STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS)
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ClinicalTrials.gov Identifier: NCT03229538 |
Recruitment Status :
Recruiting
First Posted : July 25, 2017
Last Update Posted : July 17, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congenital Heart Disease in Children Inflammatory Response | Drug: Methylprednisolone Drug: Isotonic saline | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS) |
Actual Study Start Date : | October 18, 2017 |
Estimated Primary Completion Date : | July 28, 2021 |
Estimated Study Completion Date : | July 28, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Methylprednisolone Arm
IV Methylprednisolone
|
Drug: Methylprednisolone
IV Steroid pre-operative and intra-operative |
Placebo Comparator: Placebo Arm
IV Isotonic Saline
|
Drug: Isotonic saline
Isotonic saline pre-operative and intra-operative |
- A composite mortality, major morbidity and length of stay global rank endpoint with endpoints ranked according to severity. [ Time Frame: Until hospital discharge. Length of stay up to 6 months ]
A composite mortality, major morbidity and length of stay global rank endpoint with endpoints ranked according to severity.
For this endpoint each randomized patient will be assigned a rank based upon their most-severe outcome.
- Mortality including in-hospital mortality or mortality after hospital discharge but within 30 days of the last cardiac operation of the admission [ Time Frame: up to 30 days ]
- Death or major complication as previously defined and reported by the STS-CHSD registry. [ Time Frame: Until hospital discharge. Length of stay up to 6 months ]
- Post-operative hospital length of stay [ Time Frame: Until hospital discharge. Length of stay up to 6 months ]
- Prevalence of prolonged (>7days) mechanical ventilation [ Time Frame: Until hospital discharge. Length of stay up to 6 months ]
- Occurrence of post-operative low cardiac output syndrome. Based upon the STS-CHSD registry defined "cardiac dysfunction resulting in low cardiac output" complication variable [ Time Frame: Until hospital discharge. Length of stay up to 6 months ]
- Occurence of any one or more of the following STS-CHSD-defined major post-operative infectious complications: o Postprocedural infective endocarditis o Pneumonia o Sepsis o Deep wound infection o Mediastinitis [ Time Frame: Until hospital discharge. Length of stay up to 6 months ]
- Any other post-operative complications from the start of study drug administration until hospital discharge. [ Time Frame: Until hospital discharge. Length of stay up to 6 months ]
- PK/PD - Time to maximum concentration (Tmax) [ Time Frame: Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB) ]
- PK/PD - Maximum concentration (Cmax) [ Time Frame: Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB) ]
- PK/PD - Clearance (CL) [ Time Frame: Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB) ]
- PK/PD - Volume of distribution (Vd) [ Time Frame: Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB) ]
- Post-operative biomarkers of the inflammatory response to cardiopulmonary bypass including interleukins 6 and 8 [ Time Frame: Pre-2nd dose; a minimum of 2 of any of the following 5 time points (0-30 min after the start of CPB, 0-30 min after MUF, 1-2 hrs after CPB end, 4-6 hrs after CPB end, or 16-24 hrs after CPB end); and 36-48 hrs after CPB end ]Only to be collected at select centers and in those patients whose parent/legally authorized representative have granted consent to blood draws

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Ages Eligible for Study: | up to 12 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age < 1 year at the time of surgery
- Undergoing heart surgery with CPB as part of standard clinical care
- Availability and willingness of the parent/legally authorized representative to provide written informed consent
Exclusion Criteria:
- < 37 weeks adjusted gestational age at time of surgery
- Any oral or intravenous steroid treatment within two days of surgery
- Any patient receiving any of the following medications within 2 days of surgery:
Amphoteracin B, aminoglutethimide, anticholesterases, warfarin, P450 3A4 inducers including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, bosentan and nafcillin or P450 3A4 inhibitors including (but not limited to) clarithromycin, voriconazole, itraconazole, ketoconazole, ciprofloxacin, diltiazem, fluconazole, erythromycin and verapamil.
- Infection contraindicating steroid use
- Preoperative mechanical circulatory support or active resuscitation at the time of randomization
- Emergent surgery precluding steroid administration 8-12 hours before surgery

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): NCT03229538
Contact: Project Leader | 9196681080 | dcri-STRESS@duke.edu |

Principal Investigator: | Kevin Hill | Duke University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kevin Hill, Associate Professor of Pediatrics, Duke University |
ClinicalTrials.gov Identifier: | NCT03229538 |
Other Study ID Numbers: |
Pro00078106 1U01TR001803-01 ( U.S. NIH Grant/Contract ) |
First Posted: | July 25, 2017 Key Record Dates |
Last Update Posted: | July 17, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The investigators will disseminate findings through publications, national presentations, participation in the CTSA Consortium, the CTSA website and via the existing infrastructure of the Society of Thoracic Surgeons Congenital Heart Surgery Database. Data collection supported by CTSA funds will follow the principles outlined in the Final NIH Statement on Sharing Research Data. Participating institutions will honor the principle that data sharing is critical for expeditious translation of research findings to the improvement of human health. The investigators abide strictly by the provisions of the Health Insurance Portability and Accountability Act (HIPAA). The investigators will continue to use traditional venues for data sharing, such as publications in leading scientific journals and deposit all applicable NIH-funded research results to PubMed Central in compliance with the NIH's Public Access Policy. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Heart Diseases Inflammation Pathologic Processes Cardiovascular Diseases Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Protective Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |