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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01998334
Enrollment
30
Registered
2013-11-28
Start date
2012-07-31
Completion date
2016-12-31
Last updated
2013-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

Keywords

Systemic Inflammatory Response Syndrome, Continuous Blood Purification

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

Interventions

OTHERCVVH 6h

CVVH 6h for first three days

OTHERCVVH 10h

CVVH 10h for first three days

OTHERCVVHDF 6h

CVVHDF 6h for first three days

Sponsors

RenJi Hospital
CollaboratorOTHER
Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Efficiency of CBP with Inflammatory Response3 daysEfficiency 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

MeasureTime frameDescription
mortality28 daysMortality of 28 days
operation time28 daysoperation time of 28 days
local complication of severe acute pancreatitis28 dayslocal complication of SAP in 28 days

Other

MeasureTime frame
ICU and hospital durationparticipants will be followed for the duration of hospital stay, an expected average of 8 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026