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Oxygen - normoxia for Cardiac Surgery (ROCS Trial)
Phase 2 & 3
Waitlist Available
Led By Frederic T. Billings, IV, MD, MSc
Research Sponsored by Vanderbilt University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months following surgery
Awards & highlights
ROCS Trial Summary
This trial will compare the effects of different oxygen levels during surgery on postoperative organ injury.
ROCS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months following surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months following surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Kidney Injury
Intraoperative Systemic Oxidative Damage
Secondary outcome measures
Acute Brain Dysfunction (Delirium)
Acute Kidney Injury Estimated by Urine Concentration of NGAL
Acute Kidney Injury Estimated by Urine Concentration of TIMP-2 IGFBP7
+27 moreSide effects data
From 2021 Phase 2 & 3 trial • 213 Patients • NCT0236194448%
Anemia
47%
Leukocytosis
28%
Vasoplegia
25%
Hypotension
8%
Tachycardia
6%
Fever
5%
Category: Arrythmia, Pacemaker or Cardiac Arrest
5%
Decreased cardiac output
1%
Seizure
1%
Hypoxia
1%
right ventricular failure
1%
heparin-induced thrombocytopenia
1%
anaphylaxis
1%
Pleural effusion
1%
Thrombocytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hyperoxia
Normoxia
ROCS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NormoxiaExperimental Treatment1 Intervention
Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery.
Group II: HyperoxiaActive Control1 Intervention
Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxygen - normoxia
2016
Completed Phase 3
~220
Find a Location
Who is running the clinical trial?
National Institute of General Medical Sciences (NIGMS)NIH
271 Previous Clinical Trials
246,808 Total Patients Enrolled
Vanderbilt UniversityLead Sponsor
705 Previous Clinical Trials
6,143,210 Total Patients Enrolled
Frederic T. Billings, IV, MD, MScPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a heart surgery that required stopping your blood flow during the operation, such as a replacement of the aortic arch.You need extra oxygen before surgery to keep your blood oxygen level at 92% or higher.You are pregnant.You use oxygen at home.You had heart surgery that requires cutting open your chest.You have a specific heart condition called a "hole in the heart" that causes problems with blood flow.
Research Study Groups:
This trial has the following groups:- Group 1: Normoxia
- Group 2: Hyperoxia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are currently enrolled in the trial?
"This study is closed to new participants. However, if you are seeking other trials, there are 49 surgical studies and 25 cardiac trials that are actively enrolling patients."
Answered by AI
What medical conditions respond well to treatment with Oxygen - normoxia?
"Oxygen therapy, or normoxia, is a standard treatment for hypoxemia but can also improve symptoms in patients with anemia, malignancies, and sleep apnea."
Answered by AI
Can new patients still sign up for this experimental procedure?
"Unfortunately, this study is no longer enrolling patients. The trial was originally posted on April 5th, 2016 but has not been updated since October 27th, 2022. However, there are presently 49 trials actively recruiting patients for surgery and 25 trials for Oxygen - normoxia that are admitting participants."
Answered by AI
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