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

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

Study Overview

• Status: Unknown
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Other: CVVH 6h; Other: CVVH 10h; Other: CVVHDF 6h

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Department of EICU, Ruijin Hospital,
      • Contact: Enqiang Mao, M.D; Phone Number: 13501747906
      • Sub-Investigator: Jingyi Wu, M.D
      • Principal Investigator: Erzhen Chen, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CVVH 6h; CVVH 6h for first three days	Other: CVVH 6h; CVVH 6h for first three days
Experimental: CVVH 10h; CVVH 10h for first three days	Other: CVVH 10h; CVVH 10h for first three days
Experimental: CVVHDF; CVVHDF 6h for first three days	Other: CVVHDF 6h; CVVHDF 6h for first three days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	Mortality of 28 days	28 days
operation time	operation time of 28 days	28 days
local complication of severe acute pancreatitis	local complication of SAP in 28 days	28 days

Other Outcome Measures

Outcome Measure	Time Frame
ICU and hospital duration	participants will be followed for the duration of hospital stay, an expected average of 8 weeks

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: RenJi Hospital
• Investigators: Study Director: Enqiang Mao, M.D, Department of EICU Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 10, 2013
• First Submitted That Met QC Criteria: November 23, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): November 28, 2013
• Last Update Submitted That Met QC Criteria: November 23, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Systemic Inflammatory Response Syndrome; Continuous Blood Purification
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: SAP BUNDLE-CRRT; 12411950500 (Other Grant/Funding Number: Science and Technology Commission of Shanghai Municipality)