Official Title: “Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Hydrocortisone
  • Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
• Drug: Placebo
  • Placebo for 5 days intravenously.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Subjects in this arm will receive a 5 day tapering course of hydrocortisone.
• Placebo Comparator: 2
  • Subjects in this arm will receive 5 days of placebo.

Primary Measures

• Blood pressure.
  • Time Frame: 10 days
    Safety Issue?: No

Secondary Measures

• Inotrope score.
  • Time Frame: 10 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 1 Month

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Baylor College of Medicine

Overall Clinical Trial Officials and Contacts

Heather A Dickerson, MD Principal Investigator Baylor College of Medicine  

Overall Contact: Heather A Dickerson, MD 832-826-5637 had@bcm.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00590018

Study ID Number: H-12030

ClinicalTrials.gov Identifier: NCT00590018

Health Authority: United States: Institutional Review Board