Trial Outcomes & Findings for Inhibition of Lipid Peroxidation During Cardiac Surgery (NCT NCT01366976)

NCT ID: NCT01366976

Last Updated: 2015-01-27

Results Overview

Plasma isofuran concentrations as a measure of lipid peroxidation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2015-01-27

Participant Flow

Patients were enrolled by the research nurse at the time of the preoperative evaluation for surgery. The study period was from January 2012 until April 2013.

Patients were excluded for the following reasons: 1) allergy to acetaminophen, 2) evidence of severe hepatic impairment (history of liver cirrhosis or total bilirubin >2.0mg/dL) 3) evidence of impaired renal function (serum creatinine >2.0mg/dL) or 4) pregnancy.

Participant milestones

Measure	Acetaminophen IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period	Placebo Saline in equivalent volume as study drug
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhibition of Lipid Peroxidation During Cardiac Surgery

Baseline characteristics by cohort

Measure	Acetaminophen n=30 Participants IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period	Placebo n=30 Participants Saline in equivalent volume as study drug	Total n=60 Participants Total of all reporting groups
Age, Continuous	64.5 years n=5 Participants	61.0 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Plasma isofuran concentrations as a measure of lipid peroxidation

Outcome measures

Measure	Acetaminophen n=30 Participants IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period	Placebo n=30 Participants Saline infusion
Plasma Isofuran Concentrations baseline	61.5 pg/mL Standard Error 6.8	67.7 pg/mL Standard Error 5.97
Plasma Isofuran Concentrations 30min of bypass	72.1 pg/mL Standard Error 7.37	82.7 pg/mL Standard Error 6.02
Plasma Isofuran Concentrations 60min of bypass	83.4 pg/mL Standard Error 7.55	110.8 pg/mL Standard Error 13.21
Plasma Isofuran Concentrations post-bypass	82.9 pg/mL Standard Error 9.71	96.1 pg/mL Standard Error 8.22
Plasma Isofuran Concentrations ICU	85.3 pg/mL Standard Error 8.53	88.0 pg/mL Standard Error 8.81
Plasma Isofuran Concentrations postoperative day 1	70.4 pg/mL Standard Error 8.45	68.5 pg/mL Standard Error 6.21

PRIMARY outcome

Timeframe: 24 hours

Plasma F2-isoprostane concentrations as a measure of lipid peroxidation

Outcome measures

Measure	Acetaminophen n=30 Participants IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period	Placebo n=30 Participants Saline infusion
Plasma F2-isoprostane Concentrations baseline	27.8 pg/mL Standard Error 3.3	30.6 pg/mL Standard Error 3.5
Plasma F2-isoprostane Concentrations 30min of bypass	45.8 pg/mL Standard Error 3.7	49.1 pg/mL Standard Error 4.9
Plasma F2-isoprostane Concentrations 60min of bypass	52.0 pg/mL Standard Error 5.3	52.8 pg/mL Standard Error 6.0
Plasma F2-isoprostane Concentrations post-bypass	34 pg/mL Standard Error 2.9	48.4 pg/mL Standard Error 10.2
Plasma F2-isoprostane Concentrations ICU	32.0 pg/mL Standard Error 3.1	47.5 pg/mL Standard Error 9.9
Plasma F2-isoprostane Concentrations postoperative day 1	26.5 pg/mL Standard Error 2.9	26.0 pg/mL Standard Error 2.6

SECONDARY outcome

Timeframe: 24 hours

Changes in urinary NGAL (neutrophil gelatinase-associated lipocalin) as marker of acute kidney injury

Outcome measures

Measure	Acetaminophen n=30 Participants IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period	Placebo n=30 Participants Saline infusion
Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin) postoperative day 1	46.04 ng/mL Standard Error 25.5	16.8 ng/mL Standard Error 2.4
Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin) baseline	19.21 ng/mL Standard Error 6.7	23.2 ng/mL Standard Error 8.4
Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin) pos-bypass	145.8 ng/mL Standard Error 49.6	138.4 ng/mL Standard Error 43.5

SECONDARY outcome

Timeframe: 72 hours

Serum creatinine measured over a 72 hour period

Outcome measures

Measure	Acetaminophen n=30 Participants IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period	Placebo n=30 Participants Saline infusion
Serum Creatinine baseline	0.98 mg/dL Standard Error 0.04	0.94 mg/dL Standard Error 0.03
Serum Creatinine postoperative day 1	0.89 mg/dL Standard Error 0.04	0.90 mg/dL Standard Error 0.04
Serum Creatinine postoperative day 2	0.96 mg/dL Standard Error 0.04	0.96 mg/dL Standard Error 0.04
Serum Creatinine postoperative day 3	0.93 mg/dL Standard Error 0.04	0.88 mg/dL Standard Error 0.05

Adverse Events

Acetaminophen

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acetaminophen n=30 participants at risk IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period	Placebo n=30 participants at risk Saline infusion
Cardiac disorders Postoperative atrial fibrillation	13.3% 4/30 • Number of events 4 • Duration of hospitalization up to 2 weeks	13.3% 4/30 • Number of events 4 • Duration of hospitalization up to 2 weeks
Surgical and medical procedures Re-exploration for bleeding	3.3% 1/30 • Number of events 1 • Duration of hospitalization up to 2 weeks	3.3% 1/30 • Number of events 1 • Duration of hospitalization up to 2 weeks
Renal and urinary disorders Acute kidney injury	10.0% 3/30 • Number of events 3 • Duration of hospitalization up to 2 weeks	10.0% 3/30 • Number of events 3 • Duration of hospitalization up to 2 weeks

Additional Information

Mias Pretorius

Vanderbilt University School of Medicine

Phone: 16153220758

Email: mias.pretorius@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place