NCT01595672

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 10, 2012

Status Verified

May 1, 2012

Enrollment Period

10 months

First QC Date

May 4, 2012

Last Update Submit

May 8, 2012

Conditions

Acute Pancreatitis

Keywords

severe acute pancreatitisorgan failuremultiple organ dysfunction syndromesystemic complicationscontinuous veno-venous hemofiltrationblood purificationcontinuous renal replacement therapy

Outcome Measures

Primary Outcomes (1)

  • persistent organ failure or death

    persistent organ failure: organ failure ≥ 48 hours

    1 months

Secondary Outcomes (13)

  • death

    1 months

  • persistent organ failure

    1 months

  • infectious complications

    1 months

  • input fluid volume within first 3 days after admission

    3 days

  • Physiological Parameters 1 day, 2 days, and 3 days after randomization

    3 days

  • +8 more secondary outcomes

Study Arms (2)

EHVCVVH group

ACTIVE COMPARATOR

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

Device: AN69 hemofilter

Control group

ACTIVE COMPARATOR

Patients receive conventional treatments recommended by guidelines only.

Other: conventional treatments

Interventions

AN69 hemofilterDEVICE

An AN69 hemofilter (1.6 m2 surface area, 35-KD limit; Baxter Healthcare Corp. Deerfield, IL, USA) will be used for EHCVVH.

Also known as: high-volume hemofiltration
EHVCVVH group
conventional treatmentsOTHER

Patients receive conventional treatments recommended by guidelines only.

Also known as: standard treatments
Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

PancreatitisMultiple Organ Failure

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhao Qingchuan, PhD & MD

    the First Affiliated Hospital of Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Qingchuan, PhD & MD

CONTACT

86-29-84771503zhaoqc@fmmu.edu.cn

Zhang Xujie, MD

CONTACT

86-13991230324602914766@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 10, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

May 10, 2012

Record last verified: 2012-05

Locations

CN(1)