Clinical trial NCT01595672: Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis
Official title: Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis: Single-center, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Keywords: severe acute pancreatitis
organ failure
multiple organ dysfunction syndrome
systemic complications
continuous veno-venous hemofiltration
blood purification
continuous renal replacement therapy
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect and safety of early high-volume continuous veno-venous hemofiltration for patients with severe acute pancreatitis.

Detailed description: The investigators anticipated that early high-volume continuous veno-venous hemofiltration (EHVCVVH) would result in a decrease of the composite of persistent organ failure or death by eliminating inflammatory mediators in blood. This study is designed to evaluate the impact of EHVCVVH on patients with severe acute pancreatitis.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of severe acute pancreatitis
* written informed consent
* Time from onset of abdominal pain to admission ≤ 72 hours
* SIRS score ≥ 2

Exclusion Criteria:

* confirmed infection
* pregnancy
* patients needing emergency operation for abdominal compartment syndrome
* chronic renal diseases needing blood purification
* previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy
* acute flare-up of chronic pancreatitis
* malignancy

Primary outcomes:
measure: persistent organ failure or death
timeFrame: 1 months
Secondary outcomes:
measure: death
timeFrame: 1 months
measure: persistent organ failure
timeFrame: 1 months
measure: infectious complications
timeFrame: 1 months
measure: input fluid volume within first 3 days after admission
timeFrame: 3 days
measure: Physiological Parameters 1 day, 2 days, and 3 days after randomization
timeFrame: 3 days
measure: The concentration of inflammatory mediators in serum 0 hour,2 hours,6 hours and 12 hours after early high-volume continuous veno-venous hemofiltration
timeFrame: 12 hours
measure: total number of surgical interventions
timeFrame: 2 months
measure: ICU stay
timeFrame: 2 months
measure: total costs in hospital
timeFrame: 3 months
measure: output fluid volume in the first, second, third day after admission
timeFrame: 3 days
measure: persistent multiple organ dysfunction syndrome
timeFrame: 1 months
measure: new-onset organ failure
timeFrame: 1 months
measure: new-onset multiple organ dysfunction syndrome
timeFrame: 1 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: the First Affiliated Hospital of Fourth Military Medical University
name: Zhao Qingchuan, PhD & MD
role: PRINCIPAL_INVESTIGATOR
References: