Trial · NCT02361944

Risk of Oxygen During Cardiac Surgery Trial

NCT02361944, Phase 2, Phase 3, Completed, Vanderbilt University; results first posted 2023-08-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Risk of Oxygen During Cardiac Surgery Trial. Trials, record NCT02361944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02361944

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Risk of Oxygen During Cardiac Surgery Trial
NCT number: NCT02361944
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 213 participants, actual
Lead sponsor: Vanderbilt University
Conditions: Cardiac Surgery
Interventions: Oxygen - normoxia, Oxygen - hyperoxia
First posted: 2015-02-12
Last updated: 2024-02-01
Results first posted: 2023-08-14

Source ClinicalTrials.gov

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Intraoperative Systemic Oxidative Damage	separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)	quantified by measuring F2-isoprostanes isofurans following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting
Primary	Acute Kidney Injury	baseline to postoperative day 2	quantified by change in serum creatinine concentration
Secondary	Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation)	ICU admission (immediately after arrival in ICU from operating room)	brachial artery flow mediated dilation assessed when patient arrives in ICU after surgery. brachial artery flow mediated dilation is represented as the percent change in brachial artery diameter following 5 minutes of artery occlusion. The entire assessment takes place at ICU admission.
Secondary	Mitochondrial Function	up to 2 days following surgery	mitochondrial function in atrial myocardium estimated by quantifying adenylate kinase at the end of surgery and oxygen intervention
Secondary	Number of People With Arrhythmia	from surgery to hospital discharge, average of 6 days following surgery	defined as any atrial fibrillation following surgery until hospital discharge assessed using continuous telemetry, rhythm strips, and electrocardiograms
Secondary	Myocardial Injury or Infarction	morning of postoperative day 1	plasma concentration of creatine kinase, myocardial band
Secondary	Number of People With Stroke	from surgery to hospital discharge, average of 6 days following surgery	Defined as new deficit on neurologic exam and confirmed with radiologic evidence occurring at any point prior to hospital discharge
Secondary	Postoperative Cognitive Dysfunction	up to 18 months following surgery	Median change scores at the Short Blessed Scale (SBT) administered one-year following surgery. The SBT is a validated rating scale, administered by the clinician, measuring the cognitive performance. Sum Total (range 0-28) with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment.
Secondary	Respiratory Failure	from surgery to hospital discharge, average of 6 days following surgery	reintubation
Secondary	Chronic Kidney Disease	12 months following surgery	eGFR one year following surgery

1 to 10 of 33Source ClinicalTrials.gov

See all 33 registered outcomes

Outcomes33

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Intraoperative Systemic Oxidative Damage	separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)		pg/ml	MEDIAN
PRIMARY	Acute Kidney Injury	baseline to postoperative day 2		mg/dl	MEDIAN
SECONDARY	Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation)	ICU admission (immediately after arrival in ICU from operating room)		percentage change	MEDIAN
SECONDARY	Mitochondrial Function	up to 2 days following surgery	Analyzed in subjects with tissue available	Absorbance Units (AU)	MEDIAN
SECONDARY	Number of People With Arrhythmia	from surgery to hospital discharge, average of 6 days following surgery		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Myocardial Injury or Infarction	morning of postoperative day 1		ng/ml	MEDIAN
SECONDARY	Number of People With Stroke	from surgery to hospital discharge, average of 6 days following surgery		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Postoperative Cognitive Dysfunction	up to 18 months following surgery	Assessed in participants available for long-term follow-up who were able to complete cognitive assessments	score on a scale	MEDIAN
SECONDARY	Respiratory Failure	from surgery to hospital discharge, average of 6 days following surgery		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Chronic Kidney Disease	12 months following surgery	eGFR assessed in participants available for long-term follow-up	ml/min/1.73 meters squared	MEDIAN

1 to 10 of 33Source ClinicalTrials.gov

See all 33 outcomes

Results by group66

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Intraoperative Systemic Oxidative Damage	Normoxia	69	Inter-Quartile Range 54 to 89	pg/ml
Intraoperative Systemic Oxidative Damage	Hyperoxia	83	Inter-Quartile Range 62 to 108	pg/ml
Acute Kidney Injury	Normoxia	-0.01	Inter-Quartile Range -0.16 to 0.19	mg/dl
Acute Kidney Injury	Hyperoxia	0.01	Inter-Quartile Range -0.12 to 0.19	mg/dl
Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation)	Normoxia	4.50	Inter-Quartile Range 1.22 to 8.12	percentage change
Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation)	Hyperoxia	4.71	Inter-Quartile Range 1.80 to 9.68	percentage change
Mitochondrial Function	Normoxia	1884	Inter-Quartile Range 1745 to 2236	Absorbance Units (AU)
Mitochondrial Function	Hyperoxia	1936	Inter-Quartile Range 1591 to 2078	Absorbance Units (AU)
Number of People With Arrhythmia	Normoxia	37		Participants
Number of People With Arrhythmia	Hyperoxia	46		Participants

1 to 10 of 66Source ClinicalTrials.gov

See all 66 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Normoxia	100
Overall Study	STARTED	Hyperoxia	101
Overall Study	COMPLETED	Normoxia	100
Overall Study	COMPLETED	Hyperoxia	100
Overall Study	NOT COMPLETED	Normoxia	0
Overall Study	NOT COMPLETED	Hyperoxia	1

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fever	Immune system disorders	Normoxia	9	100	9
other	Fever	Immune system disorders	Hyperoxia	6	100	6
other	Tachycardia	Cardiac disorders	Normoxia	5	100	5
other	Tachycardia	Cardiac disorders	Hyperoxia	8	100	8
other	Hypotension	Vascular disorders	Normoxia	29	100	29
other	Hypotension	Vascular disorders	Hyperoxia	25	100	25
other	Vasoplegia	Vascular disorders	Normoxia	34	100	34
other	Vasoplegia	Vascular disorders	Hyperoxia	28	100	28
other	Decreased cardiac output	Cardiac disorders	Normoxia	2	100	2
other	Decreased cardiac output	Cardiac disorders	Hyperoxia	5	100	5

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Normoxia	2	100
Total, all-cause mortality	Hyperoxia	0	100
Total, other adverse events	Normoxia	80	100
Total, other adverse events	Hyperoxia	80	100
Total, serious adverse events	Normoxia	8	100
Total, serious adverse events	Hyperoxia	11	100

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28651648	DERIVED	PubMed
39110454	DERIVED	PubMed
40673571	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01GM112871	Hyper-oxygenation, oxidative stress, and kidney injury following cardiac surgery	BILLINGS, FREDERIC TREMAINE	VANDERBILT UNIVERSITY MEDICAL CENTER	NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES	2015 to 2019

Source NIH RePORTER

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Normoxia vs Hyperoxia: Number of People With Arrhythmia	Trial comparisons
Normoxia vs Hyperoxia: Respiratory Failure	Trial comparisons
Normoxia vs Hyperoxia: Acute Brain Dysfunction (Delirium)	Trial comparisons
Normoxia vs Hyperoxia: deaths from any cause	Trial comparisons
Normoxia vs Hyperoxia: Acute Kidney Injury, According to KDIGO Criteria	Trial comparisons
Normoxia vs Hyperoxia: Number of People With Stroke	Trial comparisons
Normoxia vs Hyperoxia: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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