Continuous Blood Purification for Regulation of Early Inf... | NCT01998334

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

NCT01998334

Sponsor

Ruijin Hospital

Status

Unknown status

Last Update Posted

Nov 28, 2013Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Acute Pancreatitis

Interventions

CVVH 6h
CVVH 10h
CVVHDF 6h

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
12411950500	Other Grant/Funding Number	Science and Technology Commission of Shanghai Municipality

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Nov 10, 2013

First Submission Date that Met QC Criteria

Nov 23, 2013

First Posted Date

Nov 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2013

Last Update Posted Date

Nov 28, 2013Estimated

Name	Class
RenJi Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CVVH 6h	Experimental	CVVH 6h for first three days	Other: CVVH 6h
CVVH 10h	Experimental	CVVH 10h for first three days	Other: CVVH 10h
CVVHDF	Experimental	CVVHDF 6h for first three days	Other: CVVHDF 6h

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CVVH 6h	Other	CVVH 6h for first three days	CVVH 6h
CVVH 10h

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
mortality	Mortality of 28 days	28 days
operation time	operation time of 28 days	28 days

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of pancreatitis:
- Typical pain
- Increase in serum lipase or amylase
- Onset of abdominal pain within <=72h before admission
The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012
no chronic diseases such as Chronic Obstructive Pulmonary Disease, Diabetes Mellitus and so on
Age from 18 to 65 years old

Besides criteria above, the patient should also satisfied one of these CBP criteria:

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
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
Refractory acid-base and electrocyte balance disorder, metabolic acidosis conservative treatment is not effective.

Exclusion Criteria:

Pregnancy
Chronic pancreatitis
Immunosuppression condition such as HIV, Corticosteroid for 3 weeks in 60 days; White Blood Cell < 0.5*10^9/L for 10 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Enqiang Mao, M.D	Department of EICU Ruijin Hospital	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Department of EICU, Ruijin Hospital,	Recruiting	Shanghai	Shanghai Municipality	200025	China

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis
D018746	Systemic Inflammatory Response Syndrome

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000079664	Continuous Renal Replacement Therapy

Ancestor Terms

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided