Clinical trial NCT01998334: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Keywords: Systemic Inflammatory Response Syndrome
Continuous Blood Purification
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
First posted: 2013-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: The Efficiency of CBP with Inflammatory Response
timeFrame: 3 days
Secondary outcomes:
measure: mortality
timeFrame: 28 days
measure: operation time
timeFrame: 28 days
measure: local complication of severe acute pancreatitis
timeFrame: 28 days
Other outcomes:
measure: ICU and hospital duration
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Locations:
city: Shanghai
country: China
facility: Department of EICU, Ruijin Hospital,
state: Shanghai
Study officials:
affiliation: Department of EICU Ruijin Hospital
name: Enqiang Mao, M.D
role: STUDY_DIRECTOR
References: