24 Dec The effect of early PlasmaphEResis on organ FunctiOn in hypertRiglycerideMia-induced acute pancreatitis: a multi-centered, register-based, observational study

Posted at 10:06h in Clinical Trials, Ongoing Projects by

 

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) [1]. 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.

 

Hypothesis

The hypothesis is that early plasmapheresis, compared with conservative treatment, could improve organ function in hypertriglyceridemia-induced acute pancreatitis patients.

Primary outcome

The primary outcome is organ failure (OF) free days at day 14.

Population

Inclusion Criteria

  1. Age between 18 to 70 years old;
  2. Within 72 hours from the onset of acute pancreatitis;
  3. 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 [2].
  4. 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:

  1. a) Temperature >38.5°C or <35.0°C
  2. b) Heart rate of >90 beats /min
  3. c) Respiratory rate of >20 breaths/min or PaCO2 of <32 mmHg
  4. 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；

Exclusion Criteria

  1. 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;
  2. Without informed consent, patients refused plasmapheresis and other conditions that may bring about obvious bias;
  3. Pregnant or lactating women; or have a pregnancy plan within 1 month after the test (including male subjects);
  4. Researchers’ family members who are directly involved in the study;
  5. The researchers believe that there is no reason for inclusion, for example, patients are expected to die within 48 hours after enrollment.

References

  1. 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.
  2. 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.