Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis

Not Applicable

• Conditions: Acute Pancreatitis
• Interventions: Device: AN69 hemofilter; Other: conventional treatments

• Registration Number: NCT01595672
• Lead Sponsor: Air Force Military Medical University, China

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.

Study Timeline

• Study Start: 2012-04
• Status Verified: 2012-05
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-08
• Last Update Submitted: 2012-05-08
• Study First Posted: 2012-05-10
• Last Update Posted: 2012-05-10
• Primary Completion: 2013-02
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EHVCVVH group	AN69 hemofilter	Patients receive conventional treatments recommended by guidelines with adjunctive early high-volume continuous veno-venous hemofiltration (EHVCVVH).
Control group	conventional treatments	Patients receive conventional treatments recommended by guidelines only.

Primary Outcome Measures

Name	Time	Method
persistent organ failure or death	1 months	persistent organ failure: organ failure ≥ 48 hours

Secondary Outcome Measures

Name	Time	Method
death	1 months
persistent organ failure	1 months
infectious complications	1 months	infected necrosis,bacteraemia and pneumonia respectively
input fluid volume within first 3 days after admission	3 days	crystalloid fluids and colloid fluids respectively
Physiological Parameters 1 day, 2 days, and 3 days after randomization	3 days	Physiological Parameters: APACHE-II score,SOFA score,Body temperature,PaO2/FiO2,BE,PLT,Cr,serum Ca,WBC and Urine volume
The concentration of inflammatory mediators in serum 0 hour,2 hours,6 hours and 12 hours after early high-volume continuous veno-venous hemofiltration	12 hours	inflammatory mediators: tumor necrosis factor-α, IL-1, IL-2, IL-4, IL-6, and IL-8, IL-10, IL-13, IL-15, Angiopoietin-2, trypsin, resistin and visfatin
total number of surgical interventions	2 months	for any purpose
ICU stay	2 months
total costs in hospital	3 months
output fluid volume in the first, second, third day after admission	3 days	output: urine volume,ultrafiltration liquids,gastric drainage and defecation
persistent multiple organ dysfunction syndrome	1 months	multiple organ dysfunction syndrome (two or more organs or occurrence of two or more systemic complications at the same time) ≥ 48 hours
new-onset organ failure	1 months	not present at any time in the 24 hours before randomization
new-onset multiple organ dysfunction syndrome	1 months

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China