Who can participate?
Infants, children and teens up to 17 years old who are having heart surgery (in the Cardiac Intensive Care Unit, or CICU, at Cincinnati Children’s) may be eligible to participate.
Anyone who has had steroids in a month before heart surgery (pre-operative steroids are ok) or who has had the medication vasopressin 24 hours before heart surgery will not be able to participate in this research study.
What will happen in the study?
The research team will describe the study to you in detail, including the procedures, benefits and risks, and will be sure all your questions are answered. If you agree to take part, you will sign the consent permission form. If your child is 11 years or older, he/she will be asked to sign an assent permission form.
If your child qualifies and you decide you want him/her to be in the study, participation will last for about 48 hours following heart surgery. After 48 hours, no additional procedures or data will be collected for the study.
These are the things that will happen to your child while in the research study:
- Blood Samples: the research team will collect some blood from an IV line already in place for your child’s standard care (there will not be any extra needle sticks to collect blood for the research)
- Oxygen (VO2) Measurement: your child will be connected to a ventilator after surgery which will have a specialized machine connected to it allowing us to measure how much oxygen his/her body uses (this will not affect standard respiratory care or change the oxygen level)
- Review of Medical Record: the research team will collect data from your child’s medical records including his/her demographics (DOB, age, gender, weight, etc.), vital signs, diagnosis, and other information surrounding heart surgery
Vasopressin will only be administered to your child if he/she needs it per clinical care as standard procedure. If your child’s clinical condition does not require treatment with vasopressin after surgery, then he/she will not receive it. However, the research team will still perform the research procedures as described above.
If clinical care indicates that any of the research procedures above should not be done, they will not be performed.
If your child does receive vasopressin, the research team will collect blood samples before he/she receives the vasopressin and again 1, 2, 3, 6 and 12 hours after receiving vasopressin. Blood will also be collected 12, 24, and 48 hours following surgery. If your child does not receive vasopressin, the research team will only collect blood when he/she is admitted to the CICU and again at 12, 24, and 48 hours following surgery.
In total (research and clinical combined), we will collect about 2 teaspoons of blood for participants not receiving vasopressin and about 4 teaspoons for participants receiving vasopressin.
The VO2 measurements will be taken before your child starts treatment with vasopressin. If your child does receive vasopressin, the research team will also take additional VO2 measurements at 1, 3, 6 and 12 hours after he/she starts vasopressin. If your child does not receive vasopressin, the measurements will be taken at 12, 24, and 48 hours after surgery. If your child is extubated, or depending on the timing the vasopressin is given, your child may not have the VO2 measurements performed.
What are the good things that can happen from this research?
This study is considered ‘observational’, which means the research team is not administering any treatment or therapy for the purpose of the research.
Being in this study may not help your child right now. However, your child may benefit from increased blood pressure monitoring. When we finish the study, we hope to know more about vasopressin and its effect on other body systems. This may help other children with low blood pressure after cardiac surgery in the future.
Your child will receive the standard care for his/her surgery and CICU stay regardless of whether he/she takes part in the study.
What are the bad things that can happen from this research?
There is minimal risk from taking part in the study.
Measurement for oxygen consumption (VO2) does not carry any complications for patients that are already on mechanical ventilation.
Blood will be drawn only from IV lines already in place for standard care. No additional IVs, central lines, or needle sticks will take place for the research study. Your child will have his/her blood levels watched closely and may receive blood transfusions as part of the standard care following heart surgery, so the additional blood collected for research is not expected to pose additional risk.
There is the potential for loss of confidentiality of your child’s protected health information. We will take measures to prevent disclosure of information to unauthorized individuals as described below.
All possible risks will be discussed with parents and/or participants if interested in learning more about the study.