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Randomized Controlled Trial
. 2024 Jun 27;19(1):399.
doi: 10.1186/s13019-024-02835-3.

The clinical effectiveness of sivelestat in treating sepsis patients with both acute respiratory distress syndrome and septic cardiomyopathy

Hui Lv #  1 , Langjing Huang #  2 , Xiuhong Yang  1 , Changdong Zhang  3 , Hao Yu  4 , Xiaoke Shang  5
Affiliations
Randomized Controlled Trial

The clinical effectiveness of sivelestat in treating sepsis patients with both acute respiratory distress syndrome and septic cardiomyopathy

Hui Lv et al. J Cardiothorac Surg. .

Abstract

Background: We aimed to assess the efficacy of the neutrophil elastase inhibitor, sivelestat, in the treatment of sepsis-induced acute respiratory distress syndrome (ARDS) and septic cardiomyopathy (SCM).

Methods: Between January 2019 and December 2021, we conducted a randomized trial on patients who had been diagnosed with sepsis-induced acute respiratory distress syndrome (ARDS) and septic cardiomyopathy (SCM) at Wuhan Union Hospital. The patients were divided into two groups by random envelop method, the Sivelestat group and the Control group. We measured the serum concentrations of Interleukin (IL)-6, IL-8, Tumor necrosis factor-α (TNF-α), and High-mobility group box 1 (HMGB1) at five time points, which were the baseline, 12 h, 24 h, 48 h, and 72 h after admission to the ICU. We evaluated the cardiac function by sonography and the heart rate variability (HRV) with 24-hour Holter recording between the time of admission to the intensive care unit (ICU) and 72 h after Sivelestat treatment.

Results: From January 2019 to December 2021, a total of 70 patients were included in this study. The levels of IL-6, IL-8, and TNF-α were significantly lower in the Sivelestat group at different time points (12 h, 24 h, 48 h, and 72 h). HMGB1 levels were significantly lower at 72 h after Sivelestat treatment (19.46 ± 2.63pg/mL vs. 21.20 ± 2.03pg/mL, P = 0.003). The stroke volume (SV), tricuspid annular plane systolic excursion (TAPSE), early to late diastolic transmitral flow velocity (E/A), early (e') and late (a') diastoles were significantly low in the Control group compared with the Sivelestat group. Tei index was high in the Control group compared with the Sivelestat group (0.60 ± 0.08 vs. 0.56 ± 0.07, P = 0.029). The result of HRV showed significant differences in standard deviation of normal-to-normal intervals (SDNN), low frequency (LF), and LF/HF (high frequency) between the two groups.

Conclusions: Sivelestat can significantly reduce the levels of serum inflammatory factors, improve cardiac function, and reduce heart rate variability in patients with Sepsis-induced ARDS and SCM.

Keywords: Acute respiratory distress syndrome; Echocardiography; Electrocardiogram; Septic cardiomyopathy; Sivelestat.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
The enrollment flow chart
Fig. 2
Fig. 2
Changes of IL-6 (A), IL-8 (B), TNF-a (C), and HMGB-1 (D) before and after the treatment of Sivelestat IL-6: Interleukin-6; IL-8: Interleukin-8; TNF-a: Tumor necrosis factor-a; HMGB1: High-mobility group box 1 0 is the time of admission to the ICU (Baseline); 12 h, 24 h, 48 h, and 72 h are respective hours after taking the Sivelestat treatment. Data are presented as Mean ± Standard Deviation
Fig. 3
Fig. 3
Echocardiographic imaging from Parasternal left ventricular short axis view. (A) Echocardiographic imaging at ICU admission. (B) Echocardiographic imaging at 72 h after the Sivelestat treatment
See this image and copyright information in PMC

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