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Perioperative administration of steroids has been demonstrated to reduce systemic inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass. However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis of the present study: intraoperative administration of dexamethasone reduces complication rates and improves clinical outcomes in infants undergoing repair of congenital heart defects under cardiopulmonary bypass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Dexamethasone 1 mg per 1 kg of body weight intravenously immediately after induction of anesthesia |
|
| Control | Placebo Comparator | 0.9% Sodium Chloride 0.25 ml per 1 kg of body weight intravenously immediately after induction of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Major complications | Composite of all-cause death, myocardial infarction, need for extracorporeal membrane oxygenation implantation, cardiac arrest, acute renal failure (stage "injury" or higher according to pRIFLE scale), prolonged mechanical ventilation (> 24 hours), stroke, seizure, coma. | 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Lomivorotov, PhD | Novosibirsk Research Institute of Circulation Pathology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dante Pazzanese Cardiology Institute | São Paulo | Brazil | ||||
| Shanghai Childrens Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33045104 | Derived | 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. | |
| 32573670 |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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0.9% Sodium Chloride |
|
| Shanghai |
| China |
| Novosibirsk Research Institute of Circulation Pathology | Novosibirsk | 630055 | Russia |
| Federal Center of Cardiovascular Surgery, Penza city | Penza | Russia |
| Lomivorotov V, Kornilov I, Boboshko V, Shmyrev V, Bondarenko I, Soynov I, Voytov A, Polyanskih S, Strunin O, Bogachev-Prokophiev A, Landoni G, Nigro Neto C, Oliveira Nicolau G, Saurith Izquierdo L, Nogueira Nascimento V, Wen Z, Renjie H, Haibo Z, Bazylev V, Evdokimov M, Sulejmanov S, Chernogrivov A, Ponomarev D. Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial. JAMA. 2020 Jun 23;323(24):2485-2492. doi: 10.1001/jama.2020.8133. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |