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

Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG); Longxiang Cao; Jing Zhou; Mingzhi Chen; Tao Chen; Man Liu; Wenjian Mao; Jiyan Lin; Donghuang Hong; Weijie Yao; Yi Sun; Kaixiu Qin; Feng Guo; Yun Zhou; Qinghai Jiao; Yingjie Chen; Gang Li; Bo Ye; Lu Ke; Zhihui Tong; Yuxiu Liu; Weiqin Li

doi:10.3389/fmed.2021.756337

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

Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)
, Longxiang Cao
, Jing Zhou
, Mingzhi Chen
, Tao Chen
, Man Liu
, Wenjian Mao
, Jiyan Lin
, Donghuang Hong
, Weijie Yao
, Yi Sun
, Kaixiu Qin
, Feng Guo
, Yun Zhou
, Qinghai Jiao
, Yingjie Chen
, Gang Li
, Bo Ye
, Lu Ke
, Zhihui Tong

Yuxiu Liu, Weiqin Li

Nanjing University
Nanjing Medical University
Jinjiang Hospital of Traditional Chinese Medicine
University of Liverpool
First Affiliated Hospital of Xiamen University (Tongan Branch)
Fujian Provincial Hospital
Ningxia Medical University
Suining Central Hospital
The Second Affiliated Hospital of Chongqing Medical University
Sir Run Run Shaw Hospital
Pingxiang People's Hospital
The First Hospital of Handan
Southern Medical University

Research output: Contribution to journal › Article › peer-review

17 Citations (Scopus)

Abstract

Background: Acute pancreatitis (AP) is a potentially life-threatening inflammatory disease with multiple etiologies. The prevalence of hypertriglyceridemia-induced acute pancreatitis (HTG-AP) has been increasing in recent years. It is reported that early triglyceride (TG) levels were associated with the severity of the disease, and TG- lowering therapies, including medical treatment and blood purification, may impact the clinical outcomes. However, there is no consensus regarding the optimal TG-lowering therapy, and clinical practice varies greatly among different centers. Our objective is to evaluate the TG-lowering effects of different therapies and their impact on clinical outcomes in HTG-AP patients with worrisome features.

Methods: This is a multicenter, observational, prospective cohort study. A total of approximately 300 patients with HTG-AP with worrisome features are planned to be enrolled. The primary objective of the study is to evaluate the relationship between TG decline and the evolution of organ failure, and patients will be dichotomized depending on the rate of TG decline. The primary outcome is organ failure (OF) free days to 14 days after enrollment. Secondary outcomes include new-onset organ failure, new-onset multiple-organ failure (MOF), new-onset persistent organ failure (POF), new receipt of organ support, requirement of ICU admission, ICU free days to day 14, hospital free days to day 14, 60-day mortality, AP severity grade (Based on the Revised Atlanta Classification), and incidence of systemic and local complications. Generalized linear model (GLM), Fine and Gray competing risk regression, and propensity score matching will be used for statistical analysis.

Discussion: Results of this study will reveal the current practice of TG-lowering therapy in HTG-AP and provide necessary data for future trials.

Original language	English
Article number	756337
Journal	Frontiers in Medicine
Volume	8
DOIs	https://doi.org/10.3389/fmed.2021.756337
Publication status	Published - 13 Dec 2021
Externally published	Yes

Keywords

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

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Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG), Cao, L., Zhou, J., Chen, M., Chen, T., Liu, M., Mao, W., Lin, J., Hong, D., Yao, W., Sun, Y., Qin, K., Guo, F., Zhou, Y., Jiao, Q., Chen, Y., Li, G., Ye, B., Ke, L., ... Li, W. (2021). 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. Frontiers in Medicine, 8, Article 756337. https://doi.org/10.3389/fmed.2021.756337

Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG) ; Cao, Longxiang ; Zhou, Jing et al. / 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. In: Frontiers in Medicine. 2021 ; Vol. 8.

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title = "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",

abstract = "Background: Acute pancreatitis (AP) is a potentially life-threatening inflammatory disease with multiple etiologies. The prevalence of hypertriglyceridemia-induced acute pancreatitis (HTG-AP) has been increasing in recent years. It is reported that early triglyceride (TG) levels were associated with the severity of the disease, and TG- lowering therapies, including medical treatment and blood purification, may impact the clinical outcomes. However, there is no consensus regarding the optimal TG-lowering therapy, and clinical practice varies greatly among different centers. Our objective is to evaluate the TG-lowering effects of different therapies and their impact on clinical outcomes in HTG-AP patients with worrisome features. Methods: This is a multicenter, observational, prospective cohort study. A total of approximately 300 patients with HTG-AP with worrisome features are planned to be enrolled. The primary objective of the study is to evaluate the relationship between TG decline and the evolution of organ failure, and patients will be dichotomized depending on the rate of TG decline. The primary outcome is organ failure (OF) free days to 14 days after enrollment. Secondary outcomes include new-onset organ failure, new-onset multiple-organ failure (MOF), new-onset persistent organ failure (POF), new receipt of organ support, requirement of ICU admission, ICU free days to day 14, hospital free days to day 14, 60-day mortality, AP severity grade (Based on the Revised Atlanta Classification), and incidence of systemic and local complications. Generalized linear model (GLM), Fine and Gray competing risk regression, and propensity score matching will be used for statistical analysis. Discussion: Results of this study will reveal the current practice of TG-lowering therapy in HTG-AP and provide necessary data for future trials.",

keywords = "acute pancreatitis (AP), cohort study, hypertriglyceridemia (HTG), organ failure free day, TG-lowering therapy",

