Acute PancreatitisNCT01998334
Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis
A study testing CVVH 6h, CVVH 10h and CVVHDF 6h in people with Acute Pancreatitis, run by Ruijin Hospital at 1 site in China.
Trial 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. 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?
- CVVH 6h, CVVH 10h and CVVHDF 6h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Dec 2016
- 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
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of EICU, Ruijin Hospital,
Shanghai, Shanghai Municipality, 200025
Erzhen Chen, M.D, 86-13901753478
Enqiang Mao, M.D, 13501747906
About this study
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
Read the 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
- Conditions
- Acute Pancreatitis
- Being tested
- CVVH 6h, CVVH 10h, CVVHDF 6h
- Keywords
- Systemic Inflammatory Response Syndrome, Continuous Blood Purification
- Medical subject headings
- Pancreatitis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVVH 6hOther
CVVH 6h for first three days
CVVH 10hOther
CVVH 10h for first three days
CVVHDF 6hOther
CVVHDF 6h for first three days
| Study group | Role | What they receive |
|---|---|---|
| CVVH 6h | Experimental | CVVH 6h for first three days Receives: Other: CVVH 6h |
| CVVH 10h | Experimental | CVVH 10h for first three days Receives: Other: CVVH 10h |
| CVVHDF | Experimental | CVVHDF 6h for first three days Receives: Other: CVVHDF 6h |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (3)
mortality
Mortality of 28 days
Measured: 28 days
operation time
operation time of 28 days
Measured: 28 days
local complication of severe acute pancreatitis
local complication of SAP in 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (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.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Principal investigator, Erzhen Chen, Ruijin Hospital
- Investigators
- Enqiang Mao, M.D, Study director, Department of EICU Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998334
- Sponsor's protocol ID
- SAP BUNDLE-CRRT
- Other IDs
- 12411950500
- Status last verified
- Nov 2013
- First submitted
- 10 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01998334
- Acronym / sponsor ID
- SAP BUNDLE-CRRT
- Conditions
- Acute Pancreatitis
- Keywords
- Systemic Inflammatory Response Syndrome, Continuous Blood Purification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Nov 2013 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CVVH 6h | Experimental | Other: CVVH 6hCVVH 6h for first three days |
| CVVH 10h | Experimental | Other: CVVH 10hCVVH 10h for first three days |
| CVVHDF | Experimental | Other: CVVHDF 6hCVVHDF 6h for first three days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of pancreatitis:
- 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
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| CVVH 6hCVVH 6h for first three days | Other | CVVH 6h |
| CVVH 10hCVVH 10h for first three days | Other | CVVH 10h |
| CVVHDF 6hCVVHDF 6h for first three days | Other | CVVHDF |
Primary outcome
The Efficiency of CBP with Inflammatory Response
Time frame: 3 days
Efficiency 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
3 secondary outcomes
mortality
Time frame: 28 days
operation time
Time frame: 28 days
local complication of severe acute pancreatitis
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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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.
Enqiang Mao, M.D study director
Department of EICU Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVVH 6h, CVVH 10h and CVVHDF 6h in people with Acute Pancreatitis, run by Ruijin Hospital 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 11 inclusion and 3 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 28 Nov 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Efficiency of CBP with Inflammatory Response (time frame: 3 days). 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 28 Nov 2013.