Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Study Overview
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Brief Summary
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To compare different goals of fluid resuscitation in early stage of acute pancreatitis

Detailed Description
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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.

Official Title
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Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Conditions
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Pancreatitis

Intervention / Treatment
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* Other: Goal A
* Other: Goal B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Goal A<br>controled fluid therapy: 5 10ml/kg/hr fulfillment of two or more of four criteria: heart rate <120 beats/min, mean arterial blood pressure 65-85 mm Hg, urine output ≥1 ml/kg /h Hematocrit ≤35%. | Other: Goal A<br>* 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%.<br>* Other names: Ruijin pancreatitis goal;|
| Other: Goal B<br>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% | Other: Goal B<br>* 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%<br>* Other names: Sepsis goal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 28day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-abdominal Hypertension |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatitis, resuscitation goal