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Impact of Pre-operative Steroids on Adrenal Insufficiency

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ClinicalTrials.gov Identifier: NCT02956707
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Santiago Borasino, MD, University of Alabama at Birmingham

Brief Summary:
Little is known regarding the incidence and clinical impact of AI in neonates during the acute postoperative period following separation from CPB. In a randomized control pilot study performed by the UAB CVICU research team, prophylactic post-CPB hydrocortisone infusions improved some postoperative outcomes, especially in those that acquired AI7. In an attempt to further explore post-CPB AI, a retrospective analysis of data from this study was performed. Of the 40 neonates included in the study, one-third (32.5%) developed AI following CPB (as determined by low-dose, 1 µg, cosyntropin stimulation test). Almost all of these subjects had normal response to cosyntropin stimulation pre-CPB. Subjects that developed AI demonstrated more hemodynamic instability, increased serum lactate and required more colloid resuscitation in the immediate post-CPB period in the operating room. Recent evidence has begun to highlight potential morbidity associated with perioperative steroid administration. Our cardiac surgery program is changing clinical practice and ceasing to give preoperative steroids to all patients (previously only neonatal CPB patients received preoperative methylprednisolone). With the possibility that preoperative steroid administration, and not CPB, primarily causes the high incidence of AI, it is prudent to further investigate the benefit and/or harm of perioperative steroid administration

Condition or disease Intervention/treatment
Adrenal Insufficiency Neonatal Other: No pre-operative steroids

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Pre-operative Steroids on Adrenal Insufficiency and Clinical Outcomes After Neonatal Cardiac Surgery With Cardiopulmonary Bypass
Actual Study Start Date : July 2016
Actual Primary Completion Date : January 12, 2019
Actual Study Completion Date : January 12, 2019


Group/Cohort Intervention/treatment
No pre-operative steroids

This is a prospectively enrolling group of 40 subjects.

Our current clinical practice has changed. We no longer administer pre-oeprative steroids to neonates undergoing surgery with cardiopulmonary bypass. These patients still receive their post-operative steroid infusion that starts after termination from bypass. This is their standard of care and does not change due to study enrollment.

Subject's enrolled in this trial have a ACTH stimulation test performed: pre-operative, immediately post-cardiopulmonary bypass prior to the initiation of their clinical steroids, and prior to leaving the cardiac intensive care unit.

Other: No pre-operative steroids
Due to new information provide from previous studies at our center the investigator instituted a clinical practice change remove steroid administration in the pre-operative period for all neonates undergoing surgery with cardiopulmonary bypass. This study is to evaluate this change.

Pre-operative steroids
This is a retrospective group of 40 subjects who were previously administered pre-operative steroids. These subjects also had ACTH testing performed pre-operative and immediately post-separation from cardiopulmonary bypass.



Primary Outcome Measures :
  1. Incidence of AI in neonates who do not receive preoperative methylprednisolone [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Hemodynamic parameters-Heart rate [ Time Frame: 1.5 hours post-CPB ]
    hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure-heart rate

  2. Hemodynamic parameters- Blood pressure [ Time Frame: 1.5 hours post-CPB ]
    hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure systolic blood pressure

  3. Hemodynamic parameters- Central venous pressure [ Time Frame: 1.5 hours post-CPB ]
    hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure central venous pressure

  4. Hemodynamic parameters- Flank Near infrared spectroscopy [ Time Frame: 1.5 hours post-CPB ]
    hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure flank near infrared spectroscopy.

  5. Hemodynamic parameters- cerebral near infrared spectroscopy [ Time Frame: 1.5 hours post-CPB ]
    hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure cerebral near infrared spectroscopy.

  6. Laboratory values- lactacte [ Time Frame: 1 week post-CPB ]
    serum lactate

  7. Laboratory values- Hematocrit [ Time Frame: 1 week post-CPB ]
    hematocrit

  8. Laboratory values- hemoglobin [ Time Frame: 1 week post-CPB ]
    hemoglobin

  9. Laboratory values- Mixed venous [ Time Frame: 1 week post-CPB ]
    mixed venous oxygen saturation

  10. Laboratory values- carbon dioxide [ Time Frame: 1 week post-CPB ]
    veno-arterial carbon dioxide difference is the carbon dioxide from the venous blood gas minus the carbon dioxide from the arterial blood gas.

  11. Laboratory values- oxygen content [ Time Frame: 1 week post-CPB ]
    arterial and venous oxygen content is the saturation from the arterial blood gas and the saturation from the venous blood gas

  12. Colloid/blood product volumes administered in the cardiovascular operating room [ Time Frame: intraoperative period ]
    volume in mililiters of crystalloids and colloids (albumin, fresh frozen plasma, packed red blood cells, and platelets) administered in the operating room

  13. Inotrope infusion doses [ Time Frame: 48 hours post-CPB ]
    incidence of low cardiac output syndrome based on inotropic support requirement in the post-operative period

  14. Inflammatory cytokines [ Time Frame: 48 hours post-CPB ]
    plasma will be collected and sent for inflammatory cytokine analysis at the following time points: pre-operative, 0 hour, 4 hour, 24 hour, and 48 hour post-cardiopulmonary bypass

  15. ACTH stimulation test [ Time Frame: 14 days post-CPB ]

    ACTH testing will be performed preoperative, immediately post-CPB, and prior to CICU discharge. This testing includes the following:

    Baseline ACTH and cortisol levels, administration of cosyntropin, 30 minutes post-cosyntropin cortisol level



Biospecimen Retention:   Samples With DNA
As a separate portion to this study consenting subject's legally authorized representative can provide consent to allow specimens to be stored for future research related to heart disease. These specimens include: blood (cell pellet and plasma), urine, and peritoneal dialysis fluid (if applicable).


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Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Neonates less than 30 days old undergoing cardiac surgery with cardiopulmonary bypass who do not receive pre-operative steroid administration as part of their standard of care medical management.
Criteria

Inclusion Criteria:40 consecutive neonates (≤30 days of age) with complex congenital heart disease undergoing cardiac surgery with CPB who will not be given preoperative steroids.

- Controls: 40 neonates with complex congenital heart disease undergoing cardiac surgery with CPB who received two doses of preoperative methylprednisolone (10mg/kg at eight hours and one hour prior to their operation). Data from this cohort has already been prospectively collected during the original pilot randomized control trial. Based on our clinical data over the past 8 years, the demographic and risk factors of the two cohorts will be very similar.

Exclusion Criteria: Neonates who do not require CPB during cardiac surgery or fail to separate from CPB in the operating room.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956707


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Santiago Borasino, MD, Interim Director Pediatric Cardiac Critical Care, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02956707     History of Changes
Other Study ID Numbers: F160616001
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: On de-identified study data will be published
Keywords provided by Santiago Borasino, MD, University of Alabama at Birmingham:
neonates
cardiopulmonary bypass
adrenal insufficiency
congenital heart disease
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents