Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Overview

To compare different goals of fluid resuscitation in early stage of acute pancreatitis

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 2016

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.

Interventions

  • Other: Goal A
    • 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%.
  • Other: Goal B
    • 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%

Arms, Groups and Cohorts

  • Active Comparator: Goal A
    • 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 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%

Clinical Trial Outcome Measures

Primary Measures

  • Mortality
    • Time Frame: 28day

Secondary Measures

  • intra-abdominal Hypertension
    • Time Frame: 7 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ruijin Hospital
  • Collaborator
    • RenJi Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Erzhen Chen, Professor – Ruijin Hospital
  • Overall Official(s)
    • Qiang En Mao, PhD, Study Director, Emergency intensive care unit of Ruijin Hospital
    • Ming zhong, MD, Study Chair, doctor
  • Overall Contact(s)
    • Zhen er Chen, PhD, 64370045, chenerzhen@hotmail.com

References

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.

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