Trial Outcomes & Findings for Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery (NCT NCT00791648)
NCT ID: NCT00791648
Last Updated: 2019-09-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
653 participants
Primary outcome timeframe
postoperative day 2
Results posted on
2019-09-16
Participant Flow
36 patients consented patients were excluded prior to randomization 14 withdrew, 12 did not require surgery, 4 had unreported baseline live dysfunction, 2 developed acute coronary syndrome, 2 had statin intolerance, 1 died prior to study intervention and surgery, 1 enrolled in another drug study.
Participant milestones
| Measure |
Statin
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
308
|
309
|
|
Overall Study
COMPLETED
|
308
|
307
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Statin
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Statin
n=308 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=307 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
Total
n=615 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
67 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
214 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
427 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
308 participants
n=5 Participants
|
307 participants
n=7 Participants
|
615 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: postoperative day 2Outcome measures
| Measure |
Statin
n=308 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=307 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Number of Participants With Acute Kidney Injury
|
64 Participants
|
60 Participants
|
PRIMARY outcome
Timeframe: while in ICU (about 2 days)Outcome measures
| Measure |
Statin
n=308 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=307 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Number of Participants With Delirium
|
69 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: while in ICU (about 2 days)Outcome measures
| Measure |
Statin
n=308 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=307 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Number of Participants Requiring Dialysis
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: postoperative day 1Outcome measures
| Measure |
Statin
n=308 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=307 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Liver Enzyme: Aspartate Aminotransferase Level
|
49 units/liter
Interval 25.0 to 105.0
|
52 units/liter
Interval 27.0 to 146.0
|
SECONDARY outcome
Timeframe: while in ICU (about 2 days)Outcome measures
| Measure |
Statin
n=308 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=307 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Number of Participants With Stroke
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: until postoperative hospital discharge (about 7 days)Outcome measures
| Measure |
Statin
n=308 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=307 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Number of Participants That Died
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: anesthesia induction and POD 1Population: This marker was only measured in a subset of the total study population, chosen at random.
mtDNA copy number
Outcome measures
| Measure |
Statin
n=164 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=168 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Mitochondrial Function--mtDNA Copy Number
at anesthesia induction
|
0.40 au
Interval 0.19 to 0.99
|
.48 au
Interval 0.21 to 1.1
|
|
Mitochondrial Function--mtDNA Copy Number
POD 1
|
0.3 au
Interval 0.17 to 0.3
|
0.43 au
Interval 0.17 to 0.88
|
SECONDARY outcome
Timeframe: anesthesia induction, after CPB, and POD 1Population: This marker was only measured in a subset of the total study population, chosen at random.
lactate / pyruvate ratio
Outcome measures
| Measure |
Statin
n=80 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=82 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Mitochondrial Function--lactate / Pyruvate Ratio
at anesthesia induction
|
0.04 ratio
Interval 0.03 to 0.06
|
0.04 ratio
Interval 0.03 to 0.06
|
|
Mitochondrial Function--lactate / Pyruvate Ratio
after CPB
|
0.06 ratio
Interval 0.03 to 0.09
|
0.06 ratio
Interval 0.03 to 0.09
|
|
Mitochondrial Function--lactate / Pyruvate Ratio
POD 1
|
0.04 ratio
Interval 0.03 to 0.05
|
0.04 ratio
Interval 0.03 to 0.06
|
SECONDARY outcome
Timeframe: anesthesia induction and POD 1Population: This marker was only measured in a subset of the total study population, chosen at random.
PGC-1alpha RNA expression
Outcome measures
| Measure |
Statin
n=79 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=76 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Mitochondrial Function--PGC-1alpha RNA Expression
at anesthesia induction
|
0.54 au
Interval 0.18 to 1.86
|
0.84 au
Interval 0.23 to 2.51
|
|
Mitochondrial Function--PGC-1alpha RNA Expression
POD 1
|
1.02 au
Interval 0.27 to 2.45
|
1.37 au
Interval 0.54 to 3.88
|
SECONDARY outcome
Timeframe: anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, and Post op Day (POD) 1, 2, 3Population: This marker was only measured in a subset of the total study population, chosen at random.
