Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis

Acute Pancreatitis Clinical Trial

— EHVCVVHSAP  

Official title:

Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis: Single-center, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01595672
• Other study ID #: SAP-CVVH-XHDD-002
• Secondary ID: 81170432
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2012
• Last updated: May 8, 2012
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2012
• Source: Fourth Military Medical University
• Contact: Zhao Qingchuan, PhD & MD
• Phone: 86-29-84771503
• Email: zhaoqc[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect and safety of early high-volume continuous veno-venous hemofiltration for patients with severe acute pancreatitis.

Description:

The investigators anticipated that early high-volume continuous veno-venous hemofiltration (EHVCVVH) would result in a decrease of the composite of persistent organ failure or death by eliminating inflammatory mediators in blood. This study is designed to evaluate the impact of EHVCVVH on patients with severe acute pancreatitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of severe acute pancreatitis

• written informed consent

• Time from onset of abdominal pain to admission = 72 hours

• SIRS score = 2

Exclusion Criteria:

• confirmed infection

• pregnancy

• patients needing emergency operation for abdominal compartment syndrome

• chronic renal diseases needing blood purification

• previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy

• acute flare-up of chronic pancreatitis

• malignancy

Study Design

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Device:
• AN69 hemofilter
An AN69 hemofilter (1.6 m2 surface area, 35-KD limit; Baxter Healthcare Corp. Deerfield, IL, USA) will be used for EHCVVH.

Other:
• conventional treatments
Patients receive conventional treatments recommended by guidelines only.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	persistent organ failure or death	persistent organ failure: organ failure = 48 hours	1 months	No
Secondary	death		1 months	No
Secondary	persistent organ failure		1 months	No
Secondary	infectious complications	infected necrosis,bacteraemia and pneumonia respectively	1 months	No
Secondary	input fluid volume within first 3 days after admission	crystalloid fluids and colloid fluids respectively	3 days	No
Secondary	Physiological Parameters 1 day, 2 days, and 3 days after randomization	Physiological Parameters: APACHE-II score,SOFA score,Body temperature,PaO2/FiO2,BE,PLT,Cr,serum Ca,WBC and Urine volume	3 days	No
Secondary	The concentration of inflammatory mediators in serum 0 hour,2 hours,6 hours and 12 hours after early high-volume continuous veno-venous hemofiltration	inflammatory mediators: tumor necrosis factor-a, IL-1, IL-2, IL-4, IL-6, and IL-8, IL-10, IL-13, IL-15, Angiopoietin-2, trypsin, resistin and visfatin	12 hours	No
Secondary	total number of surgical interventions	for any purpose	2 months	No
Secondary	ICU stay		2 months	No
Secondary	total costs in hospital		3 months	No
Secondary	output fluid volume in the first, second, third day after admission	output: urine volume,ultrafiltration liquids,gastric drainage and defecation	3 days	No
Secondary	persistent multiple organ dysfunction syndrome	multiple organ dysfunction syndrome (two or more organs or occurrence of two or more systemic complications at the same time) = 48 hours	1 months	No
Secondary	new-onset organ failure	not present at any time in the 24 hours before randomization	1 months	No
Secondary	new-onset multiple organ dysfunction syndrome		1 months	No