Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | February 2003 |
| End Date: | December 2009 |
| Contact: | Heather A Dickerson, MD |
| Email: | had@bcm.edu |
| Phone: | 832-826-5637 |
Babies having heart surgery often have problems after surgery with their blood pressure and
getting enough blood to their bodies. To treat this they require medicines to keep their
blood pressure high enough to get blood to their bodies. The side effects of these
medicines include fast heart rates and increasing the amount of work the heart has to do.
Corticosteroids are made by the body and help to use the energy in the food people eat,
control the chemicals in their blood and maintain their blood pressure. Corticosteroids
made by the body may be decreased in patients that have major surgery. Corticosteroids help
to increase blood pressure and can decrease the amount of blood pressure medicines a patient
requires. Corticosteroids have been shown to increase blood pressure in patients with
bacterial infections and in very small, premature babies but have only been studied in a few
babies who have had heart surgery. The way corticosteroids work is unknown but may involve
decreasing the body's response to being on a heart-lung machine or give steroids not being
made by the patient.
Corticosteroids have been shown to be helpful in treating many diseases. The purpose of
this study is to look at the effects of corticosteroids in babies who have had heart surgery
and need blood pressure medicines in the intensive care unit after surgery. Our idea is
that getting corticosteroids will allow us to decrease the amount of blood pressure
medicines each patient needs and improve how they do after surgery. We also plan to do
blood tests to help determine how the corticosteroids are working.
It will be randomly determined if the subject receives corticosteroids or salt water. The
subject will receive a corticosteroid or salt water once a day for five days. Their vital
signs will be monitored, especially blood pressure and their need for medicines to increase
their blood pressure. Blood work will also be obtained to determine their body's ability to
make steroids.
The study will be prospective. Patients who meet entry criteria will be randomized to
receive corticosteroids versus placebo. Randomization will take into account biventricular
versus univentricular repairs/palliations and whether the patients received intraoperative
steroids. Patients will be compared with matched controls based on: diagnosis, +/-
intraoperative steroids/phenoxybenzamine, CPB/cross clamp/circulatory arrest times and
inotrope requirements. Those in the treatment arm will be dosed with hydrocortisone - stress
dose (100mg/m2/dose QD x2, then taper with two days at half the original dose and one day at
one quarter of the original dose) and then the steroids will be discontinued. Outcome data
will include: HR, BP, mVO2 to assess cardiac output, blood cultures/infection/antibiotics
(antibiotics as deemed necessary by the primary cardiologist), +/- GI bleeding, time to
discontinuing inotropic agents, time to extubation, length of ICU admission and survival.
Laboratory studies will be assessed before and 24 hours after the institution of steroids.
The following labs are standard of care in the unit and will be assessed: glucose,
electrolytes, BUN/Creatinine, CBC, lactate, ABG, cultures and stool guaiac. The following
labs will be assessed in addition to regular monitoring: cortisol, ACTH and CRP.
Inclusion Criteria:
- Age < 1 month
- Postoperative
- Inotrope score > 20 x > 4 hrs [epinephrine: (mcg/kg/min) x 100 + norepinephrine:
(mcg/kg/min) x 100 + phenylephrine: (mcg/kg/min) x 100 + vasopressin: (units/kg/hr) x
100 + milrinone: (mcg/kg/min) x 15 + dopamine: (mcg/kg/min) x 1 + dobutamine:
(mcg/kg/min) x 1 + calcium chloride: (mg/kg/hr) x 1]
Exclusion Criteria:
- Age > 1 month
- Documented sepsis
- Preoperative use of steroids > 1 wk
We found this trial at
1
site
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
Click here to add this to my saved trials
