PancreatitisNCT01974466
Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis
A study testing Goal A and Goal B in people with Pancreatitis, run by Ruijin Hospital at 1 site in China.
Trial summary
To compare different goals of fluid resuscitation in early stage of acute pancreatitis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Goal A and Goal B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Aug 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase 2. Onset of abdominal pain within <=72h before admission 3. moderate severe or severe acute pancreatitis according to Atlanta criteria revisited in 2012 4. Evidence of >= 1 predictor of fluid resuscitation: Haematocrit >44% (male) or >40% (female), respectively Lactate>4mmol/L; heart rate>120bpm; urine <0.5ml/kg/h for 6 hour; Mean arterial pressure>85 or <60 mmHg
Who cannot join
- 1. Pregnancy 2. New York Heart Association classification >II 3. With pacemaker implantation 4. chronic obstructive pulmonary disease 5. chronic kidney disease 6. Pre-existing disease with life expectancy < 3 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin
Shanghai, Shanghai Municipality, 20000
zhen er chen, PhD, 64370045 ext. 665570, clockming@live.com
Zhen er chen, MD
About this study
To compare different goals of fluid resuscitation in early stage of acute pancreatitis
Read the detailed description
With regard to study of sepsis and several studies of SAP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission（or onset of abdominal pain）, early goal-directed fluid resuscitation has the potential of improving outcome also in SAP. But the goal of fluid resuscitation remained controversial.Several criteria of fluid resuscitation had been described. Ours had been described in previous study, and had shown a ideal result with less incidence of abdominal compartment syndrome and higher survival rate. This study aims to determine a better goal of fluid resuscitation in severe acute pancreatitis.
- Conditions
- Pancreatitis
- Being tested
- Goal A, Goal B
- Keywords
- pancreatitis, resuscitation goal
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal AOther
Also called Ruijin pancreatitis goal
controled fluid therapy：10~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation target： fulfillment of two or more of four criteria:1. HR <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT ≤35%.
Goal BOther
Also called Sepsis goal
controled fluid therapy：10~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation target： fulfillment of all of the following criteria:
1 CVP 8-12 mmHg , 2.MAP 65-85 mm Hg, 3. urine output ≥0.5 ml/kg/h 4. ScvO2 ≤70%
| Study group | Role | What they receive |
|---|---|---|
| Goal A | Active comparator | controled fluid therapy: 5~10ml/kg/hr fulfillment of two or more of four criteria:
1. heart rate <120 beats/min,
2. mean arterial blood pressure 65-85 mm Hg,
3. urine output ≥1 ml/kg /h
4. Hematocrit ≤35%. Receives: Other: Goal A |
| Goal B | Other | controled fluid therapy: 5~10ml/kg/hr fulfillment of all of the following criteria:
1 central venous pressure8-12 mmHg , 2.mean arterial pressure 65-85 mm Hg, 3. urine output ≥0.5 ml/kg/h 4. ScvO2 ≤70% Receives: Other: Goal B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 28day
Secondary outcomes (1)
intra-abdominal Hypertension
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- Qiang En Mao, PhD, Study director, Emergency intensive care unit of Ruijin HospitalMing zhong, MD, Study chair, doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974466
- Sponsor's protocol ID
- RJpancreatitis01
- Other IDs
- RJpancreatitis01
- Status last verified
- Nov 2013
- First submitted
- 26 Oct 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mao EQ, Tang YQ, Fei J, Qin S, Wu J, Li L, Min D, Zhang SD. Fluid therapy for severe acute pancreatitis in acute response stage. Chin Med J (Engl). 2009 Jan 20;122(2):169-73.
PubMed 19187641
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01974466
- Acronym / sponsor ID
- RJpancreatitis01
- Conditions
- Pancreatitis
- Keywords
- pancreatitis, resuscitation goal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- Aug 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 1 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.
To compare different goals of fluid resuscitation in early stage of acute pancreatitis
Detailed description
With regard to study of sepsis and several studies of SAP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission（or onset of abdominal pain）, early goal-directed fluid resuscitation has the potential of improving outcome also in SAP. But the goal of fluid resuscitation remained controversial.Several criteria of fluid resuscitation had been described. Ours had been described in previous study, and had shown a ideal result with less incidence of abdominal compartment syndrome and higher survival rate. This study aims to determine a better goal of fluid resuscitation in severe acute pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal A | Active comparator | Other: Goal Acontroled fluid therapy: 5~10ml/kg/hr fulfillment of two or more of four criteria: 1. heart rate <120 beats/min, 2. mean arterial blood pressure 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. Hematocrit ≤35%. |
| Goal B | Other | Other: Goal Bcontroled fluid therapy: 5~10ml/kg/hr fulfillment of all of the following criteria: 1 central venous pressure8-12 mmHg , 2.mean arterial pressure 65-85 mm Hg, 3. urine output ≥0.5 ml/kg/h 4. ScvO2 ≤70% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase 2. Onset of abdominal pain within <=72h before admission 3. moderate severe or severe acute pancreatitis according to Atlanta criteria revisited in 2012 4. Evidence of >= 1 predictor of fluid resuscitation: Haematocrit >44% (male) or >40% (female), respectively Lactate>4mmol/L; heart rate>120bpm; urine <0.5ml/kg/h for 6 hour; Mean arterial pressure>85 or <60 mmHg
Key exclusion criteria (1 listed)
- 1. Pregnancy 2. New York Heart Association classification >II 3. With pacemaker implantation 4. chronic obstructive pulmonary disease 5. chronic kidney disease 6. Pre-existing disease with life expectancy < 3 months
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 |
|---|---|---|
| Goal AAlso: Ruijin pancreatitis goalcontroled fluid therapy：10~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation target： fulfillment of two or more of four criteria:1. HR <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT ≤35%. | Other | Goal A |
| Goal BAlso: Sepsis goalcontroled fluid therapy：10~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation target： fulfillment of all of the following criteria: 1 CVP 8-12 mmHg , 2.MAP 65-85 mm Hg, 3. urine output ≥0.5 ml/kg/h 4. ScvO2 ≤70% | Other | Goal B |
Primary outcome
Mortality
Time frame: 28day
1 secondary outcome
intra-abdominal Hypertension
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Background: PubMed 19187641Mao EQ, Tang YQ, Fei J, Qin S, Wu J, Li L, Min D, Zhang SD. Fluid therapy for severe acute pancreatitis in acute response stage. Chin Med J (Engl). 2009 Jan 20;122(2):169-73.
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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.
Qiang En Mao, PhD study director
Emergency intensive care unit of Ruijin Hospital
Ming zhong, MD study chair
doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal A and Goal B in people with 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 1 inclusion and 1 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 19 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?
Contact Zhen er Chen, PhD (64370045 ext. 665520, chenerzhen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01974466, which also lists 1 linked publication.
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 19 Nov 2013.