Evidence map›Paper›PMID 35713670›Full record

Trial reportIntensive care medicine2022

Immune enhancement in patients with predicted severe acute necrotising pancreatitis: a multicentre double-blind randomised controlled trial.

Lu Ke, Jing Zhou, Wenjian Mao, Tao Chen, Yin Zhu, Xinting Pan, Hong Mei, Vikesh Singh, James Buxbaum, Gordon Doig and 28 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Intensive care medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
8.7field-weighted citation impact, top 1% of its field
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

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
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  8. Burns & trauma · 2026
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  17. A novel clinical data management platform for acute pancreatitis.Journal of Zhejiang University. Science. B · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors at 20 institutions in 5 countries.

Lu Ke *Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
Jing Zhou *Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
Wenjian Mao *Department of Critical Care Medicine, Jinling Hospital, Nanjing Medical University, Nanjing, 210010, Jiangsu, China.
Tao ChenDepartment of Public Health, Policy and Systems, Institute of Population Health, Whelan Building, Quadrangle, The University of Liverpool, Liverpool, L69 3GB, UK.
Yin ZhuPancreatic Disease Centre, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.
Xinting PanDepartment of Emergency Intensive Care Unit, The Affiliated Hospital of Qingdao University, Qingdao, 266000, Shandong, China.
Hong MeiDepartment of Critical Care Medicine, The Affiliated Hospital of Zunyi Medical University, Zunyi, 536000, Guizhou, China.
Vikesh SinghPancreatitis Centre, Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
James BuxbaumDivision of Gastroenterology, Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, USA.
Gordon DoigNorthern Clinical School, Royal, North Shore Hospital, University of Sydney, Sydney, Australia.
Chengjian HeDepartment of Critical Care Medicine, the Affiliated Nanhua Hospital, University of South China, Hengyang, 421002, Hunan, China.
Weili GuDepartment of Critical Care Medicine, Affiliated Hospital 2 of Nantong University, Nantong, 226000, Jiangsu, China.
Weihua LuDepartment of Intensive Care Unit, The First Affiliated Hospital of Wannan Medical College, Wuhu, 241001, Anhui, China.
Shumin TuDepartment of Emergency Medicine, Shangqiu First People's Hospital, Shangqiu, 476000, Henan, China.
Haibin NiDepartment of Emergency Medicine, Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine, Nanjing, 210010, Jiangsu, China.
Guoxiu ZhangDepartment of Emergency Medicine, The First Affiliated Hospital and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, 471003, Henan, China.
Xiangyang ZhaoDepartment of Intensive Care Unit, Qilu Hospital of Shandong University, Qingdao, 266000, Shandong, China.
Junli SunDepartment of Intensive Care Unit, Luoyang Central Hospital, Zhengzhou University, Luoyang, 471100, Henan, China.
Weiwei ChenDepartment of Gastroenterology, Clinical Medical College, Yangzhou University, Yangzhou, Jiangsu, China.
Jingchun SongDepartment of Critical Care Medicine, 94Th Hospital of PLA, Nanchang, 330006, Jiangxi, China.
Min ShaoDepartment of Intensive Care Unit, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, Anhui, China.
Jianfeng TuDepartment of Emergency Medicine, Zhejiang Provincial People's Hospital, Hangzhou, 310014, Zhejiang, China.
Liang XiaPancreatic Disease Centre, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.
Wenhua HePancreatic Disease Centre, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.
Qingyun ZhuDepartment of Emergency Intensive Care Unit, The Affiliated Hospital of Qingdao University, Qingdao, 266000, Shandong, China.
Kang LiDepartment of Critical Care Medicine, The Affiliated Hospital of Zunyi Medical University, Zunyi, 536000, Guizhou, China.
Hongyi YaoDepartment of Critical Care Medicine, the Affiliated Nanhua Hospital, University of South China, Hengyang, 421002, Hunan, China.
Jingyi WuDepartment of Intensive Care Unit, The First Affiliated Hospital of Wannan Medical College, Wuhu, 241001, Anhui, China.
Long FuDepartment of Emergency Medicine, Shangqiu First People's Hospital, Shangqiu, 476000, Henan, China.
Wendi JiangDepartment of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
He ZhangDepartment of Critical Care Medicine, Jinling Hospital, Medical School of Southeast University, Nanjing, 210002, Jiangsu, China.
Jiajia LinDepartment of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
Baiqiang LiDepartment of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
Zhihui TongDepartment of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China. njzyantol@aliyun.com.
John WindsorSurgical and Translational Research Centre, Faculty of Medical and Health Sciences, University of Auckland, Auckland, 1142, New Zealand.
Yuxiu LiuDepartment of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
Weiqin LiDepartment of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China. ctgchina@medbit.cn.ORCID http://orcid.org/0000-0002-8807-6784
Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)
Nanjing General Hospital of Nanjing Military Command · CNYangzhou University · CNQilu Hospital of Shandong University · CNNanchang University · CNUniversity of South China · CNFirst Affiliated Hospital of Wannan Medical College · CNQingdao University · CNShangqiu First People's Hospital · CNZunyi Medical University · CN82th Hospital of Pla · CNAnhui Medical University · CNFirst Affiliated Hospital of Henan University of Science and Technology · CNLuoyang Central Hospital Affiliated to Zhengzhou University · CNZhejiang Provincial People's Hospital · CNIntegrated Chinese Medicine (China) · CNNantong University · CNSoutheast University · CNUniversity of Liverpool · GBJohns Hopkins University · USThe University of Sydney · AU

Funding

Science and technology project of Jiangsu Province SBE2016750187
6 · The paper itself

Abstract

purposeInfected pancreatic necrosis (IPN) is a highly morbid complication of acute necrotising pancreatitis (ANP). Since there is evidence of early-onset immunosuppression in acute pancreatitis, immune enhancement may be a therapeutic option. This trial aimed to evaluate whether early immune-enhancing Thymosin alpha 1 (Tα1) treatment reduces the incidence of IPN in patients with predicted severe ANP.

methodsWe conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms. Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline). The primary outcome was the development of IPN during the index admission.

resultsA total of 508 patients were randomised, of whom 254 were assigned to receive Tα1 and 254 placebo. The vast majority of the participants required admission to the intensive care unit (ICU) (479/508, 94.3%). During the index admission, 40/254(15.7%) patients in the Tα1 group developed IPN compared with 46/254 patients (18.1%) in the placebo group (difference -2.4% [95% CI - 7.4 to 5.1%]; p = 0.48). The results were similar across four predefined subgroups. There was no difference in other major complications, including new-onset organ failure (10.6% vs. 15%), bleeding (6.3% vs. 3.5%), and gastrointestinal fistula (2% vs. 2.4%).

conclusionThe immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.

Indexed as

Pancreatitis, Acute NecrotizingAcute DiseaseDouble-Blind MethodHumansTreatment OutcomeAcute pancreatitisImmunosuppressionInfectionPancreatic necrosisThymosin

Identifiers

PMID35713670
PMCPMC9205279
OpenAlexW4283032647

What OpenQuestion holds

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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.