A composite outcome for neonatal cardiac surgery research

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• 作者：Ryan J. Butts ; Mark A. Scheurer ; Sinai C. Zyblewski ; Amy E. Wahlquist ; Paul J. Nietert ; Scott M. Bradley ; Andrew M. Atz ; Eric M. Graham
• 关键词：20 ; 21
• 刊名：The Journal of Thoracic and Cardiovascular Surgery
• 出版年：January, 2014
• 年：2014
• 卷：147
• 期：1
• 页码：428-433
• 全文大小：178 K

文摘

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Objective

The objective of this study was to determine whether a composite outcome, derived of objective signs of inadequate cardiac output, would be associated with other important measures of outcomes and therefore be an appropriate end point for clinical trials in neonatal cardiac surgery.

Methods

Neonates (n聽=聽76) undergoing cardiac operations requiring cardiopulmonary bypass were prospectively enrolled. Patients were defined to have met the composite outcome if they had any of the following events before hospital discharge: death, the use of mechanical circulatory support, cardiac arrest requiring chest compressions, hepatic injury (2 times the upper limit of normal for aspartate aminotransferase or alanine aminotransferase), renal injury (creatinine >1.5聽mg/dL), or lactic acidosis (an increasing lactate >5聽mmol/L in the postoperative period). Associations between the composite outcome and the duration of mechanical ventilation, intensive care unit stay, hospital stay, and total hospital charges were determined.

Results

The median age at the time of surgery was 7聽days, and the median weight was 3.2聽kg. The composite outcome was met in 39% of patients (30/76). Patients who met the composite outcome compared with those who did not had a longer duration of mechanical ventilation (4.9 vs 2.9聽days, P聽<聽.01), intensive care unit stay (8.8 vs 5.7聽days, P聽<聽.01), hospital stay (23 vs 12聽days, P聽<聽.01), and increased hospital charges ($258,000 vs $170,000, P聽<聽.01). In linear regression analysis, controlling for surgical complexity, these differences remained significant (R²聽=聽0.29-0.42, P聽<聽.01).

Conclusions

The composite outcome is highly associated with important early operative outcomes and may serve as a useful end point for future clinical research in neonates undergoing cardiac operations.