Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease
Condition: Cardiac Output, Low
MeSH terms: Heart Diseases; Heart Defects, Congenital; Cardiac Output, Low
Intervention: Hydrocortisone; Placebo
Intervention description: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.; Placebo for 5 days intravenously.
Intervention MeSH terms: Hydrocortisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 18.0
Sex: All
Maximum age: 1 Month
Healthy volunteers: No
Keywords: Congenital heart disease.; Low cardiac output syndrome.; Corticosteroids.; Hydrocortisone.; Blood pressure.; Inotropes.

Summary:

      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.
    

Eligibility criteria:

        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