24 Dec The effect of early PlasmaphEResis on organ FunctiOn in hypertRiglycerideMia-induced acute pancreatitis: a multi-centered, register-based, observational study
Project abbreviation: PERFORM research
Overall study start date: 12/01/2020
Overall study end date: 11/30/2021
Recruitment start date: 12/01/2021
Background and Objective
The serum level of triglyceride (TG) is correlated with the incidence of hypertriglyceridemia induced acute pancreatitis (HTG-AP). Heparin, insulin, and plasmapheresis have been most commonly used in TG lowering therapy. However, due to the lack of prospective studies related to the effectiveness of therapeutic plasmapheresis on HTG-AP, the effectiveness of plasmapheresis is controversial. According to the American Society for Apheresis (ASFA) guidelines, HTG-AP is a category III, grade 2C indication for therapeutic plasma exchange (TPE) . Therefore, we conduct a multi-centered, register-based, observational study to assess the difference in clinical outcomes between HTG-AP patients who underwent plasmapheresis and those who received only conventional treatment.
The hypothesis is that early plasmapheresis, compared with conservative treatment, could improve organ function in hypertriglyceridemia-induced acute pancreatitis patients.
The primary outcome is organ failure (OF) free days at day 14.
- Age between 18 to 70 years old;
- Within 72 hours from the onset of acute pancreatitis;
- Symptoms and signs of AP based on abdominal pain suggestive of AP, serum amylase at least three times the upper limit of normal, and/or characteristic findings of AP on computed tomography or less commonly magnetic resonance imaging (MRI) or transabdominal ultrasonography according to the Revised Atlanta Criteria .
- When enrolled, TG>1000mg/dL (11.3mmol/L), accompanied by the clinical features of any one or more of the following:
1) Signs of hypocalcemia (calcium levels less than 2 mmol/L)
2) Lactic acidosis (Lactate levels more than 2 mmol/L and PH＜7.35)
3) The systemic inflammatory response syndrome (SIRS) is clinically recognized by the presence of two or more of the following:
- a) Temperature >38.5°C or <35.0°C
- b) Heart rate of >90 beats /min
- c) Respiratory rate of >20 breaths/min or PaCO2 of <32 mmHg
- d) WBC count of >12,000 cells/mL, <4000 cells/mL, or >10 percent immature (band) forms
4) Organ failure defined by the Sequential Organ Failure Assessment score for organ dysfunction respiration, renal and cardiovascular system；
- Contraindications for plasmapheresis: a history of severe allergies to plasma, human albumin, heparin, etc.; mental disorders that do not work well with the treatment; a systemic circulatory failure that is difficult to correct; unsteady heart and cerebral infarction; intracranial hemorrhage or severe cerebral edema with cerebral palsy;
- Without informed consent, patients refused plasmapheresis and other conditions that may bring about obvious bias;
- Pregnant or lactating women; or have a pregnancy plan within 1 month after the test (including male subjects);
- Researchers’ family members who are directly involved in the study;
- The researchers believe that there is no reason for inclusion, for example, patients are expected to die within 48 hours after enrollment.
- Padmanabhan, A., et al., Guidelines on the Use of Therapeutic Apheresis in Clinical Practice – Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Eighth Special Issue. J Clin Apher, 2019. 34(3): p. 171-354.
- Banks, P.A., et al., Classification of acute pancreatitis–2012: revision of the Atlanta classification and definitions by international consensus. Gut, 2013. 62(1): p. 102-11.