NCT01998334

Brief Summary

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

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

3.4 years

First QC Date

November 10, 2013

Last Update Submit

November 23, 2013

Conditions

Acute Pancreatitis

Keywords

Systemic Inflammatory Response SyndromeContinuous Blood Purification

Outcome Measures

Primary Outcomes (1)

  • The Efficiency of CBP with Inflammatory Response

    Efficiency of CBP with inflammatory response was assessed by the following measurements: 1. Inflammatory mediators removal:tumor necrosis factor-α, interleukin(IL-1, IL-2, IL-6, and IL-8, IL-10, sIL-2R)before and after CBP in first three days 2. SIRS parameters variation: (Heart rate, respiratory rate, White Blood Cell, Temperature, C response protein) before and after CBP in first three days

    3 days

Secondary Outcomes (3)

  • mortality

    28 days

  • operation time

    28 days

  • local complication of severe acute pancreatitis

    28 days

Other Outcomes (1)

  • ICU and hospital duration

    participants will be followed for the duration of hospital stay, an expected average of 8 weeks

Study Arms (3)

CVVH 6h

EXPERIMENTAL

CVVH 6h for first three days

Other: CVVH 6h

CVVH 10h

EXPERIMENTAL

CVVH 10h for first three days

Other: CVVH 10h

CVVHDF

EXPERIMENTAL

CVVHDF 6h for first three days

Other: CVVHDF 6h

Interventions

CVVH 6hOTHER

CVVH 6h for first three days

CVVH 6h
CVVH 10hOTHER

CVVH 10h for first three days

CVVH 10h
CVVHDF 6hOTHER

CVVHDF 6h for first three days

CVVHDF

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of pancreatitis:
  • Typical pain
  • Increase in serum lipase or amylase
  • Onset of abdominal pain within \<=72h before admission
  • The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012
  • no chronic diseases such as Chronic Obstructive Pulmonary Disease, Diabetes Mellitus and so on
  • Age from 18 to 65 years old
  • Besides criteria above, the patient should also satisfied one of these CBP criteria:
  • 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
  • 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
  • Refractory acid-base and electrocyte balance disorder, metabolic acidosis conservative treatment is not effective.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of EICU, Ruijin Hospital,

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

PancreatitisSystemic Inflammatory Response Syndrome

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Enqiang Mao, M.D

    Department of EICU Ruijin Hospital

    STUDY DIRECTOR

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
Professor

Study Record Dates

First Submitted

November 10, 2013

First Posted

November 28, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations

CN(1)