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Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis

NCT ID: NCT01998334

Last Updated: 2013-11-28

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-12-31

Brief Summary

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Systemic Inflammatory response syndrome(SIRS) is common in patients with severe acute pancreatitis (SAP) in early stage. Continuous Blood Purification (CBP), especially Continuous Veno-Venous Hemofiltration(CVVH) is proved to have an important role in SAP patients to control SIRS. But the detail treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three kinds of treatment protocols which is CVVH 6h,continuous venovenous hemodiafiltration(CVVHDF) 6h,CVVH 10h for first three days in SAP patients. Compare the vital sign, SIRS parameters, and others between these three groups. This study will try to find a better way for CBP in patients with SAP

Detailed Description

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Condition Severe Acute Pancreatitis

Intervention CVVH 6 hours for first three days CVVH 10 hours for first three days CVVHDF 6 hours for first three days

All therapeutic volume is 45ml/kg.h, Device: Braxter HF 1200

Conditions

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Acute Pancreatitis

Keywords

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Systemic Inflammatory Response Syndrome Continuous Blood Purification

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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CVVH 6h

CVVH 6h for first three days

Group Type EXPERIMENTAL

CVVH 6h

Intervention Type OTHER

CVVH 6h for first three days

CVVH 10h

CVVH 10h for first three days

Group Type EXPERIMENTAL

CVVH 10h

Intervention Type OTHER

CVVH 10h for first three days

CVVHDF

CVVHDF 6h for first three days

Group Type EXPERIMENTAL

CVVHDF 6h

Intervention Type OTHER

CVVHDF 6h for first three days

Interventions

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CVVH 6h

CVVH 6h for first three days

Intervention Type OTHER

CVVH 10h

CVVH 10h for first three days

Intervention Type OTHER

CVVHDF 6h

CVVHDF 6h for first three days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of pancreatitis:

* Typical pain
* Increase in serum lipase or amylase
* Onset of abdominal pain within \<=72h before admission
2. The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012
3. no chronic diseases such as Chronic Obstructive Pulmonary Disease, Diabetes Mellitus and so on
4. Age from 18 to 65 years old

Besides criteria above, the patient should also satisfied one of these CBP criteria:

1. Have Acute Kidney Injury satisfied RIFLE classification (risk above): increased Serum Creatinine \> 1.5 times baseline，26.5umol/L increase, or urine output \< 0.5ml/kg.h for 6 hours
2. Systemic Inflammatory Response Syndrome: temperature \>38℃ or\<36℃；heart rate respiratory rate White blood cell count \>12\*10\^9/L，or\< 4\*10\^9/L
3. Refractory acid-base and electrocyte balance disorder, metabolic acidosis conservative treatment is not effective.

Exclusion Criteria

1. Pregnancy
2. Chronic pancreatitis
3. Immunosuppression condition such as HIV, Corticosteroid for 3 weeks in 60 days; White Blood Cell \< 0.5\*10\^9/L for 10 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erzhen Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enqiang Mao, M.D

Role: STUDY_DIRECTOR

Department of EICU Ruijin Hospital

Locations

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Department of EICU, Ruijin Hospital,

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Erzhen Chen, M.D

Role: primary

Enqiang Mao, M.D

Role: backup

Other Identifiers

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12411950500

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SAP BUNDLE-CRRT

Identifier Type: -

Identifier Source: org_study_id