Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
Each year, there are over 400,000 cardiac surgical operations performed in the United States;
of which 10,000 are performed on children. These operations are made possible by the use of
the heart-lung bypass machine, also known as cardiopulmonary bypass. This machine allows for
the body to be supported while the heart is repaired. While this machine has been life
saving, it has risks and can lead to a variety of complications.
One such complication results from the fact that the patient's blood is exposed to the
foreign material of the machine, such as plastic tubing. In nearly all cases of cardiac
surgery, this leads to a whole body response in the patient following the operation. This
response, inflammation, is characterized by alterations in the function of the heart and
lungs, fever, fluid retention, and bleeding disorders in the postoperative period. While this
is usually temporary and self limiting, significant morbidity occurs in approximately 1-2% of
cases where this inflammatory response is present. Additionally, children appear to be more
susceptible to this response. This can lead to significant postoperative complications that
are not associated with the actually surgical procedure performed on the heart.
The exact cause of this response is not fully understood. However, it is important to
understand the triggers, timing, and pattern of this complex inflammatory response in order
to modify or arrest it. Unlike other situations associated with this type of whole-body
inflammatory reaction such as trauma or overwhelming infection, cardiac surgical teams have
the advantage of knowing when the trigger will occur (i.e. during the cardiac operation) and
hence have the opportunity for preemptive intervention in an effort to minimize the response.
One such effort is the focus of this proposal.
Nitric oxide (NO) is a gas that has been used for years in the treatment of lung disease in
infants. It has been life saving and safe. Recently, it has been investigated for its
anti-inflammatory effects outside the lungs. We propose delivering NO to the source of the
greatest inflammation in cardiac surgery, the cardiopulmonary bypass machine. It is our
intention to show that in doing so; we can minimize the inflammation found in the first 24
hours following cardiac surgery in children. If we are correct, the reduction of this
inflammation will result in less damage to other organs of the child's body and improved
outcome following surgery.