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

Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis: Single-center, Randomized, Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Device: AN69 hemofilter; Other: conventional treatments

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 Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhao Qingchuan, PhD & MD; Phone Number: 86-29-84771503; Email: zhaoqc@fmmu.edu.cn
• Study Contact Backup: Name: Zhang Xujie, MD; Phone Number: 86-13991230324; Email: 602914766@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital of Digestive Diseases
      • Contact: Zhao Qingchuan, PhD & MD; Phone Number: 86-29-84771503; Email: zhaoqc@fmmu.edu.cn
      • Contact: Zhang Xujie, MD; Phone Number: 86-13991230324; Email: 602914766@qq.com
      • Principal Investigator: Zhao Qingchuan, PhD & MD
      • Sub-Investigator: Zhang Xujie, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EHVCVVH group; Patients receive conventional treatments recommended by guidelines with adjunctive early high-volume continuous veno-venous hemofiltration (EHVCVVH).	Device: AN69 hemofilter; An AN69 hemofilter (1.6 m2 surface area, 35-KD limit; Baxter Healthcare Corp. Deerfield, IL, USA) will be used for EHCVVH.; Other Names: high-volume hemofiltration
Active Comparator: Control group; Patients receive conventional treatments recommended by guidelines only.	Other: conventional treatments; Patients receive conventional treatments recommended by guidelines only.; Other Names: standard treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
persistent organ failure or death	persistent organ failure: organ failure ≥ 48 hours	1 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Zhao Qingchuan, PhD & MD, The First Affiliated Hospital of Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Estimate): May 10, 2012
• Last Update Submitted That Met QC Criteria: May 8, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: continuous renal replacement therapy; severe acute pancreatitis; multiple organ dysfunction syndrome; organ failure; blood purification; systemic complications; continuous veno-venous hemofiltration
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: SAP-CVVH-XHDD-002; 81170432 (Other Grant/Funding Number: the National Natural Science Foundation of China)