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

Not Applicable

• Conditions: Acute Pancreatitis
• Interventions: Other: CVVH 10h; Other: CVVH 6h; Other: CVVHDF 6h

• Registration Number: NCT01998334
• Lead Sponsor: Ruijin Hospital

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

Study Timeline

• Study Start: 2012-07
• Status Verified: 2013-11
• Study First Submitted: 2013-11-10
• Study First Submitted QC: 2013-11-23
• Last Update Submitted: 2013-11-23
• Study First Posted: 2013-11-28
• Last Update Posted: 2013-11-28
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVVH 10h	CVVH 10h	CVVH 10h for first three days
CVVH 6h	CVVH 6h	CVVH 6h for first three days
CVVHDF	CVVHDF 6h	CVVHDF 6h for first three days

Primary Outcome Measures

Name	Time	Method
The Efficiency of CBP with Inflammatory Response	3 days	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

Secondary Outcome Measures

Name	Time	Method
operation time	28 days	operation time of 28 days
mortality	28 days	Mortality of 28 days
local complication of severe acute pancreatitis	28 days	local complication of SAP in 28 days

Trial Locations

Locations (1)

Department of EICU, Ruijin Hospital,; 🇨🇳 Shanghai, Shanghai, China