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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01998334
• Other study ID #: SAP BUNDLE-CRRT
• Secondary ID: 12411950500
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2013
• Last updated: November 23, 2013
• Start date: July 2012
• Est. completion date: December 2016

Study information

• Verified date: November 2013
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Other:
• CVVH 6h
CVVH 6h for first three days
• CVVH 10h
CVVH 10h for first three days
• CVVHDF 6h
CVVHDF 6h for first three days

Locations

Country	Name	City	State
China	Department of EICU, Ruijin Hospital,	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU and hospital duration		participants will be followed for the duration of hospital stay, an expected average of 8 weeks	Yes
Primary	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-a, 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	Yes
Secondary	mortality	Mortality of 28 days	28 days	Yes
Secondary	operation time	operation time of 28 days	28 days	Yes
Secondary	local complication of severe acute pancreatitis	local complication of SAP in 28 days	28 days	Yes