Publications

EffectiveNess of feEding protocol on nutritional thErapy anD clinical outcomes in critically ill patients

Design: a multicenter, cluster-randomized, controlled trial

Status: completed

Keywords: Cluster-randomized trial; Evidence-based guideline;

Intensive care unit; Nutrition therapy

Actively implementing an evidence-based feeding guideline for critically ill patients (NEED): a multicenter, cluster-randomized, controlled trial

Crit Care. 2022 Feb 16. doi: 10.1186/s13054-022-03921-5.

Lu Ke^#^1 2, Jiajia Lin^#¹, Gordon S Doig³, Arthur R H van Zanten⁴, Yang Wang⁵, Juan Xing⁶, Zhongheng Zhang⁷, Tao Chen⁸, Lixin Zhou⁹, Dongpo Jiang¹⁰, Qindong Shi¹¹, Jiandong Lin¹², Jun Liu¹³, Aibin Cheng¹⁴, Yafeng Liang¹⁵, Peiyang Gao¹⁶, Junli Sun¹⁷, Wenming Liu¹⁸, Zhenyu Yang¹⁹, Rumin Zhang²⁰, Wei Xing²¹, An Zhang²², Zhigang Zhou²³, Tingfa Zhou²⁴, Yang Liu²⁵, Fei Tong²⁶, Qiuhui Wang²⁷, Aijun Pan²⁸, Xiaobo Huang²⁹, Chuming Fan³⁰, Weihua Lu³¹, Dongwu Shi³², Lei Wang³³, Wei Li³⁴, Liming Gu³⁵, Yingguang Xie³⁶, Rongqing Sun³⁷, Feng Guo³⁸, Lin Han³⁹, Lihua Zhou⁴⁰, Xiangde Zheng⁴¹, Feng Shan⁴², Jianbo Liu⁴³, Yuhang Ai⁴⁴, Yan Qu⁴⁵, Liandi Li⁴², Hailing Li⁴⁶, Zhiguo Pan⁴⁷, Donglin Xu⁴⁸, Zhiqiang Zou⁴⁹, Yan Gao⁵⁰, Chunli Yang⁵¹, Qiuye Kou⁵², Xijing Zhang⁵³, Jinglan Wu⁵⁴, Chuanyun Qian⁵⁵, Weixing Zhang⁵⁶, Minjie Zhang⁵⁷, Yuan Zong⁵⁸, Bingyu Qin⁵⁹, Fusen Zhang⁶⁰, Zhe Zhai⁶¹, Yun Sun⁶², Ping Chang⁶³, Bo Yu⁶⁴, Min Yu⁶⁵, Shiying Yuan⁶⁶, Yijun Deng⁶⁷, Liyun Zhao⁶⁸, Bin Zang⁶⁹, Yuanfei Li⁷⁰, Fachun Zhou⁷¹, Xiaomei Chen⁷², Min Shao⁷³, Weidong Wu⁷⁴, Ming Wu⁷⁵, Zhaohui Zhang⁷⁶, Yimin Li⁷⁷, Qiang Guo⁷⁸, Zhiyong Wang⁷⁹, Yuanqi Gong⁸⁰, Yunlin Song⁸¹, Kejian Qian⁸², Yongjian Feng⁸³, Baocai Fu⁸⁴, Xueyan Liu⁸⁵, Zhiping Li⁸⁶, Chuanyong Gong⁸⁷, Cheng Sun⁸⁸, Jian Yu⁸⁹, Zhongzhi Tang⁹⁰, Linxi Huang⁹¹, Biao Ma⁹², Zhijie He⁹³, Qingshan Zhou⁹⁴, Rongguo Yu⁹⁵, Zhihui Tong⁹⁶, Weiqin Li^97 98, Chinese Critcal Care Nutrition Trials Group (CCCNTG)

FIGURE 1 Evidence-based feeding guideline.

Figure 2 The flow of clusters (ICUs) and participants (patients) through the trial

TABLE 3 Patient-centered outcomes and adverse events for all enrolled patients

Trajectories of protein intake and 28-day mortality in critically ill patients: A secondary analysis of a cluster-randomized controlled trial

Clin Nutr. 2022 Aug. doi:10.1016/j.clnu.2022.05.017

Jiajia Lin¹, Wensong Chen², Xianghong Ye³, Cheng Lv¹, Yang Liu⁴, Xingwei Jiang⁴, Zhihui Tong¹, Yuxiu Liu⁵, Lu Ke⁶, Weiqin Li⁷, Jieshou Li⁸, Chinese Critical Care Nutrition Trials Group (CCCNTG)

Association between caloric adequacy and short-term clinical outcomes in critically ill patients using a weight-based equation: Secondary analysis of a cluster-randomized controlled trial

Front Nutr. 2022 Sep 2. doi:10.3389/fnut.2022.902986

Cheng Lv¹, Xingwei Jiang², Yi Long³, Zirui Liu¹, Jiajia Lin¹, Cuili Wu⁴, Xianghong Ye⁴, Ruiling Ye³, Yuxiu Liu¹, Man Liu¹, Yang Liu¹, Wensong Chen⁵, Lin Gao¹, Zhihui Tong¹, Lu Ke^1 6, Zhengying Jiang³, Weiqin Li^1 6for the Chinese Critical Care Nutrition Trials Group (CCCNTG)

Intravenous amino acids may mediate the adverse effect of early parenteral nutrition on mortality in critically ill patients requiring mechanical ventilation: A post hoc analysis of the NEED trial

JPEN J Parenter Enteral Nutr. 2022 Oct 9. doi:10.1002/jpen.2455

Therapeutic plasma exchange in patients with sepsis: Secondary analysis of a cluster-randomized controlled trial

J Clin Apher. 2022 Oct 31. doi:10.1002/jca.22027

Xiang Luo¹, Xiaoling Li², Xiaoyan Lai¹, Lu Ke^3 4, Jing Zhou⁵, Man Liu³, Longxiang Cao⁴, Lingyan Fu¹, Chinese Critical Care Nutrition Trials Group (CCCNTG)

Association of energy delivery with short-term survival in mechanically ventilated critically ill adult patients: a secondary analysis of the NEED trial

Eur J Clin Nutr. 2023 Nov 25. doi: 10.1038/s41430-023-01369-6.

Lanting Wang^#¹, Yi Long^#², Zixiong Zhang¹, Jiajia Lin¹, Jing Zhou¹, Gang Li¹, Bo Ye¹, He Zhang¹, Lin Gao¹, Zhihui Tong¹, Weiqin Li^1 3, Lu Ke^4 5, Zhengying Jiang⁶; Chinese Critical Care Nutrition Trials Group (CCCNTG)

Enhanced exclusive enteral nutrition delivery during the first 7 days is associated with decreased 28-day mortality in critically ill patients with normal lactate level: a post hoc analysis of a multicenter randomized trial

Crit Care. 2024 Jan 20;28(1):26. doi: 10.1186/s13054-024-04813-6.

Early protein delivery in critically ill patients with acute kidney injury: post hoc analysis of a multicenter cluster-randomized controlled trial

Burns Trauma. 2024 Jul 24:12:tkae027. doi: 10.1093/burnst/tkae027.

Thymosin Alpha 1 in the pRevention of pAncreatic infeCtion following acute nEcrotizing pancreatitis

Design: a double-blinded multi-centered, randomized control trial

Status: completed

Keywords:Acute pancreatitis; Immunosuppression;Thymosin;

Pancreatic necrosis; Infection

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

Lu Ke^#^1 2, Jing Zhou^#^1 3, Wenjian Mao^#³, Tao Chen⁴, Yin Zhu⁵, Xinting Pan⁶, Hong Mei⁷, Vikesh Singh⁸, James Buxbaum⁹, Gordon Doig¹⁰, Chengjian He¹¹, Weili Gu¹², Weihua Lu¹³, Shumin Tu¹⁴, Haibin Ni¹⁵, Guoxiu Zhang¹⁶, Xiangyang Zhao¹⁷, Junli Sun¹⁸, Weiwei Chen¹⁹, Jingchun Song²⁰, Min Shao²¹, Jianfeng Tu²², Liang Xia⁵, Wenhua He⁵, Qingyun Zhu⁶, Kang Li⁷, Hongyi Yao¹¹, Jingyi Wu¹³, Long Fu¹⁴, Wendi Jiang¹, He Zhang²³, Jiajia Lin¹, Baiqiang Li¹, Zhihui Tong²⁴, John Windsor²⁵, Yuxiu Liu^1 26, Weiqin Li^27 28 29, Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

Table 1 Flowchart

Figure 2 Primary and secondary endpoints

Figure 2 Time- to-infection by day 90

Thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis (TRACE trial): protocol of a multicentre, randomised, double-blind, placebo-controlled, parallel-group trial

