Back to resultsContinuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis
Primary Purpose
Acute Pancreatitis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CVVH 6h
CVVH 10h
CVVHDF 6h
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pancreatitis focused on measuring Systemic Inflammatory Response Syndrome, Continuous Blood Purification
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Sites / Locations
- Department of EICU, Ruijin Hospital,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
CVVH 6h
CVVH 10h
CVVHDF
Arm Description
CVVH 6h for first three days
CVVH 10h for first three days
CVVHDF 6h for first three days
Outcomes
Primary Outcome Measures
The Efficiency of CBP with Inflammatory Response
Efficiency of CBP with inflammatory response was assessed by the following measurements:
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
SIRS parameters variation: (Heart rate, respiratory rate, White Blood Cell, Temperature, C response protein) before and after CBP in first three days
Secondary Outcome Measures
mortality
Mortality of 28 days
operation time
operation time of 28 days
local complication of severe acute pancreatitis
local complication of SAP in 28 days
Full Information
NCT ID
NCT01998334
First Posted
November 10, 2013
Last Updated
November 23, 2013
Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01998334
Brief Title
Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis
Official Title
Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
Systemic Inflammatory Response Syndrome, Continuous Blood Purification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CVVH 6h
Arm Type
Experimental
Arm Description
CVVH 6h for first three days
Arm Title
CVVH 10h
Arm Type
Experimental
Arm Description
CVVH 10h for first three days
Arm Title
CVVHDF
Arm Type
Experimental
Arm Description
CVVHDF 6h for first three days
Intervention Type
Other
Intervention Name(s)
CVVH 6h
Intervention Description
CVVH 6h for first three days
Intervention Type
Other
Intervention Name(s)
CVVH 10h
Intervention Description
CVVH 10h for first three days
Intervention Type
Other
Intervention Name(s)
CVVHDF 6h
Intervention Description
CVVHDF 6h for first three days
Primary Outcome Measure Information:
Title
The Efficiency of CBP with Inflammatory Response
Description
Efficiency of CBP with inflammatory response was assessed by the following measurements:
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
SIRS parameters variation: (Heart rate, respiratory rate, White Blood Cell, Temperature, C response protein) before and after CBP in first three days
Time Frame
3 days
Secondary Outcome Measure Information:
Title
mortality
Description
Mortality of 28 days
Time Frame
28 days
Title
operation time
Description
operation time of 28 days
Time Frame
28 days
Title
local complication of severe acute pancreatitis
Description
local complication of SAP in 28 days
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
ICU and hospital duration
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 8 weeks
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:
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enqiang Mao, M.D
Organizational Affiliation
Department of EICU Ruijin Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of EICU, Ruijin Hospital,
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erzhen Chen, M.D
Phone
86-13901753478
First Name & Middle Initial & Last Name & Degree
Enqiang Mao, M.D
Phone
13501747906
First Name & Middle Initial & Last Name & Degree
Jingyi Wu, M.D
First Name & Middle Initial & Last Name & Degree
Erzhen Chen, M.D
12. IPD Sharing Statement
Learn more about this trial
Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis
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