Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Not Applicable

• Conditions: Pancreatitis
• Interventions: Other: Goal A; Other: Goal B

• Registration Number: NCT01974466
• Lead Sponsor: Ruijin Hospital

Brief Summary

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-10-26
• Status Verified: 2013-11
• Study First Posted: 2013-11-01
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19
• Primary Completion: 2016-09
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Goal A	Goal A	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%.
Goal B	Goal B	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%

Primary Outcome Measures

Name	Time	Method
Mortality	28day

Secondary Outcome Measures

Name	Time	Method
intra-abdominal Hypertension	7 days

Trial Locations

Locations (1)

Ruijin; 🇨🇳 Shanghai, Shanghai, China