Cardiac SurgeryNCT01539382
Measuring and Treating Brain Oxygen Levels in Open Heart Surgery
A study testing Cerebral oxygenation intervention in people with Cardiac Surgery, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to test whether keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery improves recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Cerebral oxygenation intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled to undergo elective cardiac or thoracic aortic surgery requiring cardiopulmonary bypass
Who cannot join
- Severe preoperative cognitive impairment (i.e., dementia or developmental intellectual disability)
- Sensory or motor impairment that would preclude reliable operation of a computer and keyboard
- Lack of access to use computer-based cognitive evaluation
- Non-English speaking patients
- Renal failure requiring dialysis
- Respiratory failure requiring home oxygen use
- Child's B or C hepatic failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Optimizing Cerebral Oxygenation in Cardiac Surgery
The purpose of this study is to test whether keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery improves recovery.
Hypothesis 1: keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery improves cognitive and neurological outcomes after cardiac and aortic surgery.
Read more
Hypothesis 2: keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery helps reduce major organ problems after cardiac and aortic surgery.
To test our hypotheses, the investigators will conduct a randomized control trial. Patients will be randomly assigned to one of two possible study groups. In the Treatment Group, the brain oxygen level will be watched by doctors and used to guide care in the operating room and the first day in the intensive care unit after surgery. Doctors will try to keep the brain oxygen level in a normal range by adjusting your blood pressure, carbon dioxide and blood acidity levels, and blood count. In the Control Group, the doctors will not be aware of the brain oxygen level unless it falls below a level that may be dangerous. If a patient's brain oxygen falls below such a level, the doctors will adjust the blood pressure, carbon dioxide and blood acidity levels, and blood count to increase the brain oxygen level. All other procedures will be part of regular medical care and will be performed according to the standard of care.
Read the detailed description
Background
There is a high incidence of cognitive dysfunction, neurological dysfunction, and multi-system organ dysfunction syndrome following cardiac surgery. There is preliminary evidence that optimization of cerebral oxygenation is associated with improved neurological and clinical outcomes.
Cerebral oximetry using near infrared spectroscopy (NIRS) is based on the ability of near-infrared light to penetrate scalp and skull, and its differential intracranial absorbance by oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb). Cerebral oximetry measures regional cerebral tissue oxygen saturation (SctO2) at the microvascular level (arterioles, venules, and capillaries) and provides information on the availability of oxygen in brain tissue. Unlike digital pulse oximetry, SctO2 reflects regional cerebral metabolism and the regional balance of cerebral oxygen supply and demand. NIRS SctO2 is the most promising monitoring technology for the purpose of guiding interventions targeted to improve brain and other organ preservation. The reasons for this include: (1) SctO2 is continuous, non-invasive, and available at the point of care; and (2) SctO2 is a sensitive index of cerebral hypoxia and/or cerebral ischemia, which are the main causes of brain injury in clinical settings. The preliminary work of Murkin strongly suggests that optimizing tissue perfusion using protocol-based treatments that optimize SctO2 decrease end-organ dysfunction in cardiothoracic surgical patients.
Recruitment Methods
Potential subjects are patients who are planned to undergo elective cardiac surgery at Mount Sinai Hospital. Potential subjects will be identified by checking the pre-admission schedule f or cardiothoracic surgery on a daily basis. Patients will be recruited at the surgical pre-admission screening; written informed consent will be obtained.
Risks to Subjects
Cerebral oximetry and computerized neurocognitive testing pose no known risk of harm to subjects.
Cerebral oximetry is an evolving technology that is not currently or imminently becoming a standard of care in monitoring for cardiothoracic surgical patients. The expense and the lack of outcome data make this a discretionary monitoring technology that is advocated by some, but that is not incorporated into any evidence-based guidelines or practice parameters. Therefore, compared with the existing standards of care, patients are not exposed to additional risk by withholding cerebral oximetry information from the practitioners.
Interventions to maintain cerebral oximetry above threshold values could be potentially injurious (e.g., initiating a red blood cell transfusion when it would not otherwise be given), however, any potential risk that is imparted by the interventions to maintain cerebral oximetry values are justified by the benefits of averting low or very low period of cerebral oximetry within the context of this research protocol.
