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Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

NCTNCT01595386 (opens ClinicalTrials.gov in a new tab)Other idPostop Steroids after CPB
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures ACTH (corticotropin), does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Not applicable
Enrollment
40 participants (actual)
Sponsor
University of Alabama at Birmingham · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Apr 2012
Primary completion
Nov 2013
Completion
Nov 2013
First posted
10 May 2012 (estimated)
Last update posted
10 Nov 2015 (estimated)
Conditions
Heart Disease Congenital Complex

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. N/A

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

    NCT01595386

    Apr 2012 to Nov 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • HydrocortisoneDrug
  • Normal SalineDrug

Arms2

  • Placebo comparator

    Normal Saline

    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.

  • Experimental

    Hydrocortisone

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of Low Cardiac Output Syndrome (LCOS)

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

    Registry description

    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.

Secondary outcomes(10)

  1. Mean Number of Days Subjects Alive and Ventilator Free

    Time frame · up to 28 days post op

    Registry description

    Respiratory variables include such as alive, ventilator free days at 28 days post-op will be used as secondary outcome. The mean number of days subjects were live and ventilator free up to the 28 days after surgery.

  2. Hospital Length of Stay

    Time frame · Admit to CICU till hospital discharge, approximately 3 weeks

    Registry description

    The average length of hospital stay from the time the subject is admitted to the CICU post-op until they are discharged will be used as a secondary outcome.

  3. Changes in Baseline Inflammatory Mediators

    Time frame · 0, 4,12, 24, and 48 hours post bypass

    Registry description

    Changes in pre-op inflammatory mediators will be assessed at 0, 4, 12, 24 and 48 hours post bypass and used as a secondary outcome.

  4. Average Inotrope Score

    Time frame · first 48 hours post-op

    Registry description

    Average inotrope score over first 48 hours after Cardiac Intensive Care Unit admission was used as a secondary outcome. Inotrope Score is calculated based on the dose of inotropes currently infusing at a given time points. The formula for calculation is as follows: Epinephrine/Norepinephrine (mcg/kg/min) dose x100, plus Dopamine/Dobutamine (mcg/kg/min) dose x 1, plus Neosynephrine (mcg/kg/min) dose x10, plus Vasopressin (units/kg/hr) \[(dose x60)/10,000\] = Inotrope Score. Our institution does not include Milrinone in our inotrope score calculation because every patient receives a continuous infusion in the immediate post-operative period. The higher the inotrope score the more cardiac support the patient is requiring or the worse their cardiac function is becoming.

  5. Fluid Balance

    Time frame · 1st 48 hours post-op

    Registry description

    Hemodynamic variable such as total fluid balance within the first 48 hours post-op will be used as a secondary outcome. Fluid balance is a calculation of the overall fluid status for a given time period. The total input (fluid, medications, etc) that are given to a patient during a given time frame (24 hours) minus the total output (urine, stool, drainage, etc. ) that comes out of a patient during a given time frame.

  6. Changes in Baseline Arterial-venous Oxygen Saturation Difference

    Time frame · admit to the CICU

    Registry description

    Respiratory values such as changes in baseline arterial-venous oxygen saturation difference at admission to the pediatric cardiac intensive care unit will be used as a secondary outcome.

  7. Time Until First Extubation

    Time frame · Until discharge from hospital, approximately 2 weeks

    Registry description

    Respiratory values such as duration of intubation will be used as a secondary outcome.

  8. CICU Length of Stay

    Time frame · approximately 1 week

    Registry description

    CICU length of stay will be calculated from the time the subject is admitted to the CICU post-op until they are discharged from the unit. This will be used as a secondary outcome.

  9. Mortality

    Time frame · Duration of CICU stay, approximately 1 week

    Registry description

    Subject mortality will in the CICU will be used as a secondary outcome.

  10. ACTH Stimulation Test

    Time frame · 24 hours prebypass and 0 hours post-bypass

    Registry description

    AdrenoCorticoTropic Hormone stimulation test will be performed at least 24 hours pre-bypass and immediately after successful discontinuation of bypass and compared. These outcomes will be used as a secondary outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Incidence of Low Cardiac Output Syndrome (LCOS)

GroupValue (percentage of patients)
Normal Saline-Placebo57
Hydrocortisone26
Secondary and other outcome results(7)
Secondary outcomeMedian· up to 28 days post op

Mean Number of Days Subjects Alive and Ventilator Free

GroupValue (days)
Normal Saline-Placebo24
Hydrocortisone25
Secondary outcomeMedian· Admit to CICU till hospital discharge, approximately 3 weeks

Hospital Length of Stay

GroupValue (days)
Normal Saline-Placebo13.5
Hydrocortisone19
Secondary outcomeMedian· 0, 4,12, 24, and 48 hours post bypass

Changes in Baseline Inflammatory Mediators

GroupValue (pg/mL)
Normal Saline-Placebo4
Hydrocortisone4.3
Secondary outcomeMedian· first 48 hours post-op

Average Inotrope Score

GroupValue (Inotrope Score)
Normal Saline-Placebo5.3
Hydrocortisone4.7
Secondary outcomeMedian· 1st 48 hours post-op

Fluid Balance

GroupValue (mL/kg)
Normal Saline-Placebo-64
Hydrocortisone-114
Secondary outcomeMedian· admit to the CICU

Changes in Baseline Arterial-venous Oxygen Saturation Difference

GroupValue (percentage of arterial-venous saturation)
Normal Saline-Placebo14
Hydrocortisone9.5
Secondary outcomeMedian· Until discharge from hospital, approximately 2 weeks

Time Until First Extubation

GroupValue (hours)
Normal Saline-Placebo55
Hydrocortisone51

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Normal Saline-PlaceboThe subjects will receive a bolus after successful completion of bypass and the post-pump 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. Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm.–3 / 2119 / 21
HydrocortisoneSubjects 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. Hydrocortisone: 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.–1 / 1917 / 19

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 1 Day up to 28 Days
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. 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 2. Successfully weaned off cardiopulmonary bypass after cardiac surgery Exclusion Criteria: 1. requirement for extracorporeal membrane oxygenation (ECMO) in the operating room 2. Known immune deficiency 3. Having previously received systemic steroids (except for two routine preoperative doses) 4. A current signed Do not resuscitate (DNR) or limitation of care order 5. Current enrollment in another interventional clinical study 6. Refusal of parental consent 7. Previous diagnosis of adrenal insufficiency 8. \> 28 days old at time of surgery whose repair dose not require CPB

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