Trial Outcomes & Findings for Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery (NCT NCT00656292)
NCT ID: NCT00656292
Last Updated: 2017-05-19
Results Overview
Description: AST is an enzyme found in high amounts in liver, heart, and muscle cells. This test is mainly done along with other tests such as alkaline phosphatase and bilirubin to diagnose and monitor liver disease. This test evaluates hepatocyte integrity, as serum levels of this enzyme rise in response to a variety of forms of injury to hepatic cells. The normal range is 10 to 40 U/L.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs
Results posted on
2017-05-19
Participant Flow
Participant milestones
| Measure |
Simvastatin
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
29
|
|
Overall Study
COMPLETED
|
29
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Simvastatin
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Screen failure
|
1
|
2
|
Baseline Characteristics
Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
Baseline characteristics by cohort
| Measure |
Simvastatin
n=32 Participants
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
n=29 Participants
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
29 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrsDescription: AST is an enzyme found in high amounts in liver, heart, and muscle cells. This test is mainly done along with other tests such as alkaline phosphatase and bilirubin to diagnose and monitor liver disease. This test evaluates hepatocyte integrity, as serum levels of this enzyme rise in response to a variety of forms of injury to hepatic cells. The normal range is 10 to 40 U/L.
Outcome measures
| Measure |
Simvastatin
n=29 Participants
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
n=24 Participants
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
|---|---|---|
|
Median Concentration of Aspartate Aminotransferase (AST)
baseline
|
24.5 U/L
Interval 18.8 to 31.0
|
24.5 U/L
Interval 21.0 to 27.8
|
|
Median Concentration of Aspartate Aminotransferase (AST)
time 0 hours
|
21.0 U/L
Interval 18.0 to 24.0
|
20.0 U/L
Interval 17.0 to 24.0
|
|
Median Concentration of Aspartate Aminotransferase (AST)
time 8 hours
|
29.0 U/L
Interval 21.0 to 33.0
|
25.0 U/L
Interval 19.3 to 31.5
|
|
Median Concentration of Aspartate Aminotransferase (AST)
time 24 hours
|
41.5 U/L
Interval 28.0 to 84.8
|
30.5 U/L
Interval 22.5 to 72.5
|
|
Median Concentration of Aspartate Aminotransferase (AST)
time 48 hours
|
53.0 U/L
Interval 26.5 to 118.0
|
35.0 U/L
Interval 25.8 to 80.8
|
|
Median Concentration of Aspartate Aminotransferase (AST)
time 72 hours
|
56.5 U/L
Interval 29.3 to 100.3
|
44.0 U/L
Interval 28.0 to 97.5
|
SECONDARY outcome
Timeframe: baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrsAn enzyme normally present in liver and heart cells that is released into the bloodstream when the liver or heart is damaged. The blood ALT levels are elevated with liver damage (for example, from viral hepatitis) or with an insult to the heart (for example, from a heart attack). The normal range is 7 to 56 U/L.
Outcome measures
| Measure |
Simvastatin
n=29 Participants
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
n=24 Participants
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
|---|---|---|
|
Median Concentration of Alanine Aminotransferase (ALT)
baseline
|
23 U/L
Interval 18.5 to 28.0
|
22.0 U/L
Interval 17.5 to 28.5
|
|
Median Concentration of Alanine Aminotransferase (ALT)
time 0 hours
|
16.5 U/L
Interval 14.0 to 25.0
|
16.0 U/L
Interval 14.0 to 24.0
|
|
Median Concentration of Alanine Aminotransferase (ALT)
time 8 hours
|
18.0 U/L
Interval 13.0 to 23.0
|
16.5 U/L
Interval 12.3 to 21.0
|
|
Median Concentration of Alanine Aminotransferase (ALT)
time 24 hours
|
20.5 U/L
Interval 17.0 to 29.5
|
17.0 U/L
Interval 12.7 to 23.5
|
|
Median Concentration of Alanine Aminotransferase (ALT)
time 48 hours
|
23.0 U/L
Interval 16.5 to 42.0
|
18.0 U/L
Interval 14.8 to 25.0
|
|
Median Concentration of Alanine Aminotransferase (ALT)
time 72 hours
|
24.0 U/L
Interval 18.5 to 45.5
|
25.0 U/L
Interval 16.0 to 39.0
|
SECONDARY outcome
Timeframe: baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrsC-reactive protein (CRP) is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L.
Outcome measures
| Measure |
Simvastatin
n=29 Participants
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
n=24 Participants
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
|---|---|---|
|
Median Concentration of C-Reactive Protein (CRP)
baseline
|
3.0 mg/L
Interval 3.0 to 3.5
|
3.0 mg/L
Interval 3.0 to 4.2
|
|
Median Concentration of C-Reactive Protein (CRP)
time 0 hours
|
3.0 mg/L
Interval 3.0 to 3.2
|
3.0 mg/L
Interval 3.0 to 5.1
|
|
Median Concentration of C-Reactive Protein (CRP)
time 8 hours
|
3.0 mg/L
Interval 3.0 to 5.2
|
4.1 mg/L
Interval 3.0 to 8.0
|
|
Median Concentration of C-Reactive Protein (CRP)
time 24 hours
|
47.5 mg/L
Interval 22.8 to 70.6
|
52.5 mg/L
Interval 26.9 to 86.9
|
|
Median Concentration of C-Reactive Protein (CRP)
time 48 hours
|
139.7 mg/L
Interval 112.7 to 199.2
|
157.8 mg/L
Interval 96.0 to 258.2
|
|
Median Concentration of C-Reactive Protein (CRP)
time 72 hours
|
122.4 mg/L
Interval 100.3 to 173.1
|
197.2 mg/L
Interval 120.5 to 235.3
|
SECONDARY outcome
Timeframe: baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrsA creatine kinase test may be used to detect inflammation of muscles or muscle damage due to muscle disorders. A person may have muscle injury with few or nonspecific symptoms, such as weakness, fever, and nausea, that may also be seen with a variety of other conditions. A healthcare practitioner may use a CK test to help detect muscle damage in these cases, especially if someone is taking a drug such as a statin. Normal values at rest are usually between 60 and 174 IU/L.
Outcome measures
| Measure |
Simvastatin
n=29 Participants
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
n=24 Participants
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
|---|---|---|
|
Median Concentration of Creatine Kinase (CK)
baseline
|
89.5 U/L
Interval 58.5 to 112.5
|
111.0 U/L
Interval 86.0 to 154.2
|
|
Median Concentration of Creatine Kinase (CK)
time 0 hours
|
71.0 U/L
Interval 51.0 to 134.8
|
103.0 U/L
Interval 66.0 to 147.0
|
|
Median Concentration of Creatine Kinase (CK)
time 8 hours
|
527.0 U/L
Interval 213.0 to 754.0
|
257.0 U/L
Interval 206.8 to 558.0
|
|
Median Concentration of Creatine Kinase (CK)
time 24 hours
|
1345.0 U/L
Interval 434.5 to 2621.2
|
647.0 U/L
Interval 273.0 to 1688.0
|
|
Median Concentration of Creatine Kinase (CK)
time 48 hours
|
973.0 U/L
Interval 446.0 to 2724.0
|
685.0 U/L
Interval 272.0 to 1357.0
|
|
Median Concentration of Creatine Kinase (CK)
time 72 hours
|
597.0 U/L
Interval 355.0 to 1839.0
|
886.0 U/L
Interval 253.0 to 1565.0
|
SECONDARY outcome
Timeframe: baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrsInterleukin-6 (IL-6) may be used to help evaluate a person who has a condition associated with inflammation, such as lupus or rheumatoid arthritis, or with infection, such as sepsis. It may also be used in the evaluation of diabetes or cardiovascular disease. IL-6 is a cytokine, a protein produced by immune cells that acts on other cells to help regulate and/or promote an immune response. It also stimulates the production of acute phase reactants, proteins that increase in the blood with conditions that cause inflammation or tissue injury. Circulating IL-6 can be found in the blood of normal individuals in the 1 pg/mL range, with slight elevations during the menstrual cycle, modest elevations in certain cancers (melanoma) (10 pg/mL), and large elevations after surgery (30-430 pg/mL).
