
0.80%
2/250 • 30 day
|
1.6%
2/125 • 30 day
|
|
Gastrointestinal disorders
Ileus
|
0.40%
1/250 • 30 day
|
0.00%
0/250 • 30 day
|
0.00%
0/125 • 30 day
|
|
Vascular disorders
Deep venous thrombosis
|
0.80%
2/250 • 30 day
|
2.0%
5/250 • 30 day
|
2.4%
3/125 • 30 day
|
Additional Information
Principal Investigator
University of Chicago Medicine
Phone: 7737022544
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place