- Conditions
- Cardiac Surgery
- Being tested
- Cerebral oxygenation intervention
- Keywords
- cardiac surgery, neurocognitive assessment, neurocognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oxygenation interventionProcedure or surgery
Also called Intervention
The protocol for interventions to increase cerebral oxygenation levels above 60% optimizing pH, PaO2, PaCO2, bispectral index, central venous pressure, mean arterial pressure, venous oxygen saturation, and hematocrit. In addition, cerebral perfusion pressure of 70-80 mm Hg and flow >2.0 l/min/m2 will be maintained during cardiopulmonary bypass. In the ICU, temperatures will be maintained below 38 degrees by administering antipyretics or cooling, and dexmedetomidine will be used if the patient is agitated.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral oxygenation intervention | Experimental | Cerebral oxygenation levels for people in this group will be monitored and maintained above 60%. If levels decrease to below 60%, a protocol is followed to guide possible interventions to increase cerebral oxygenation levels above 60% Receives: Procedure: Cerebral oxygenation intervention |
| Cerebral oxygenation control | No intervention | Cerebral oxygenation levels for people in this group will be masked and thus doctors and care staff will not use the cerebral oxygenation levels to make any interventions. If the cerebral oxygenation levels drop to below 40%, the cerebral oxygenation levels will be unmasked so that doctors can follow the protocol to increase levels to above 60%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative neurocognitive decline
Postoperative cognitive deficit as defined as negative changes in Z-score of greater than or equal to 1.0 in any of the four neurocognitive domains tested by neurocognitive assessment (Response Speed, Processing Speed, Attention, and Memory).
Measured: Baseline (before surgery)
Postoperative neurocognitive decline
Postoperative cognitive deficit as defined as negative changes in Z-score of greater than or equal to 1.0 in any of the four neurocognitive domains tested by neurocognitive assessment (Response Speed, Processing Speed, Attention, and Memory).
Measured: 3 months after surgery
Postoperative neurocognitive decline
Postoperative cognitive deficit as defined as negative changes in Z-score of greater than or equal to 1.0 in any of the four neurocognitive domains tested by neurocognitive assessment (Response Speed, Processing Speed, Attention, and Memory).
Measured: 6 months after surgery
Secondary outcomes (2)
Neurological dysfunction
Delirium, stroke with neurological deficit at hospital discharge, persistent vegetative state, or brain death.
Measured: During the hospitalization for postoperative recovery, average 8 days
Multiple organ dysfunction
Non-neurological postoperative organ dysfunction, defined as any of the following: intraoperative or non-neurological death within 1 year of surgery; ICU Length of Stay > 10 days; Acute Respiratory Distress Syndrome or respiratory failure > 5 days; need for renal replacement therapy; bilirubin > 3mg/dl, diagnosis of SIRS, sepsis, or DIC; multiple organ dysfunction syndrome (MODS), as defined by SOFA score > 5 at any time during ICU stay.
Measured: During the hospitalization for postoperative recovery, average 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muoi Trinh, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539382
- Sponsor's protocol ID
- GCO 11-0891
- Status last verified
- Oct 2015
- First submitted
- 21 Feb 2012
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cerebral Oxygenation in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01539382
- Acronym / sponsor ID
- GCO 11-0891
- Conditions
- Cardiac Surgery
- Keywords
- cardiac surgery, neurocognitive assessment, neurocognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery improves recovery.
Hypothesis 1: keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery improves cognitive and neurological outcomes after cardiac and aortic surgery.
Hypothesis 2: keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery helps reduce major organ problems after cardiac and aortic surgery.
To test our hypotheses, the investigators will conduct a randomized control trial. Patients will be randomly assigned to one of two possible study groups. In the Treatment Group, the brain oxygen level will be watched by doctors and used to guide care in the operating room and the first day in the intensive care unit after surgery. Doctors will try to keep the brain oxygen level in a normal range by adjusting your blood pressure, carbon dioxide and blood acidity levels, and blood count. In the Control Group, the doctors will not be aware of the brain oxygen level unless it falls below a level that may be dangerous. If a patient's brain oxygen falls below such a level, the doctors will adjust the blood pressure, carbon dioxide and blood acidity levels, and blood count to increase the brain oxygen level. All other procedures will be part of regular medical care and will be performed according to the standard of care.
Detailed description
Background
There is a high incidence of cognitive dysfunction, neurological dysfunction, and multi-system organ dysfunction syndrome following cardiac surgery. There is preliminary evidence that optimization of cerebral oxygenation is associated with improved neurological and clinical outcomes.
