Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heather Dickerson, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00590018
First received: December 28, 2007
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Cardiac Output, Low
Drug: Hydrocortisone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Blood pressure. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inotrope score. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: February 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjects in this arm will receive a 5 day tapering course of hydrocortisone.
Drug: Hydrocortisone
Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
Other Names:
  • Corticosteroids.
  • Steroids.
Placebo Comparator: 2
Subjects in this arm will receive 5 days of placebo.
Drug: Placebo
Placebo for 5 days intravenously.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590018

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Heather A Dickerson, MD Baylor College of Medicine
  More Information

Publications:
Responsible Party: Heather Dickerson, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00590018     History of Changes
Other Study ID Numbers: H-12030
Study First Received: December 28, 2007
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Congenital heart disease.
Low cardiac output syndrome.
Corticosteroids.
Hydrocortisone.
Blood pressure.
Inotropes.

Additional relevant MeSH terms:
Cardiac Output, Low
Critical Illness
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes
Cardiovascular Abnormalities
Congenital Abnormalities
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on July 24, 2014