Acute PancreatitisEHVCVVHSAPNCT01595672
Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis
A study testing AN69 hemofilter and conventional treatments in people with Acute Pancreatitis, run by Air Force Military Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- AN69 hemofilter and conventional treatments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of severe acute pancreatitis
- written informed consent
- Time from onset of abdominal pain to admission ≤ 72 hours
- SIRS score ≥ 2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Zhao Qingchuan, PhD & MD, 86-29-84771503, zhaoqc@fmmu.edu.cn
Zhang Xujie, MD, 86-13991230324, 602914766@qq.com
About this study
Official title: Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis: Single-center, Randomized, Controlled Trial
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.
Read the detailed 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.
- Conditions
- Acute Pancreatitis
- Being tested
- AN69 hemofilter, conventional treatments
- Keywords
- severe acute pancreatitis, organ failure, multiple organ dysfunction syndrome, systemic complications, continuous veno-venous hemofiltration, blood purification, continuous renal replacement therapy
- Medical subject headings
- Pancreatitis, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN69 hemofilterDevice
Also called high-volume hemofiltration
An AN69 hemofilter (1.6 m2 surface area, 35-KD limit; Baxter Healthcare Corp. Deerfield, IL, USA) will be used for EHCVVH.
conventional treatmentsOther
Also called standard treatments
Patients receive conventional treatments recommended by guidelines only.
| Study group | Role | What they receive |
|---|---|---|
| EHVCVVH group | Active comparator | Patients receive conventional treatments recommended by guidelines with adjunctive early high-volume continuous veno-venous hemofiltration (EHVCVVH). Receives: Device: AN69 hemofilter |
| Control group | Active comparator | Patients receive conventional treatments recommended by guidelines only. Receives: Other: conventional treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
persistent organ failure or death
persistent organ failure: organ failure ≥ 48 hours
Measured: 1 months
Secondary outcomes (13)
death
Measured: 1 months
persistent organ failure
Measured: 1 months
infectious complications
infected necrosis,bacteraemia and pneumonia respectively
Measured: 1 months
input fluid volume within first 3 days after admission
crystalloid fluids and colloid fluids respectively
Measured: 3 days
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
Measured: 3 days
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-α, IL-1, IL-2, IL-4, IL-6, and IL-8, IL-10, IL-13, IL-15, Angiopoietin-2, trypsin, resistin and visfatin
Measured: 12 hours
total number of surgical interventions
for any purpose
Measured: 2 months
ICU stay
Measured: 2 months
total costs in hospital
Measured: 3 months
output fluid volume in the first, second, third day after admission
output: urine volume,ultrafiltration liquids,gastric drainage and defecation
Measured: 3 days
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
Measured: 1 months
new-onset organ failure
not present at any time in the 24 hours before randomization
Measured: 1 months
new-onset multiple organ dysfunction syndrome
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingchuan Zhao, Air Force Military Medical University, China
- Investigators
- Zhao Qingchuan, PhD & MD, Principal investigator, the First Affiliated Hospital of Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595672
- Sponsor's protocol ID
- SAP-CVVH-XHDD-002
- Other IDs
- 81170432
- Acronym
- EHVCVVHSAP
- Status last verified
- May 2012
- First submitted
- 4 May 2012
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis: Single-center, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01595672
- Acronym / sponsor ID
- EHVCVVHSAP / SAP-CVVH-XHDD-002
- Conditions
- Acute Pancreatitis
- Keywords
- severe acute pancreatitis, organ failure, multiple organ dysfunction syndrome, systemic complications, continuous veno-venous hemofiltration, blood purification, continuous renal replacement therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EHVCVVH group | Active comparator | Device: AN69 hemofilterPatients receive conventional treatments recommended by guidelines with adjunctive early high-volume continuous veno-venous hemofiltration (EHVCVVH). |
| Control group | Active comparator | Other: conventional treatmentsPatients receive conventional treatments recommended by guidelines only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of severe acute pancreatitis
- written informed consent
- Time from onset of abdominal pain to admission ≤ 72 hours
- SIRS score ≥ 2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AN69 hemofilterAlso: high-volume hemofiltrationAn AN69 hemofilter (1.6 m2 surface area, 35-KD limit; Baxter Healthcare Corp. Deerfield, IL, USA) will be used for EHCVVH. | Device | EHVCVVH group |
| conventional treatmentsAlso: standard treatmentsPatients receive conventional treatments recommended by guidelines only. | Other | Control group |
Primary outcome
persistent organ failure or death
Time frame: 1 months
persistent organ failure: organ failure ≥ 48 hours
13 secondary outcomes
death
Time frame: 1 months
persistent organ failure
Time frame: 1 months
infectious complications
Time frame: 1 months
input fluid volume within first 3 days after admission
Time frame: 3 days
Physiological Parameters 1 day, 2 days, and 3 days after randomization
Time frame: 3 days
The concentration of inflammatory mediators in serum 0 hour,2 hours,6 hours and 12 hours after early high-volume continuous veno-venous hemofiltration
Time frame: 12 hours
total number of surgical interventions
Time frame: 2 months
ICU stay
Time frame: 2 months
total costs in hospital
Time frame: 3 months
output fluid volume in the first, second, third day after admission
Time frame: 3 days
persistent multiple organ dysfunction syndrome
Time frame: 1 months
new-onset organ failure
Time frame: 1 months
new-onset multiple organ dysfunction syndrome
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao Qingchuan, PhD & MD principal investigator
the First Affiliated Hospital of Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AN69 hemofilter and conventional treatments in people with Acute Pancreatitis, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Qingchuan, PhD & MD (86-29-84771503, zhaoqc@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
persistent organ failure or death (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.