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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Acute Pancreatitis

Treatments: Other: CVVH 10h; Other: CVVH 6h; Other: CVVHDF 6h

Study type: Interventional

Funder types: Other

Identifiers

NCT01998334

12411950500 (Other Grant/Funding Number)

SAP BUNDLE-CRRT

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

CVVH 6h

Experimental group

Description:

CVVH 6h for first three days

Treatment:

Other: CVVH 6h

CVVH 10h

Experimental group

Description:

CVVH 10h for first three days

Treatment:

Other: CVVH 10h

CVVHDF

Experimental group

Description:

CVVHDF 6h for first three days

Treatment:

Other: CVVHDF 6h