Evidence map›Paper›PMID 38937755›Full record

Trial reportJournal of cardiothoracic surgery2024

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

Hui Lv, Langjing Huang, Xiuhong Yang, Changdong Zhang, Hao Yu, Xiaoke Shang

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of cardiothoracic surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Advances in anti-inflammatory treatment of sepsis-associated acute respiratory distress syndrome.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2025
    Review
  9. Article
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Hui Lv *Department of ICU, Wuhan No.1 Hospital, No.215 Zhongshan Avenue, Wuhan, China.
Langjing Huang *Department of Cardiovascular Medicine, Changsha Economic Development Zone Hospital, Changsha, China.
Xiuhong YangDepartment of ICU, Wuhan No.1 Hospital, No.215 Zhongshan Avenue, Wuhan, China.
Changdong ZhangDepartment of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No.1277 Jiefang Avenue, Jianghan District, Wuhan, 430022, Hubei Province, China.
Hao YuDepartment of Cardiology, Wuhan No.1 Hospital, No.215 Zhongshan Avenue, Wuhan, China.
Xiaoke ShangDepartment of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No.1277 Jiefang Avenue, Jianghan District, Wuhan, 430022, Hubei Province, China. sxs_sxk@163.com.

Funding

National Key Research and Development Program of China (No.2016YFA0101100,2016YFA0100900)National Natural Science Foundation of China (81700339)
6 · The paper itself

Abstract

backgroundWe 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).

methodsBetween 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.

resultsFrom 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.

conclusionsSivelestat 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.

Indexed as

CardiomyopathiesGlycineRespiratory Distress SyndromeSepsisSulfonamidesAgedFemaleHumansMaleMiddle AgedSerine Proteinase InhibitorsTreatment OutcomeGlycineSerine Proteinase InhibitorssivelestatSulfonamidesAcute respiratory distress syndromeEchocardiographyElectrocardiogramSeptic cardiomyopathySivelestat

Identifiers

PMID38937755
PMCPMC11210008

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.