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

Primary Purpose

Acute Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AN69 hemofilter
conventional treatments
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring severe acute pancreatitis, organ failure, multiple organ dysfunction syndrome, systemic complications, continuous veno-venous hemofiltration, blood purification, continuous renal replacement therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing Hospital of Digestive DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EHVCVVH group

Control group

Arm Description

Patients receive conventional treatments recommended by guidelines with adjunctive early high-volume continuous veno-venous hemofiltration (EHVCVVH).

Patients receive conventional treatments recommended by guidelines only.

Outcomes

Primary Outcome Measures

persistent organ failure or death
persistent organ failure: organ failure ≥ 48 hours

Secondary Outcome Measures

death
persistent organ failure
infectious complications
infected necrosis,bacteraemia and pneumonia respectively
input fluid volume within first 3 days after admission
crystalloid fluids and colloid fluids respectively
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
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
total number of surgical interventions
for any purpose
ICU stay
total costs in hospital
output fluid volume in the first, second, third day after admission
output: urine volume,ultrafiltration liquids,gastric drainage and defecation
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
new-onset organ failure
not present at any time in the 24 hours before randomization
new-onset multiple organ dysfunction syndrome

Full Information

First Posted
May 4, 2012
Last Updated
May 8, 2012
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01595672
Brief Title
Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis
Acronym
EHVCVVHSAP
Official Title
Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis: Single-center, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
severe acute pancreatitis, organ failure, multiple organ dysfunction syndrome, systemic complications, continuous veno-venous hemofiltration, blood purification, continuous renal replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EHVCVVH group
Arm Type
Active Comparator
Arm Description
Patients receive conventional treatments recommended by guidelines with adjunctive early high-volume continuous veno-venous hemofiltration (EHVCVVH).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients receive conventional treatments recommended by guidelines only.
Intervention Type
Device
Intervention Name(s)
AN69 hemofilter
Other Intervention Name(s)
high-volume hemofiltration
Intervention Description
An AN69 hemofilter (1.6 m2 surface area, 35-KD limit; Baxter Healthcare Corp. Deerfield, IL, USA) will be used for EHCVVH.
Intervention Type
Other
Intervention Name(s)
conventional treatments
Other Intervention Name(s)
standard treatments
Intervention Description
Patients receive conventional treatments recommended by guidelines only.
Primary Outcome Measure Information:
Title
persistent organ failure or death
Description
persistent organ failure: organ failure ≥ 48 hours
Time Frame
1 months
Secondary Outcome Measure Information:
Title
death
Time Frame
1 months
Title
persistent organ failure
Time Frame
1 months
Title
infectious complications
Description
infected necrosis,bacteraemia and pneumonia respectively
Time Frame
1 months
Title
input fluid volume within first 3 days after admission
Description
crystalloid fluids and colloid fluids respectively
Time Frame
3 days
Title
Physiological Parameters 1 day, 2 days, and 3 days after randomization
Description
Physiological Parameters: APACHE-II score,SOFA score,Body temperature,PaO2/FiO2,BE,PLT,Cr,serum Ca,WBC and Urine volume
Time Frame
3 days
Title
The concentration of inflammatory mediators in serum 0 hour,2 hours,6 hours and 12 hours after early high-volume continuous veno-venous hemofiltration
Description
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
Time Frame
12 hours
Title
total number of surgical interventions
Description
for any purpose
Time Frame
2 months
Title
ICU stay
Time Frame
2 months
Title
total costs in hospital
Time Frame
3 months
Title
output fluid volume in the first, second, third day after admission
Description
output: urine volume,ultrafiltration liquids,gastric drainage and defecation
Time Frame
3 days
Title
persistent multiple organ dysfunction syndrome
Description
multiple organ dysfunction syndrome (two or more organs or occurrence of two or more systemic complications at the same time) ≥ 48 hours
Time Frame
1 months
Title
new-onset organ failure
Description
not present at any time in the 24 hours before randomization
Time Frame
1 months
Title
new-onset multiple organ dysfunction syndrome
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Qingchuan, PhD & MD
Phone
86-29-84771503
Email
zhaoqc@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Xujie, MD
Phone
86-13991230324
Email
602914766@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Qingchuan, PhD & MD
Organizational Affiliation
the First Affiliated Hospital of Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Qingchuan, PhD & MD
Phone
86-29-84771503
Email
zhaoqc@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Zhang Xujie, MD
Phone
86-13991230324
Email
602914766@qq.com
First Name & Middle Initial & Last Name & Degree
Zhao Qingchuan, PhD & MD
First Name & Middle Initial & Last Name & Degree
Zhang Xujie, MD

12. IPD Sharing Statement

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

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