tissue inhibitor metaloproteinase-2 x insulin-like growth factor binding protein-7
Outcome measures
| Measure |
Statin
n=200 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=200 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Urine Markers of Renal Injury
at anesthesia induction
|
0.119 (ng/ml)^2/1000
Interval 0.046 to 0.317
|
0.098 (ng/ml)^2/1000
Interval 0.037 to 0.262
|
|
Urine Markers of Renal Injury
30 minutes into cardiopulmonary bypass (CPB)
|
0.171 (ng/ml)^2/1000
Interval 0.062 to 0.442
|
0.169 (ng/ml)^2/1000
Interval 0.056 to 0.36
|
|
Urine Markers of Renal Injury
after CPB
|
0.218 (ng/ml)^2/1000
Interval 0.077 to 0.561
|
0.219 (ng/ml)^2/1000
Interval 0.087 to 0.619
|
|
Urine Markers of Renal Injury
ICU admission
|
0.096 (ng/ml)^2/1000
Interval 0.043 to 0.238
|
0.112 (ng/ml)^2/1000
Interval 0.043 to 0.285
|
|
Urine Markers of Renal Injury
6 hours post-op
|
0.210 (ng/ml)^2/1000
Interval 0.108 to 0.452
|
0.207 (ng/ml)^2/1000
Interval 0.084 to 0.438
|
|
Urine Markers of Renal Injury
POD 1
|
0.189 (ng/ml)^2/1000
Interval 0.04 to 0.489
|
0.186 (ng/ml)^2/1000
Interval 0.061 to 0.499
|
|
Urine Markers of Renal Injury
POD 2
|
0.170 (ng/ml)^2/1000
Interval 0.05 to 0.38
|
0.115 (ng/ml)^2/1000
Interval 0.048 to 0.328
|
|
Urine Markers of Renal Injury
POD 3
|
0.134 (ng/ml)^2/1000
Interval 0.046 to 0.309
|
0.102 (ng/ml)^2/1000
Interval 0.054 to 0.287
|
SECONDARY outcome
Timeframe: anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.Population: This marker was only measured in a subset of the total study population, chosen at random.
Outcome measures
| Measure |
Statin
n=200 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=200 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Plasma Markers of Oxidative Stress: f2-Isoprostanes
at anesthesia induction
|
29.4 pg/ml
Interval 20.1 to 41.1
|
28.8 pg/ml
Interval 20.7 to 41.0
|
|
Plasma Markers of Oxidative Stress: f2-Isoprostanes
30 minutes into cardiopulmonary bypass (CPB)
|
41.6 pg/ml
Interval 29.3 to 60.3
|
39 pg/ml
Interval 27.2 to 57.4
|
|
Plasma Markers of Oxidative Stress: f2-Isoprostanes
after CPB
|
32.3 pg/ml
Interval 23.6 to 46.8
|
31.5 pg/ml
Interval 23.6 to 45.0
|
|
Plasma Markers of Oxidative Stress: f2-Isoprostanes
ICU admission
|
32.1 pg/ml
Interval 22.1 to 42.4
|
31.6 pg/ml
Interval 23.6 to 44.5
|
|
Plasma Markers of Oxidative Stress: f2-Isoprostanes
6 hours post-op
|
32.1 pg/ml
Interval 26.7 to 42.4
|
41 pg/ml
Interval 35.2 to 49.0
|
|
Plasma Markers of Oxidative Stress: f2-Isoprostanes
POD 1
|
28.1 pg/ml
Interval 21.5 to 39.4
|
30.2 pg/ml
Interval 21.9 to 41.6
|
|
Plasma Markers of Oxidative Stress: f2-Isoprostanes
POD 2
|
28.5 pg/ml
Interval 21.7 to 50.5
|
37 pg/ml
Interval 28.0 to 47.6
|
|
Plasma Markers of Oxidative Stress: f2-Isoprostanes
POD 3
|
32.7 pg/ml
Interval 27.9 to 54.3
|
26.5 pg/ml
Interval 23.2 to 49.8
|
SECONDARY outcome
Timeframe: anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.Population: This marker was only measured in a subset of the total study population, chosen at random.
Outcome measures
| Measure |
Statin
n=200 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=200 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Plasma Markers of Oxidative Stress: Isofurans
POD 2
|
40 pg/ml
Interval 22.8 to 59.0
|
36 pg/ml
Interval 22.0 to 46.0
|
|
Plasma Markers of Oxidative Stress: Isofurans
at anesthesia induction
|
45 pg/ml
Interval 32.9 to 70.0
|
48.4 pg/ml
Interval 34.1 to 77.6
|
|
Plasma Markers of Oxidative Stress: Isofurans
30 minutes into cardiopulmonary bypass (CPB)
|
59.9 pg/ml
Interval 37.9 to 93.8
|
56.2 pg/ml
Interval 42.1 to 89.4
|
|
Plasma Markers of Oxidative Stress: Isofurans
after CPB
|
57.6 pg/ml
Interval 41.1 to 83.8
|
60.6 pg/ml
Interval 38.1 to 90.2
|
|
Plasma Markers of Oxidative Stress: Isofurans
ICU admission
|
63.7 pg/ml
Interval 45.0 to 92.4
|
64 pg/ml
Interval 45.2 to 92.3
|
|
Plasma Markers of Oxidative Stress: Isofurans
6 hours post-op
|
42.5 pg/ml
Interval 22.5 to 63.9
|
40.4 pg/ml
Interval 29.5 to 59.1
|
|
Plasma Markers of Oxidative Stress: Isofurans
POD 1
|
48 pg/ml
Interval 32.1 to 82.5
|
50.9 pg/ml
Interval 34.1 to 85.1
|
|
Plasma Markers of Oxidative Stress: Isofurans
POD 3
|
33.5 pg/ml
Interval 25.3 to 53.9
|
38 pg/ml
Interval 16.5 to 50.2
|
SECONDARY outcome
Timeframe: anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.Population: This marker was only measured in a subset of the total study population, chosen at random.
Outcome measures
| Measure |
Statin
n=178 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=179 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Urine Markers of Oxidative Stress: f2-Isoprostanes
at anesthesia induction
|
1.369 ng/mg creatinine
Interval 0.856 to 2.183
|
1.478 ng/mg creatinine
Interval 0.836 to 2.237
|
|
Urine Markers of Oxidative Stress: f2-Isoprostanes
30 minutes into cardiopulmonary bypass (CPB)
|
1.750 ng/mg creatinine
Interval 0.948 to 2.718
|
2.29 ng/mg creatinine
Interval 1.241 to 4.027
|
|
Urine Markers of Oxidative Stress: f2-Isoprostanes
after CPB
|
2.71 ng/mg creatinine
Interval 1.247 to 5.38
|
2.729 ng/mg creatinine
Interval 1.719 to 4.889
|
|
Urine Markers of Oxidative Stress: f2-Isoprostanes
ICU admission
|
1.816 ng/mg creatinine
Interval 0.92 to 3.167
|
2.9 ng/mg creatinine
Interval 1.85 to 5.71
|
|
Urine Markers of Oxidative Stress: f2-Isoprostanes
6 hours post-op
|
1.464 ng/mg creatinine
Interval 0.839 to 2.389
|
1.77 ng/mg creatinine
Interval 1.19 to 3.51
|
|
Urine Markers of Oxidative Stress: f2-Isoprostanes
POD 1
|
1.056 ng/mg creatinine
Interval 0.602 to 1.756
|
1.143 ng/mg creatinine
Interval 0.634 to 1.924
|
|
Urine Markers of Oxidative Stress: f2-Isoprostanes
POD 2
|
0.792 ng/mg creatinine
Interval 0.604 to 1.36
|
0.88 ng/mg creatinine
Interval 0.7 to 1.548
|
|
Urine Markers of Oxidative Stress: f2-Isoprostanes
POD 3
|
0.870 ng/mg creatinine
Interval 0.527 to 1.601
|
0.875 ng/mg creatinine
Interval 0.812 to 1.235
|
SECONDARY outcome
Timeframe: anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.Population: This marker was only measured in a subset of the total study population, chosen at random.
Outcome measures
| Measure |
Statin
n=178 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=178 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Urine Markers of Oxidative Stress: Isofurans
at anesthesia induction
|
2.146 (ng/ml)^2/1000
Interval 1.321 to 3.316
|
2.146 (ng/ml)^2/1000
Interval 1.321 to 3.316
|
|
Urine Markers of Oxidative Stress: Isofurans
30 minutes into cardiopulmonary bypass (CPB)
|
2.48 (ng/ml)^2/1000
Interval 1.545 to 3.18
|
2.48 (ng/ml)^2/1000
Interval 1.545 to 3.18
|
|
Urine Markers of Oxidative Stress: Isofurans
after CPB
|
3.709 (ng/ml)^2/1000
Interval 2.279 to 6.283
|
3.709 (ng/ml)^2/1000
Interval 2.279 to 6.283
|
|
Urine Markers of Oxidative Stress: Isofurans
ICU admission
|
3.734 (ng/ml)^2/1000
Interval 2.877 to 8.18
|
3.734 (ng/ml)^2/1000
Interval 2.877 to 8.18
|
|
Urine Markers of Oxidative Stress: Isofurans
6 hours post-op
|
3.310 (ng/ml)^2/1000
Interval 1.9 to 5.42
|
3.070 (ng/ml)^2/1000
Interval 1.912 to 5.99
|
|
Urine Markers of Oxidative Stress: Isofurans
POD 1
|
2.344 (ng/ml)^2/1000
Interval 1.503 to 3.633
|
2.344 (ng/ml)^2/1000
Interval 1.503 to 3.633
|
|
Urine Markers of Oxidative Stress: Isofurans
POD 2
|
2.2 (ng/ml)^2/1000
Interval 1.428 to 4.05
|
2.2 (ng/ml)^2/1000
Interval 1.428 to 4.05
|
|
Urine Markers of Oxidative Stress: Isofurans
POD 3
|
2.16 (ng/ml)^2/1000
Interval 1.43 to 2.84
|
2.16 (ng/ml)^2/1000
Interval 1.43 to 2.84
|
SECONDARY outcome
Timeframe: anesthesia induction, ICU admission, and POD 1Population: This marker was only measured in a subset of the total study population, chosen at random.
measurements of neuronal injury (ubiquitin C-terminal hydrolase-1)
Outcome measures
| Measure |
Statin
n=200 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=200 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Plasma Markers of Inflammation: Measurements of Neuronal Injury (Ubiquitin C-terminal Hydrolase-1)
at anesthesia induction
|
6.2 ng/ml
Interval 4.2 to 10.0
|
6.7 ng/ml
Interval 4.1 to 10.2
|
|
Plasma Markers of Inflammation: Measurements of Neuronal Injury (Ubiquitin C-terminal Hydrolase-1)
ICU admission
|
12.3 ng/ml
Interval 7.9 to 21.7
|
11.6 ng/ml
Interval 8.0 to 23.9
|
|
Plasma Markers of Inflammation: Measurements of Neuronal Injury (Ubiquitin C-terminal Hydrolase-1)
POD 1
|
12.8 ng/ml
Interval 8.3 to 19.5
|
12.2 ng/ml
Interval 8.5 to 17.9
|
SECONDARY outcome
Timeframe: anesthesia induction, ICU admission, and POD 1Population: This marker was only measured in a subset of the total study population, chosen at random.
measurements of blood brain barrier disruption (S100 calcium-binding protein B)
Outcome measures
| Measure |
Statin
n=200 Participants
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=200 Participants
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Plasma Markers of Inflammation: Blood Brain Barrier Disruption (S100 Calcium-binding Protein B)
POD 1
|
46.1 pg/ml
Interval 30.4 to 64.2
|
45 pg/ml
Interval 32.7 to 67.9
|
|
Plasma Markers of Inflammation: Blood Brain Barrier Disruption (S100 Calcium-binding Protein B)
at anesthesia induction
|
17.5 pg/ml
Interval 12.5 to 25.0
|
17 pg/ml
Interval 11.5 to 23.1
|
|
Plasma Markers of Inflammation: Blood Brain Barrier Disruption (S100 Calcium-binding Protein B)
ICU admission
|
163.9 pg/ml
Interval 110.7 to 255.9
|
163.1 pg/ml
Interval 97.3 to 278.5
|
Adverse Events
Statin
Serious events: 14 serious events
Other events: 308 other events
Deaths: 0 deaths
Placebo
Serious events: 19 serious events
Other events: 307 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Statin
n=308 participants at risk
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=307 participants at risk
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
1.6%
5/308 • Number of events 5 • First 10 post-op days
|
0.65%
2/307 • Number of events 2 • First 10 post-op days
|
|
Infections and infestations
Severe Infection
|
0.65%
2/308 • Number of events 2 • First 10 post-op days
|
1.3%
4/307 • Number of events 4 • First 10 post-op days
|
|
Vascular disorders
