Evaluation of Persistent Organ Dysfunction Plus Death As a Novel Composite Outcome in Cardiac Surgical Patients

详细信息    查看全文

• 作者：Christian Stoppe ; MD^* ; ^&dagger ; ; ^{christian.stoppe@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Bernard McDonald ; MD ; PhD^&Dagger ; ; Carina Benstoem ; MSc^&dagger ; ; Gunnar Elke ; MD^§ ; ; Patrick Meybohm ; MD^‖ ; Richard Whitlock ; MD^¶ ; ; Stephen Fremes ; MD^# ; Robert Fowler ; MD^** ; Yoan Lamarche ; MD^&dagger ; &dagger ; ; Xuran Jiang ; MD^&Dagger ; &Dagger ; ; Andrew G. Day ; MD^&Dagger ; &Dagger ; ; Daren K. Heyland ; MD^&Dagger ; &Dagger ;
• 关键词：cardiac surgery ; organ dysfunctions ; composite outcome measurements
• 刊名：Journal of Cardiothoracic and Vascular Anesthesia
• 出版年：2016
• 出版时间：January 2016
• 年：2016
• 卷：30
• 期：1
• 页码：30-38
• 全文大小：1007 K

文摘

Validated composite outcomes after complicated cardiac surgery are poorly established. Therefore, the authors evaluated a novel composite endpoint, persistent organ dysfunction (POD)+death, which is defined as any need for life-sustaining therapies or death at any time within 28 days from surgery.

Design

Secondary analysis extracted from a large-scale prospective randomized trial of critically ill cardiac surgery patients.

Setting

Multi-institutional, university hospitals.

Participants

Ninety-five cardiac surgery patients with complicated postoperative courses.

Interventions

Cardiac surgery with cardiopulmonary bypass.

Measurements and Main Results

At 28 days following surgery, the prevalence of POD was 15%, and 23% of patients had died (POD+death = 38%). Patients alive with POD at day 28 exhibited a significantly higher extent of organ injury and longer ICU (33 v 7 days; p<0.001) and hospital lengths of stay (49 v 21 days; p<0.001) compared to patients without POD at day 28. At 3 and 6 months, quality-of-life scores (by Short Form 36 questionnaire) showed a significantly reduced rating for most components in patients with POD at day 28 compared to those without POD. The 6-month mortality rate was 21% among patients alive with POD at day 28 compared to 5% among patients alive without POD (p = 0.05). The calculated number of patients needed per arm to detect a 25% relative risk reduction for mortality alone was 762 compared to 386 per arm for POD+ death.

Conclusions

POD+death at day 28 following cardiac surgery may be a valid composite endpoint and offers statistical efficiencies in terms of sample size calculations for cardiac surgical trials.