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

NCT ID: NCT01595672

Last Updated: 2012-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EHVCVVH group

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

Group Type ACTIVE_COMPARATOR

AN69 hemofilter

Intervention Type DEVICE

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

Control group

Patients receive conventional treatments recommended by guidelines only.

Group Type ACTIVE_COMPARATOR

conventional treatments

Intervention Type OTHER

Patients receive conventional treatments recommended by guidelines only.

Interventions

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AN69 hemofilter

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

Intervention Type DEVICE

conventional treatments

Patients receive conventional treatments recommended by guidelines only.

Intervention Type OTHER

Other Intervention Names

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high-volume hemofiltration standard treatments

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Qingchuan Zhao

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhao Qingchuan, PhD & MD

Role: PRINCIPAL_INVESTIGATOR

the First Affiliated Hospital of Fourth Military Medical University

Locations

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Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhao Qingchuan, PhD & MD

Role: CONTACT

86-29-84771503

Zhang Xujie, MD

Role: CONTACT

86-13991230324

Facility Contacts

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Zhao Qingchuan, PhD & MD

Role: primary

86-29-84771503

Zhang Xujie, MD

Role: backup

86-13991230324

Other Identifiers

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81170432

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SAP-CVVH-XHDD-002

Identifier Type: -

Identifier Source: org_study_id

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