Ole Hyldegaard, Michael Nekludov, Per Arnell, Torbjørn Nedrebø, Ylva Karlsson, Martin Bruun Madsen, Steinar Skrede, Vitor Martins Dos Santos, Mattias Svensson, Anders Perner, Julie Vinkel, Anders Kjellberg, Anders Rosén, Johan Douglas, Trond Bruun, Christopher Hardt, Anna Norrby-Teglund, Morten Hedetoft
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Most patients with NSTI are severely ill, having sepsis or septic shock, and requiring mechanical ventilation and inotropic support in an intensive care unit (ICU). Although recent data suggest that the beneficial effect of HBO<sub>2</sub> may be largest in the most severely ill, not all patients may receive it due to hemodynamic instability, pressure chamber capabilities, and availability, thereby potentially introducing selection bias.</p><p><strong>Methods: </strong>From January 2013 until June 2017, we conducted a multicenter, prospective, consecutive, observational study (The INFECT study, ClinicalTrials.gov number; NCT01790698) enrolling NSTI patients at five clinical centers delivering HBO<sub>2</sub> to NSTI patients in an ICU setting in Denmark, Norway, and Sweden.</p><p><strong>Results: </strong>A total of 409 consecutive patients with necrotizing soft tissue infections were prospectively enrolled in the study, of whom 402 (98.3%) were admitted to the ICU. A total of 329 NSTI patients received HBO<sub>2</sub>, and 80 patients did not. Median time from arrival at a specialized hospital to first HBO<sub>2</sub> was 4.3 h (IQR 2.5-7.7). Patients receiving HBO<sub>2</sub> had less often chronic liver disease, penetrating trauma within 4 weeks before NSTI, lower extremity NSTI involvement, and acute kidney injury and lower severity scores (Simplified Acute Physiology Score; SAPS-2 and Sequential Organ Failure Assessment score; SOFA score) than patients not treated with HBO<sub>2</sub>. Patients receiving HBO<sub>2</sub> were more frequently on mechanical ventilation. All-cause 30- and 90-day mortality for the HBO<sub>2</sub>-treated patients was 22/325 (7%) and 36/325 (11%) and for non-HBO<sub>2</sub>-treated patients 34/80 (43%) and 37/80 (46%). 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引用次数: 0
摘要
高压氧（HBO2）治疗通常作为坏死性软组织感染（NSTI）患者的辅助治疗。几项观察性研究表明，高压氧（HBO2）治疗与坏死性软组织感染（NSTIs）患者的生存率提高之间存在关联；然而，证据仍然没有定论。大多数NSTI患者病情严重，患有败血症或感染性休克，需要在重症监护病房（ICU）进行机械通气和肌力支持。虽然最近的数据表明，HBO2的有益作用可能在最严重的疾病中最大，但由于血流动力学不稳定，压力室的能力和可用性，并非所有患者都可以接受它，从而可能引入选择偏倚。方法：从2013年1月到2017年6月，我们进行了一项多中心、前瞻性、连续观察性研究(The infection研究，ClinicalTrials.gov编号；NCT01790698)在丹麦、挪威和瑞典的5个临床中心招募NSTI患者，为重症监护病房的NSTI患者提供HBO2。结果：共有409例连续的坏死性软组织感染患者被前瞻性纳入研究，其中402例（98.3%）入住ICU。共有329例NSTI患者接受了HBO2治疗，80例未接受HBO2治疗。从到达专科医院到首次HBO2的中位时间为4.3 h （IQR 2.5-7.7）。接受HBO2治疗的患者较少出现慢性肝病、NSTI前4周内穿透性创伤、下肢NSTI受累、急性肾损伤和较低的严重程度评分(简化急性生理评分；sap -2与序贯器官衰竭评估评分；SOFA评分)高于未接受HBO2治疗的患者。接受HBO2的患者更频繁地使用机械通气。接受hbo2治疗的患者30天和90天全因死亡率分别为22/325（7%）和36/325(11%)，未接受hbo2治疗的患者死亡率分别为34/80（43%）和37/80（46%）。在探索性分析中，HBO2与未调整和性别、乳酸、sap -2和基线去甲肾上腺素输注率调整后的全因30天死亡率降低有关。结论：该队列中接受HBO2治疗的患者比未接受HBO2治疗的患者病情较轻，这可能会影响医生的决定，从而引入选择偏倚。在探索性分析中，使用HBO2与降低30天全因死亡率相关。在NSTI患者中，HBO2治疗的随机试验似乎是有必要的。试验注册：ClinicalTrials.gov号码NCT01790698。
Use of Hyperbaric Oxygen in Patients with Necrotizing Soft Tissue Infections: A Scandinavian Multicenter, Prospective, Observational Cohort.
Introduction: Hyperbaric oxygen (HBO2) treatment is regularly used as adjuvant treatment in patients with necrotizing soft tissue infections (NSTI). Several observational studies have suggested an association between hyperbaric oxygen (HBO2) treatment and improved survival in patients with necrotizing soft tissue infections (NSTIs); however, the evidence remains inconclusive. Most patients with NSTI are severely ill, having sepsis or septic shock, and requiring mechanical ventilation and inotropic support in an intensive care unit (ICU). Although recent data suggest that the beneficial effect of HBO2 may be largest in the most severely ill, not all patients may receive it due to hemodynamic instability, pressure chamber capabilities, and availability, thereby potentially introducing selection bias.
Methods: From January 2013 until June 2017, we conducted a multicenter, prospective, consecutive, observational study (The INFECT study, ClinicalTrials.gov number; NCT01790698) enrolling NSTI patients at five clinical centers delivering HBO2 to NSTI patients in an ICU setting in Denmark, Norway, and Sweden.
Results: A total of 409 consecutive patients with necrotizing soft tissue infections were prospectively enrolled in the study, of whom 402 (98.3%) were admitted to the ICU. A total of 329 NSTI patients received HBO2, and 80 patients did not. Median time from arrival at a specialized hospital to first HBO2 was 4.3 h (IQR 2.5-7.7). Patients receiving HBO2 had less often chronic liver disease, penetrating trauma within 4 weeks before NSTI, lower extremity NSTI involvement, and acute kidney injury and lower severity scores (Simplified Acute Physiology Score; SAPS-2 and Sequential Organ Failure Assessment score; SOFA score) than patients not treated with HBO2. Patients receiving HBO2 were more frequently on mechanical ventilation. All-cause 30- and 90-day mortality for the HBO2-treated patients was 22/325 (7%) and 36/325 (11%) and for non-HBO2-treated patients 34/80 (43%) and 37/80 (46%). In exploratory analyses, HBO2 was associated with lower all-cause 30-day mortality in unadjusted and in that adjusted for sex, lactate, SAPS-2, and baseline norepinephrine infusion rate.
Conclusions: Patients receiving HBO2 in this cohort were less acutely ill than those not receiving HBO2 likely influencing physicians' decisions thereby introducing selection bias. In exploratory analyses, the use of HBO2 was associated with a reduced 30-day all-cause mortality. A randomized trial of HBO2 treatment seems warranted in patients with NSTI.
Trial registration: ClinicalTrials.gov number NCT01790698.
期刊介绍：
Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.
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