An Intervention to Reduce Delirium After Cardiac Surgery
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Neurology, Psychiatric |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 8/12/2016 |
| Start Date: | June 2014 |
| End Date: | December 2015 |
Patients that have cardiac surgery may suffer from unrecognized cerebral ischemia or loss of
blood flow to the brain temporarily during surgery. This temporary loss of blood flow to the
brain may result in a condition called delirium. Delirium is a type temporary confusion.
There are some strategies that can help reduce cerebral ischemia during cardiac surgery
which can help lead to a reduction in the incidence of delirium. The investigator believes
that a strategy called remote ischemic preconditioning will help to reduce the incidence of
delirium incidence after cardiac surgery.
Remote ischemic preconditioning is a brief exposure to ischemia. This brief exposure to
ischemia occurs in an area of the body that is not undergoing a procedure. This brief
exposure to ischemia is not long enough to cause any damage to the body and it has been
demonstrated to help protect against more severe ischemic injury that may occur later during
surgery. In this study the investigator will use remote ischemic preconditioning to see if
it can reduce the incidence delirium after cardiac surgery.
blood flow to the brain temporarily during surgery. This temporary loss of blood flow to the
brain may result in a condition called delirium. Delirium is a type temporary confusion.
There are some strategies that can help reduce cerebral ischemia during cardiac surgery
which can help lead to a reduction in the incidence of delirium. The investigator believes
that a strategy called remote ischemic preconditioning will help to reduce the incidence of
delirium incidence after cardiac surgery.
Remote ischemic preconditioning is a brief exposure to ischemia. This brief exposure to
ischemia occurs in an area of the body that is not undergoing a procedure. This brief
exposure to ischemia is not long enough to cause any damage to the body and it has been
demonstrated to help protect against more severe ischemic injury that may occur later during
surgery. In this study the investigator will use remote ischemic preconditioning to see if
it can reduce the incidence delirium after cardiac surgery.
Delirium is common after cardiac surgery, occurring in 45-55% of patients, and is
independently associated with increased postoperative complications, reduced functional
capacity, cognitive decline, and increased mortality. Although the pathophysiology of
delirium is unclear, a leading hypothesis is that delirium results from unrecognized
cerebral ischemia during surgery. In preliminary data from the investigators group, delirium
was reduced in patients randomized to optimal blood pressure control during cardiopulmonary
bypass, using novel technology that determines an individual patient's lower limit of
cerebral autoregulation. Thus, patients undergoing cardiac surgery may suffer from
unrecognized cerebral ischemia that contributes to delirium, and strategies to attenuate the
effects of cerebral ischemia may reduce the incidence of delirium.
Ischemic preconditioning represents a novel strategy to attenuate the effects of cerebral
ischemia during cardiac surgery. Exposure to a brief period of ischemia, below the threshold
for tissue injury, has been demonstrated to protect against the harmful effects of a
subsequent more severe ischemic insult, in both animal and human studies. The protection
provided by ischemic preconditioning may also be effective when the preconditioning is
applied to a location remote from the organ of interest (i.e. a limb). Recently, a large
randomized trial in patients undergoing cardiac surgery demonstrated a survival benefit
among patients randomized to remote ischemic preconditioning vs. placebo. Remote ischemic
preconditioning was achieved by simple inflation of a blood pressure cuff to supra-systolic
pressures for 5 minutes, repeated for 3 cycles. However, neurological outcomes were not
assessed in this trial, although animal models support potential neurological protection
following remote ischemic preconditioning.
In this study the investigator will examine whether remote ischemic preconditioning can
reduce delirium, functional decline, and biomarkers of cerebral injury after cardiac
surgery. The investigator will explore the mechanism of preconditioning by examining
proteomic analyses in a subset of patients. These results will provide data to support an
NIH trial to examine the protective effects of remote ischemic preconditioning in cardiac
surgery, identify potential mechanisms of action and potential targets for therapeutic
pharmacologic interventions.
independently associated with increased postoperative complications, reduced functional
capacity, cognitive decline, and increased mortality. Although the pathophysiology of
delirium is unclear, a leading hypothesis is that delirium results from unrecognized
cerebral ischemia during surgery. In preliminary data from the investigators group, delirium
was reduced in patients randomized to optimal blood pressure control during cardiopulmonary
bypass, using novel technology that determines an individual patient's lower limit of
cerebral autoregulation. Thus, patients undergoing cardiac surgery may suffer from
unrecognized cerebral ischemia that contributes to delirium, and strategies to attenuate the
effects of cerebral ischemia may reduce the incidence of delirium.
Ischemic preconditioning represents a novel strategy to attenuate the effects of cerebral
ischemia during cardiac surgery. Exposure to a brief period of ischemia, below the threshold
for tissue injury, has been demonstrated to protect against the harmful effects of a
subsequent more severe ischemic insult, in both animal and human studies. The protection
provided by ischemic preconditioning may also be effective when the preconditioning is
applied to a location remote from the organ of interest (i.e. a limb). Recently, a large
randomized trial in patients undergoing cardiac surgery demonstrated a survival benefit
among patients randomized to remote ischemic preconditioning vs. placebo. Remote ischemic
preconditioning was achieved by simple inflation of a blood pressure cuff to supra-systolic
pressures for 5 minutes, repeated for 3 cycles. However, neurological outcomes were not
assessed in this trial, although animal models support potential neurological protection
following remote ischemic preconditioning.
In this study the investigator will examine whether remote ischemic preconditioning can
reduce delirium, functional decline, and biomarkers of cerebral injury after cardiac
surgery. The investigator will explore the mechanism of preconditioning by examining
proteomic analyses in a subset of patients. These results will provide data to support an
NIH trial to examine the protective effects of remote ischemic preconditioning in cardiac
surgery, identify potential mechanisms of action and potential targets for therapeutic
pharmacologic interventions.
Inclusion Criteria:
- ≥65 years old
- Undergoing coronary artery bypass and/or valve surgery
Exclusion Criteria:
- Mini mental state exam < 23
- Delirium at baseline
- Inability to speak and understand English
- Severe hearing impairment, resulting in inability to converse
- Planned use of intraoperative ketamine
- Inability to place or tolerate upper extremity tourniquet
- Hemoglobinopathy (e.g. sickle cell disease)
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