BMJ OPEN. 2020 Sep 29. doi: 10.1136/bmjopen-2020-037231. PMID: 32994239

Jing Zhou^#¹, Wenjian Mao^#¹, Lu Ke², Tao Chen³, Wenhua He⁴, Xinting Pan⁵, Miao Chen⁶, Chengjian He⁷, Weili Gu⁸, Jingyi Wu⁹, Jingchun Song¹⁰, Haibin Ni¹¹, Jianfeng Tu¹², Junli Sun¹³, Guoxiu Zhang¹⁴, Weiwei Chen¹⁵, Bing Xue¹⁶, Xiangyang Zhao¹⁷, Min Shao¹⁸, Yuxiu Liu¹⁹, Zhihui Tong¹, Weiqin Li¹, Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

Figure 1 Trial flowchart.

Figure 2 Schedule for participants enrolment, drug administration and data collection.

Prediction of infected pancreatic necrosis in acute necrotizing pancreatitis by the modified pancreatitis activity scoring system

United European Gastroenterol J. 2023 Feb;11(1):69-78. doi: 10.1002/ueg2.12353. PMID:36579414

Wenjian Mao^1 2 3, Kang Li⁴, Jing Zhou^1 2 3, Miao Chen⁴, Bo Ye^1 2 3, Gang Li^1 2 3, Vikesh Singh⁵, James Buxbaum⁶, Xiaoyun Fu⁴, Zhihui Tong^1 2 3, Yuxiu Liu^1 2 7, John Windsor⁸, Weiqin Li^1 2 3, Lu Ke^1 2 3; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

Early mean absolute lymphocyte count in acute necrotizing pancreatitis is associated with infected pancreatic necrosis

Int Immunopharmacol. 2023 Feb 22;117:109883. doi: 10.1016/j.intimp.2023.109883. PMID:36827921

Tianbin Cai¹, Wenjian Mao², Meiqiong Liu¹, Jing Zhou³, Xinyu Wang², Jing Zhou², Yuxiu Liu⁴, Guangyu Lv¹, Lu Ke⁵, Youhua Zhang⁶

Association between pretreatment lymphocyte count and efficacy of immune-enhancing therapy in acute necrotising pancreatitis: a post-hoc analysis of the multicentre, randomised, placebo-controlled TRACE trial

EClinicalMedicine. 2023 Mar 24:58:101915. doi: 10.1016/j.eclinm.2023.101915.

Lu Ke^1 2 3, Wenjian Mao^1 2, Fang Shao⁴, Jing Zhou^1 2, Minyi Xu⁴, Tao Chen⁵, Yuxiu Liu^1 2 3 4, Zhihui Tong^1 2 3, John Windsor⁶, Penglin Ma⁷, Weiqin Li^1 2 3; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

Immune-Enhancing Treatment among Acute Necrotizing Pancreatitis Patients with Metabolic Abnormalities: A Post Hoc Analysis of a Randomized Clinical Trial

Gut Liver. 2024 Feb 15. doi: 10.5009/gnl230326. Online ahead of print.

Early on-demand intervention versus sTandard management among acute necrotIzing pancreatitis patients coMplicated by persIsteNt orGan failure

Design: an open-label multi-center randomized controlled trial

Status: recruiting completed

Keywords: Acute necrotic collection; Acute pancreatitis; Necrosis; Percutaneous drainage; Persistent organ failure

Early on-demand drainage versus standard management among acute necrotizing pancreatitis patients complicated by persistent organ failure: The protocol for an open-label multi-center randomized controlled trial

Pancreatology. 2020 Oct. doi: 10.1016/j.pan.2020.08.012. PMID:32868182

Cheng Qu¹, He Zhang¹, Tao Chen², Yin Zhu³, Quanxing Feng⁴, Feng Guo⁵, Zhiyong Liu⁶, Longxiang Cao¹, Jie Yang¹, Gang Li¹, Bo Ye¹, Jing Zhou¹, Lu Ke⁷, Zhihui Tong⁸, John Windsor⁹, Weiqin Li¹, Chinese Acute Pancreatitis Clinical Trials Group(CAPCTG)

The Diagnosis and Treatment of Local Complications of Acute Necrotizing Pancreatitis in China: A National Survey

Gastroenterol Res Pract. 2021 Jul. doi: 10.1155/2021/6611149. PMID:34335739

Xiaowu Dong^1 2, Wenjian Mao^1 2, Lu Ke², Lin Gao², Jing Zhou², Bo Ye², Gang Li², Anthony Phillips^3 4, Zhihui Tong², John Windsor^3 4 5, Weiqin Li^1 2, Chinese Acute Pancreatitis Clinical Trials Group Capctg⁶

Figure 1 Geographic distribution of the respondents.