Cerebral oximetry using near infrared spectroscopy (NIRS) is based on the ability of near-infrared light to penetrate scalp and skull, and its differential intracranial absorbance by oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb). Cerebral oximetry measures regional cerebral tissue oxygen saturation (SctO2) at the microvascular level (arterioles, venules, and capillaries) and provides information on the availability of oxygen in brain tissue. Unlike digital pulse oximetry, SctO2 reflects regional cerebral metabolism and the regional balance of cerebral oxygen supply and demand. NIRS SctO2 is the most promising monitoring technology for the purpose of guiding interventions targeted to improve brain and other organ preservation. The reasons for this include: (1) SctO2 is continuous, non-invasive, and available at the point of care; and (2) SctO2 is a sensitive index of cerebral hypoxia and/or cerebral ischemia, which are the main causes of brain injury in clinical settings. The preliminary work of Murkin strongly suggests that optimizing tissue perfusion using protocol-based treatments that optimize SctO2 decrease end-organ dysfunction in cardiothoracic surgical patients.
Recruitment Methods
Potential subjects are patients who are planned to undergo elective cardiac surgery at Mount Sinai Hospital. Potential subjects will be identified by checking the pre-admission schedule f or cardiothoracic surgery on a daily basis. Patients will be recruited at the surgical pre-admission screening; written informed consent will be obtained.
Risks to Subjects
Cerebral oximetry and computerized neurocognitive testing pose no known risk of harm to subjects.
Cerebral oximetry is an evolving technology that is not currently or imminently becoming a standard of care in monitoring for cardiothoracic surgical patients. The expense and the lack of outcome data make this a discretionary monitoring technology that is advocated by some, but that is not incorporated into any evidence-based guidelines or practice parameters. Therefore, compared with the existing standards of care, patients are not exposed to additional risk by withholding cerebral oximetry information from the practitioners.
Interventions to maintain cerebral oximetry above threshold values could be potentially injurious (e.g., initiating a red blood cell transfusion when it would not otherwise be given), however, any potential risk that is imparted by the interventions to maintain cerebral oximetry values are justified by the benefits of averting low or very low period of cerebral oximetry within the context of this research protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral oxygenation intervention | Experimental | Procedure: Cerebral oxygenation interventionCerebral oxygenation levels for people in this group will be monitored and maintained above 60%. If levels decrease to below 60%, a protocol is followed to guide possible interventions to increase cerebral oxygenation levels above 60% |
| Cerebral oxygenation control | No intervention | –Cerebral oxygenation levels for people in this group will be masked and thus doctors and care staff will not use the cerebral oxygenation levels to make any interventions. If the cerebral oxygenation levels drop to below 40%, the cerebral oxygenation levels will be unmasked so that doctors can follow the protocol to increase levels to above 60%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled to undergo elective cardiac or thoracic aortic surgery requiring cardiopulmonary bypass
Key exclusion criteria (7 listed)
- Severe preoperative cognitive impairment (i.e., dementia or developmental intellectual disability)
- Sensory or motor impairment that would preclude reliable operation of a computer and keyboard
- Lack of access to use computer-based cognitive evaluation
- Non-English speaking patients
- Renal failure requiring dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral oxygenation interventionAlso: InterventionThe protocol for interventions to increase cerebral oxygenation levels above 60% optimizing pH, PaO2, PaCO2, bispectral index, central venous pressure, mean arterial pressure, venous oxygen saturation, and hematocrit. In addition, cerebral perfusion pressure of 70-80 mm Hg and flow >2.0 l/min/m2 will be maintained during cardiopulmonary bypass. In the ICU, temperatures will be maintained below 38 degrees by administering antipyretics or cooling, and dexmedetomidine will be used if the patient is agitated. | Procedure or surgery | Cerebral oxygenation intervention |
Primary outcome
Postoperative neurocognitive decline
Time frame: Baseline (before surgery)
Postoperative cognitive deficit as defined as negative changes in Z-score of greater than or equal to 1.0 in any of the four neurocognitive domains tested by neurocognitive assessment (Response Speed, Processing Speed, Attention, and Memory).
Postoperative neurocognitive decline
Time frame: 3 months after surgery
Postoperative cognitive deficit as defined as negative changes in Z-score of greater than or equal to 1.0 in any of the four neurocognitive domains tested by neurocognitive assessment (Response Speed, Processing Speed, Attention, and Memory).
Postoperative neurocognitive decline
Time frame: 6 months after surgery
Postoperative cognitive deficit as defined as negative changes in Z-score of greater than or equal to 1.0 in any of the four neurocognitive domains tested by neurocognitive assessment (Response Speed, Processing Speed, Attention, and Memory).
2 secondary outcomes
Neurological dysfunction
Time frame: During the hospitalization for postoperative recovery, average 8 days
Multiple organ dysfunction
Time frame: During the hospitalization for postoperative recovery, average 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muoi Trinh, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral oxygenation intervention in people with Cardiac Surgery, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative neurocognitive decline (time frame: Baseline (before surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.