Severe Peripheral Vascular Ischemia
|
0.32%
1/308 • Number of events 1 • First 10 post-op days
|
0.33%
1/307 • Number of events 1 • First 10 post-op days
|
|
Skin and subcutaneous tissue disorders
Sternal Dehiscence
|
0.00%
0/308 • First 10 post-op days
|
0.65%
2/307 • Number of events 2 • First 10 post-op days
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.32%
1/308 • Number of events 1 • First 10 post-op days
|
0.33%
1/307 • Number of events 1 • First 10 post-op days
|
|
Respiratory, thoracic and mediastinal disorders
Severe Respiratory Distress
|
0.65%
2/308 • Number of events 2 • First 10 post-op days
|
0.33%
1/307 • Number of events 1 • First 10 post-op days
|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
0.00%
0/308 • First 10 post-op days
|
0.33%
1/307 • Number of events 1 • First 10 post-op days
|
|
Cardiac disorders
Severe Heart Failure
|
0.32%
1/308 • Number of events 1 • First 10 post-op days
|
0.00%
0/307 • First 10 post-op days
|
|
Injury, poisoning and procedural complications
Fall with Factured Hip
|
0.00%
0/308 • First 10 post-op days
|
0.33%
1/307 • Number of events 1 • First 10 post-op days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/308 • First 10 post-op days
|
0.65%
2/307 • Number of events 2 • First 10 post-op days
|
|
Blood and lymphatic system disorders
Coagulapathy
|
0.00%
0/308 • First 10 post-op days
|
0.33%
1/307 • Number of events 1 • First 10 post-op days
|
|
Congenital, familial and genetic disorders
Cardiac Tamponade
|
0.00%
0/308 • First 10 post-op days
|
0.33%
1/307 • Number of events 1 • First 10 post-op days
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/308 • First 10 post-op days
|
0.33%
1/307 • Number of events 1 • First 10 post-op days
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.00%
0/308 • First 10 post-op days
|
0.33%
1/307 • Number of events 1 • First 10 post-op days
|
|
Injury, poisoning and procedural complications
Intra-operative Injury to Blood Vessel
|
0.32%
1/308 • Number of events 1 • First 10 post-op days
|
0.00%
0/307 • First 10 post-op days
|
|
Blood and lymphatic system disorders
Idiopathic Thrombocytopenia Purpura
|
0.32%
1/308 • Number of events 1 • First 10 post-op days
|
0.00%
0/307 • First 10 post-op days
|
Other adverse events
| Measure |
Statin
n=308 participants at risk
atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
|
Placebo
n=307 participants at risk
placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
|
|---|---|---|
|
Infections and infestations
Fever
|
16.2%
50/308 • Number of events 125 • First 10 post-op days
|
16.9%
52/307 • Number of events 117 • First 10 post-op days
|
|
Cardiac disorders
Tachycardia
|
15.9%
49/308 • Number of events 215 • First 10 post-op days
|
13.7%
42/307 • Number of events 190 • First 10 post-op days
|
|
Cardiac disorders
Hypotension
|
61.0%
188/308 • Number of events 1032 • First 10 post-op days
|
62.5%
192/307 • Number of events 1073 • First 10 post-op days
|
|
Cardiac disorders
Vasoplegia
|
39.0%
120/308 • Number of events 342 • First 10 post-op days
|
38.4%
118/307 • Number of events 357 • First 10 post-op days
|
|
Cardiac disorders
Decreased Cardiac Output
|
60.7%
187/308 • Number of events 643 • First 10 post-op days
|
63.2%
194/307 • Number of events 623 • First 10 post-op days
|
|
Surgical and medical procedures
Anemia
|
59.4%
183/308 • Number of events 1608 • First 10 post-op days
|
56.0%
172/307 • Number of events 1537 • First 10 post-op days
|
|
Infections and infestations
Leukocytosis
|
45.8%
141/308 • Number of events 513 • First 10 post-op days
|
45.6%
140/307 • Number of events 522 • First 10 post-op days
|
|
Cardiac disorders
Lactic Acidosis
|
17.9%
55/308 • Number of events 194 • First 10 post-op days
|
19.2%
59/307 • Number of events 202 • First 10 post-op days
|
|
Hepatobiliary disorders
Transaminemia
|
7.5%
23/308 • Number of events 29 • First 10 post-op days
|
12.7%
39/307 • Number of events 46 • First 10 post-op days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place