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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Fourth Military Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Qingchuan Zhao, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01595672
First received: May 4, 2012
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Acute Pancreatitis
Device: AN69 hemofilter
Other: conventional treatments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis: Single-center, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • persistent organ failure or death [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    persistent organ failure: organ failure ≥ 48 hours


Secondary Outcome Measures:
  • death [ Time Frame: 1 months ] [ Designated as safety issue: No ]
  • persistent organ failure [ Time Frame: 1 months ] [ Designated as safety issue: No ]
  • infectious complications [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    infected necrosis,bacteraemia and pneumonia respectively

  • input fluid volume within first 3 days after admission [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    crystalloid fluids and colloid fluids respectively

  • Physiological Parameters 1 day, 2 days, and 3 days after randomization [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    for any purpose

  • ICU stay [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • total costs in hospital [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • output fluid volume in the first, second, third day after admission [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    output: urine volume,ultrafiltration liquids,gastric drainage and defecation

  • persistent multiple organ dysfunction syndrome [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    not present at any time in the 24 hours before randomization

  • new-onset multiple organ dysfunction syndrome [ Time Frame: 1 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: April 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: standard 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595672

Contacts
Contact: Zhao Qingchuan, PhD & MD 86-29-84771503 zhaoqc@fmmu.edu.cn
Contact: Zhang Xujie, MD 86-13991230324 602914766@qq.com

Locations
China, Shaanxi
Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Zhao Qingchuan, PhD & MD    86-29-84771503    zhaoqc@fmmu.edu.cn   
Contact: Zhang Xujie, MD    86-13991230324    602914766@qq.com   
Principal Investigator: Zhao Qingchuan, PhD & MD         
Sub-Investigator: Zhang Xujie, MD         
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Zhao Qingchuan, PhD & MD the First Affiliated Hospital of Fourth Military Medical University
  More Information

No publications provided

Responsible Party: Qingchuan Zhao, Clinical Professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01595672     History of Changes
Other Study ID Numbers: SAP-CVVH-XHDD-002, 81170432
Study First Received: May 4, 2012
Last Updated: May 8, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fourth Military Medical University:
severe acute pancreatitis
organ failure
multiple organ dysfunction syndrome
systemic complications
continuous veno-venous hemofiltration
blood purification
continuous renal replacement therapy

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014