Figure 2 Baseline characteristics of respondents.

The clinical outcome from early versus delayed minimally invasive intervention for infected pancreatic necrosis: a systematic review and meta-analysis

Lin Gao¹, He Zhang¹, Gang Li¹, Bo Ye¹, Jing Zhou¹, Zhihui Tong¹, Lu Ke^2 3, John A Windsor⁴, Weiqin Li^5 6, Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

Early on-demand drainage or standard management for acute pancreatitis patients with acute necrotic collections and persistent organ failure: A pilot randomized controlled trial

J Hepatobiliary Pancreat Sci. 2021 Apr. doi: 10.1002/jhbp.915. PMID:33595879

Balanced Crystalloids versus saLine in prEdicted seVERe Acute Pancreatitis patients

Design: a multicenter, stepped-wedge, cluster-randomized, controlled trial

Status: recruiting completed

Keywords: acute kidney injury; acute pancreatitis; crystalloid; intravenous fluid; saline

The Impact of Normal Saline or Balanced Crystalloid on Plasma Chloride Concentration and Acute Kidney Injury in Patients With Predicted Severe Acute Pancreatitis: Protocol of a Phase II, Multicenter, Stepped-Wedge, Cluster-Randomized, Controlled Trial

Front. Med., 04 October 2021. doi.org/10.3389/fmed.2021.731955

Bo Ye¹^†, Mingfeng Huang¹^†, Tao Chen², Gordon Doig³, Bin Wu⁴, Mingzhi Chen⁵, Shumin Tu⁶, Xiaomei Chen⁷, Mei Yang⁸, Guoxiu Zhang⁹, Qiang Li¹⁰, Xinting Pan¹¹, Lijuan Zhao¹², Honghai Xia¹³, Yan Chen¹⁴, Lu Ke^1,14^*, Zhihui Tong¹^*, Rinaldo Bellomo^15,16,17,18, John Windsor¹⁹ and Weiqin Li^1,14 for the Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

Figure 1 Crystalloid assignment during the trial

Figure 2 Schedule of enrollment, interventions, and assessments

Balanced Solution versus Normal Saline in Predicted Severe Acute Pancreatitis: A Stepped Wedge Cluster Randomized Trial

Lu Ke^1 2, Bo Ye¹, Mingfeng Huang¹, Tao Chen³, Gordon Doig⁴, Chao Li⁵, Yingjie Chen⁶, Hongwei Zhang⁷, Lijuan Zhao⁸, Guobing Chen⁸, Shumin Tu⁹, Long Fu⁹, Honghai Xia¹⁰, Dongliang Yang¹⁰, Bin Wu¹¹, Baohua Ye¹¹, Guoxiu Zhang¹², Mei Yang¹³, Qiang Li¹⁴, Xiaomei Chen¹⁵, Xinting Pan¹⁶, Wenjian Mao¹, James Buxbaum¹⁷, Samir Jaber¹⁸, Zhihui Tong¹, Yuxiu Liu^1 19, John Windsor²⁰, Rinaldo Bellomo²¹, Weiqin Li^1 2; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

The effect of early PlasmaphEResis on organ FunctiOn in hypertRiglycerideMia-induced acute pancreatitis

Design: a multi-centered, register-based, observational study

Status: recruiting

Keywords: TG-lowering therapy; acute pancreatitis (AP); cohort study; hypertriglyceridemia (HTG); organ failure free day

The Effect of Plasma Triglyceride-Lowering Therapy on the Evolution of Organ Function in Early Hypertriglyceridemia-Induced Acute Pancreatitis Patients With Worrisome Features (PERFORM Study): Rationale and Design of a Multicenter, Prospective, Observational, Cohort Study

Front Med (Lausanne). 2021 Dec 13. doi: 10.3389/fmed.2021.756337.

Longxiang Cao¹, Jing Zhou^1 2, Mingzhi Chen³, Tao Chen⁴, Man Liu⁵, Wenjian Mao², Jiyan Lin⁶, Donghuang Hong⁷, Weijie Yao⁸, Yi Sun⁹, Kaixiu Qin¹⁰, Feng Guo¹¹, Yun Zhou¹², Qinghai Jiao¹³, Yingjie Chen³, Gang Li¹, Bo Ye¹, Lu Ke^1 5, Zhihui Tong², Yuxiu Liu^1 14, Weiqin Li^1 5, Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

FIGURE 1 Flow chart of participants.

TABLE 1 Schedule of enrollment, assessment and follow up.

Early Plasmapheresis Among Patients With Hypertriglyceridemia-Associated Acute Pancreatitis

JAMA Netw Open. 2023 Jun 1;6(6):e2320802.

Longxiang Cao^1 2, Yingjie Chen^3 4, Siyao Liu⁵, Wei Huang⁶, Dong Wu⁷, Donghuang Hong⁸, Zuozheng Wang⁹, Yi Sun¹⁰, Kaixiu Qin¹¹, Feng Guo¹², Cuizhu Luo¹³, Qinghai Jiao¹⁴, Xiang Luo¹⁵, Jing Zhou¹⁶, Gang Li¹, Bo Ye¹, Tao Chen¹⁷, Man Liu², Wenjian Mao¹⁶, Lanting Wang¹, Shuai Li¹, John A Windsor¹⁸, Yuxiu Liu^1 2 19, Lu Ke^1 2, Zhihui Tong^1 16, Weiqin Li^1 2; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

Recurrence of hypertriglyceridemia-associated acute pancreatitis: A multicenter, prospective cohort study

Eur J Intern Med. 2024 Mar 26:S0953-6205(24)00130-4.

Ling Ding¹, Shuai Li², Longxiang Cao², Lanting Wang², Jing Zhou², Wenjian Mao³, Weiqin Li⁴, Yin Zhu¹, Lu Ke⁵; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

Impact of therapeutic plasmapheresis on the duration of organ failure in patients with hypertriglyceridemia-associated acute pancreatitis

Ann Intensive Care. 2024 Apr 15;14(1):57. doi: 10.1186/s13613-024-01285-3.

Lanting Wang^#^1 2, Jing Zhou^#³, Cheng Lv¹, Donghuang Hong⁴, Zuozheng Wang⁵, Wenjian Mao¹, Yuxiu Liu^1 6 7, Zixiong Zhang¹, Yuanzhen Li¹, Gang Li¹, Bo Ye¹, Baiqiang Li¹, Longxiang Cao^8 9 10, Zhihui Tong^1 2, Weiqin Li^1 2 6, Lu Ke^11 12 13; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

Triglyceride-lowering therapies in hypertriglyceridemia-associated acute pancreatitis in China: a multicentre prospective cohort study

BMC Med. 2024 Nov 15;22(1):535. doi: 10.1186/s12916-024-03755-8.

Jing Zhou^#^1 2 3, Zuozheng Wang^#⁴, Qinghong Liu^#⁵, Longxiang Cao^1 2, Enrique de-Madaria⁶, Gabriele Capurso⁷, Christian Stoppe⁸, Dong Wu⁹, Wei Huang¹⁰, Yingjie Chen^11 12, Siyao Liu¹³, Donghuang Hong¹⁴, Yun Sun¹⁵, Zhenguo Zeng¹⁶, Kaixiu Qin¹⁷, Haibin Ni¹⁸, Yi Sun¹⁹, Yue Long²⁰, Feng Guo²¹, Xiaofeng Liu²², Xisheng Zheng²³, Guoxiu Zhang²⁴, Xiangcheng Zhang²⁵, Kai Zhou²⁶, Yizhe Chen²⁷, Qinghai Jiao²⁸, Xinsen Zou²⁹, Xiang Luo³⁰, Gang Li¹, Bo Ye¹, Chao Li³¹, Lanting Wang¹, Shuai Li¹, John Windsor³², Yuxiu Liu^1 2 33, Zhihui Tong¹, Weiqin Li^34 35 36, Lu Ke^37 38; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

Triglyceride lowering in patients with different severities of hypertriglyceridaemia-associated acute pancreatitis: secondary analysis of a multicentre, prospective cohort study

BMJ Open Gastroenterol. 2025 Jan 22;12(1):e001620. doi: 10.1136/bmjgast-2024-001620.

Xiang Luo¹, Xiaoling Li², Xiaoyan Lai¹, Wenjian Mao³, Lu Ke³, Lingyan Fu¹, Lin Gao⁴, Yaolu Liu⁵

Effect of plasmapheresis versus standard medical treatment in patients with hypertriglyceridemia-associated acute pancreatitis complicated by early organ failure

Design: a multicenter, pragmatic, registry-based randomized controlled trial

Status: recruiting

Keywords: Hypertriglyceridemia; Acute pancreatitis; Plasmapheresis