Outcome measures
| Measure |
Simvastatin
n=29 Participants
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
n=24 Participants
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
|---|---|---|
|
Median Concentration of Interleukin-6 (IL-6)
baseline
|
1.5 ng/ml
Interval 0.1 to 2.8
|
2.4 ng/ml
Interval 0.7 to 3.8
|
|
Median Concentration of Interleukin-6 (IL-6)
time 0 hours
|
1.2 ng/ml
Interval 0.1 to 2.3
|
1.8 ng/ml
Interval 0.5 to 3.4
|
|
Median Concentration of Interleukin-6 (IL-6)
time 8 hours
|
50.0 ng/ml
Interval 24.6 to 135.7
|
56.7 ng/ml
Interval 27.8 to 135.7
|
|
Median Concentration of Interleukin-6 (IL-6)
time 24 hours
|
64.2 ng/ml
Interval 41.5 to 182.4
|
70.2 ng/ml
Interval 51.9 to 172.7
|
|
Median Concentration of Interleukin-6 (IL-6)
time 48 hours
|
89.2 ng/ml
Interval 46.6 to 155.9
|
87.0 ng/ml
Interval 39.3 to 175.7
|
|
Median Concentration of Interleukin-6 (IL-6)
time 72 hours
|
37.7 ng/ml
Interval 16.3 to 55.5
|
45.2 ng/ml
Interval 22.0 to 92.4
|
SECONDARY outcome
Timeframe: baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrsTumor Necrosis Factor Alpha is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. TNF is important to the body because it helps regulate the response of the immune system to a foreign object, especially to the present cancerous tumor. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal. The normal range is 5 to 27.2 pg/ml.
Outcome measures
| Measure |
Simvastatin
n=29 Participants
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
n=24 Participants
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
|---|---|---|
|
Median Concentration of Tumor Necrosis Factor-Alpha (TNF)
baseline
|
1.0 pg/ml
Interval 0.7 to 1.2
|
0.85 pg/ml
Interval 0.6 to 1.3
|
|
Median Concentration of Tumor Necrosis Factor-Alpha (TNF)
time 0 hours
|
0.95 pg/ml
Interval 0.6 to 1.21
|
0.96 pg/ml
Interval 0.71 to 1.3
|
|
Median Concentration of Tumor Necrosis Factor-Alpha (TNF)
time 8 hours
|
0.94 pg/ml
Interval 0.64 to 1.34
|
0.86 pg/ml
Interval 0.54 to 1.06
|
|
Median Concentration of Tumor Necrosis Factor-Alpha (TNF)
time 24 hours
|
1.25 pg/ml
Interval 0.89 to 1.53
|
1.00 pg/ml
Interval 0.67 to 1.26
|
|
Median Concentration of Tumor Necrosis Factor-Alpha (TNF)
time 48 hours
|
1.57 pg/ml
Interval 1.05 to 1.7
|
1.37 pg/ml
Interval 0.89 to 1.63
|
|
Median Concentration of Tumor Necrosis Factor-Alpha (TNF)
time 72 hours
|
1.58 pg/ml
Interval 1.14 to 1.85
|
1.36 pg/ml
Interval 0.99 to 1.69
|
Adverse Events
Simvastatin
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simvastatin
n=29 participants at risk
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
n=24 participants at risk
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/29 • 72 hours after spine surgery
|
4.2%
1/24 • Number of events 1 • 72 hours after spine surgery
|
|
Cardiac disorders
Pulmonary embolism
|
0.00%
0/29 • 72 hours after spine surgery
|
4.2%
1/24 • Number of events 1 • 72 hours after spine surgery
|
|
Respiratory, thoracic and mediastinal disorders
Non-invasive ventilation required > 24 hrs post-op
|
3.4%
1/29 • Number of events 1 • 72 hours after spine surgery
|
4.2%
1/24 • Number of events 1 • 72 hours after spine surgery
|
Other adverse events
| Measure |
Simvastatin
n=29 participants at risk
Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
Placebo
n=24 participants at risk
Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
|
|---|---|---|
|
Gastrointestinal disorders
Post-op Ileus
|
0.00%
0/29 • 72 hours after spine surgery
|
4.2%
1/24 • Number of events 1 • 72 hours after spine surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place