- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00590018
Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease (Corti)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Subjects in this arm will receive a 5 day tapering course of hydrocortisone.
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Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
Other Names:
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Placebo Comparator: 2
Subjects in this arm will receive 5 days of placebo.
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Placebo for 5 days intravenously.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure.
Time Frame: 2 days
|
Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration).
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration.
Time Frame: 2 days
|
Inotrope score: epinephrine (mcg/kg/min x 100) + norepinephrine (mcg/kg/min x 100) + phenylephrine (mcg/kg/min x 100) + dopamine (mcg/kg/min x1) + dobutamine (mcg/kg/min x 1) + milrinone (mcg/kg/min x15).
A lower inotrope score is better with the minimum being 0 and the maximum being 85.
|
2 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heather A Dickerson, MD, Baylor College of Medicine
Publications and helpful links
General Publications
- Gibbison B, Villalobos Lizardi JC, Aviles Martinez KI, Fudulu DP, Medina Andrade MA, Perez-Gaxiola G, Schadenberg AW, Stoica SC, Lightman SL, Angelini GD, Reeves BC. Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013101. doi: 10.1002/14651858.CD013101.pub2.
- Suominen PK, Dickerson HA, Moffett BS, Ranta SO, Mott AR, Price JF, Heinle JS, McKenzie ED, Fraser CD Jr, Chang AC. Hemodynamic effects of rescue protocol hydrocortisone in neonates with low cardiac output syndrome after cardiac surgery. Pediatr Crit Care Med. 2005 Nov;6(6):655-9. doi: 10.1097/01.pcc.0000185487.69215.29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-12030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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