search
Back to results

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

Primary Purpose

Cardiac Output, Low

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydrocortisone
Placebo
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Output, Low focused on measuring Congenital heart disease., Low cardiac output syndrome., Corticosteroids., Hydrocortisone., Blood pressure., Inotropes.

Eligibility Criteria

undefined - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Subjects in this arm will receive a 5 day tapering course of hydrocortisone.

Subjects in this arm will receive 5 days of placebo.

Outcomes

Primary Outcome Measures

Blood Pressure.
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 28, 2007
Last Updated
April 20, 2016
Sponsor
Baylor College of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT00590018
Brief Title
Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease
Acronym
Corti
Official Title
Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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, cardiopulmonary bypass/cross clamp/circulatory arrest times and inotrope requirements. Those in the treatment arm will be dosed with hydrocortisone - stress dose (100mg/m2/dose daily 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: heart rate, blood pressure, mixed venous oxygen saturation to assess cardiac output, blood cultures/infection/antibiotics (antibiotics as deemed necessary by the primary cardiologist), +/- gastrointestinal bleeding, time to discontinuing inotropic agents, time to extubation, length of intensive care unit 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, blood urea nitrogen/creatinine, complete blood counts, lactate, arterial blood gases, cultures and stool guaiac. The following labs will be assessed in addition to regular monitoring: cortisol, adrenocorticotropin hormone and C reactive protein.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, Low
Keywords
Congenital heart disease., Low cardiac output syndrome., Corticosteroids., Hydrocortisone., Blood pressure., Inotropes.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Subjects in this arm will receive a 5 day tapering course of hydrocortisone.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Subjects in this arm will receive 5 days of placebo.
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Other Intervention Name(s)
Corticosteroids., Steroids.
Intervention Description
Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 5 days intravenously.
Primary Outcome Measure Information:
Title
Blood Pressure.
Description
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).
Time Frame
2 days
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather A Dickerson, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16276331
Citation
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.
Results Reference
background
PubMed Identifier
33045104
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs