Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass

NCT01595386 | Completed Results DMC

• 1 other identifier: Postop Steroids after CPB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol is designed to offer insight into critical illness related corticosteroid insufficiency and steroid supplementation in neonates undergoing cardiac surgery with cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative period.

Conditions

Heart Disease Congenital Complex

Outcome Measures

Primary Outcomes (1)

• Incidence of Low Cardiac Output Syndrome (LCOS)

  Low Cardiac Output Syndrome (LCOS) within the first 48 hours after post-operative admission to the Pediatric Cardiac Intensive Care Unit was used as the primary outcome. This was defined as a double in inotropic support from post-operative admit, requiring Extracorporeal Membrane Oxygenation (ECMO) support, receiving Cardiopulmonary Resuscitation, or death.

  first 48 hours after cardiac intensive care unit (CICU) admission post-op

Secondary Outcomes (10)

• Mean Number of Days Subjects Alive and Ventilator Free

  up to 28 days post op

• Hospital Length of Stay

  Admit to CICU till hospital discharge, approximately 3 weeks

• Changes in Baseline Inflammatory Mediators

  0, 4,12, 24, and 48 hours post bypass

• Average Inotrope Score

  first 48 hours post-op

• Fluid Balance

  1st 48 hours post-op

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

The subjects will receive a bolus after successful completion of bypass and the post-pump adrenal corticotrophin hormone (ACTH) stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.

Drug: Normal Saline

Hydrocortisone

EXPERIMENTAL

Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.

Drug: Hydrocortisone

Interventions

Hydrocortisone DRUG

The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off.

Also known as: Solu Cortef

Hydrocortisone

Normal Saline DRUG

This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm.

Also known as: 0.9% Sodium Chloride

Normal Saline

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonate (\< 28 days old) undergoing correct cardiac surgery, or infants undergoing the following surgery procedures: Norwood, Arterial Switch, Total Anomalous Pulmonary Venous Return Repair, Interrupted Aortic Arch Repair, Truncus Arteriosus Repair
• Successfully weaned off cardiopulmonary bypass after cardiac surgery

You may not qualify if:

• requirement for extracorporeal membrane oxygenation (ECMO) in the operating room
• Known immune deficiency
• Having previously received systemic steroids (except for two routine preoperative doses)
• A current signed Do not resuscitate (DNR) or limitation of care order
• Current enrollment in another interventional clinical study
• Refusal of parental consent
• Previous diagnosis of adrenal insufficiency
• \> 28 days old at time of surgery whose repair dose not require CPB

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Interventions

Hydrocortisone; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

small, single-center trial; included subjects from more than one surgeon; all patients received preoperative and rescue steroids; definition of low cardiac output syndrome although appropriate must ultimately be arbitrary.

Results Point of Contact

• Title: Jeffrey Alten, M.D., Director of Clinical and Translational Research Department
• Organization: University of Alabama at Birmingham, Pediatric Cardiac Critical Care

jalten@peds.uab.edu

205-975-3123

Study Officials

• Jeffrey Alten, MD

  UAB Pediatric Critical Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor of Pediatrics, Medical Director of the UAB Pediatric Cardiac Intensive Care Unit

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: May 10, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 10, 2015
• Results First Posted: November 10, 2015

Record last verified: 2015-10

Locations

US (1)