author = "\{Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)\} and Longxiang Cao and Jing Zhou and Mingzhi Chen and Tao Chen and Man Liu and Wenjian Mao and Jiyan Lin and Donghuang Hong and Weijie Yao and Yi Sun and Kaixiu Qin and Feng Guo and Yun Zhou and Qinghai Jiao and Yingjie Chen and Gang Li and Bo Ye and Lu Ke and Zhihui Tong and Yuxiu Liu and Weiqin Li",

year = "2021",

month = dec,

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doi = "10.3389/fmed.2021.756337",

language = "English",

volume = "8",

journal = "Frontiers in Medicine",

issn = "2296-858X",

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Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG), Cao, L, Zhou, J, Chen, M, Chen, T, Liu, M, Mao, W, Lin, J, Hong, D, Yao, W, Sun, Y, Qin, K, Guo, F, Zhou, Y, Jiao, Q, Chen, Y, Li, G, Ye, B, Ke, L, Tong, Z, Liu, Y & Li, W 2021, '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', Frontiers in Medicine, vol. 8, 756337. https://doi.org/10.3389/fmed.2021.756337

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. / Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG); Cao, Longxiang; Zhou, Jing et al.
In: Frontiers in Medicine, Vol. 8, 756337, 13.12.2021.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG)

AU - Cao, Longxiang

AU - Zhou, Jing

AU - Chen, Mingzhi

AU - Chen, Tao

AU - Liu, Man

AU - Mao, Wenjian

AU - Lin, Jiyan

AU - Hong, Donghuang

AU - Yao, Weijie

AU - Sun, Yi

AU - Qin, Kaixiu

AU - Guo, Feng

AU - Zhou, Yun

AU - Jiao, Qinghai

AU - Chen, Yingjie

AU - Li, Gang

AU - Ye, Bo

AU - Ke, Lu

AU - Tong, Zhihui

AU - Liu, Yuxiu

AU - Li, Weiqin

PY - 2021/12/13

Y1 - 2021/12/13

N2 - Background: Acute pancreatitis (AP) is a potentially life-threatening inflammatory disease with multiple etiologies. The prevalence of hypertriglyceridemia-induced acute pancreatitis (HTG-AP) has been increasing in recent years. It is reported that early triglyceride (TG) levels were associated with the severity of the disease, and TG- lowering therapies, including medical treatment and blood purification, may impact the clinical outcomes. However, there is no consensus regarding the optimal TG-lowering therapy, and clinical practice varies greatly among different centers. Our objective is to evaluate the TG-lowering effects of different therapies and their impact on clinical outcomes in HTG-AP patients with worrisome features. Methods: This is a multicenter, observational, prospective cohort study. A total of approximately 300 patients with HTG-AP with worrisome features are planned to be enrolled. The primary objective of the study is to evaluate the relationship between TG decline and the evolution of organ failure, and patients will be dichotomized depending on the rate of TG decline. The primary outcome is organ failure (OF) free days to 14 days after enrollment. Secondary outcomes include new-onset organ failure, new-onset multiple-organ failure (MOF), new-onset persistent organ failure (POF), new receipt of organ support, requirement of ICU admission, ICU free days to day 14, hospital free days to day 14, 60-day mortality, AP severity grade (Based on the Revised Atlanta Classification), and incidence of systemic and local complications. Generalized linear model (GLM), Fine and Gray competing risk regression, and propensity score matching will be used for statistical analysis. Discussion: Results of this study will reveal the current practice of TG-lowering therapy in HTG-AP and provide necessary data for future trials.

AB - Background: Acute pancreatitis (AP) is a potentially life-threatening inflammatory disease with multiple etiologies. The prevalence of hypertriglyceridemia-induced acute pancreatitis (HTG-AP) has been increasing in recent years. It is reported that early triglyceride (TG) levels were associated with the severity of the disease, and TG- lowering therapies, including medical treatment and blood purification, may impact the clinical outcomes. However, there is no consensus regarding the optimal TG-lowering therapy, and clinical practice varies greatly among different centers. Our objective is to evaluate the TG-lowering effects of different therapies and their impact on clinical outcomes in HTG-AP patients with worrisome features. Methods: This is a multicenter, observational, prospective cohort study. A total of approximately 300 patients with HTG-AP with worrisome features are planned to be enrolled. The primary objective of the study is to evaluate the relationship between TG decline and the evolution of organ failure, and patients will be dichotomized depending on the rate of TG decline. The primary outcome is organ failure (OF) free days to 14 days after enrollment. Secondary outcomes include new-onset organ failure, new-onset multiple-organ failure (MOF), new-onset persistent organ failure (POF), new receipt of organ support, requirement of ICU admission, ICU free days to day 14, hospital free days to day 14, 60-day mortality, AP severity grade (Based on the Revised Atlanta Classification), and incidence of systemic and local complications. Generalized linear model (GLM), Fine and Gray competing risk regression, and propensity score matching will be used for statistical analysis. Discussion: Results of this study will reveal the current practice of TG-lowering therapy in HTG-AP and provide necessary data for future trials.

KW - acute pancreatitis (AP)

KW - cohort study

KW - hypertriglyceridemia (HTG)

KW - organ failure free day

KW - TG-lowering therapy

U2 - 10.3389/fmed.2021.756337

DO - 10.3389/fmed.2021.756337

M3 - Article

AN - SCOPUS:85121921373

SN - 2296-858X

VL - 8

JO - Frontiers in Medicine

JF - Frontiers in Medicine

M1 - 756337

ER -

Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG), Cao L, Zhou J, Chen M, Chen T, Liu M et al. 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. Frontiers in Medicine. 2021 Dec 13;8:756337. doi: 10.3389/fmed.2021.756337