Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

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

Study Overview

• Status: Unknown
• Conditions: Pancreatitis
• Intervention / Treatment: Other: Goal A; Other: Goal B

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20000
      • Recruiting
      • Ruijin
      • Contact: zhen er chen, PhD; Phone Number: 665570 64370045; Email: clockming@live.com
      • Principal Investigator: Zhen er chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 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 Names: Ruijin pancreatitis goal
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%	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%; Other Names: Sepsis goal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	28day

Secondary Outcome Measures

Outcome Measure	Time Frame
intra-abdominal Hypertension	7 days

Other Outcome Measures

Outcome Measure	Time Frame
respiratory failure	14days

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: RenJi Hospital
• Investigators: Study Director: Qiang en Mao, phd, Emergency intensive care unit of Ruijin Hospital; Study Chair: Ming zhong, MD, doctor

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: October 26, 2013
• First Submitted That Met QC Criteria: October 26, 2013
• First Posted (Estimate): November 1, 2013

Study Record Updates

• Last Update Posted (Estimate): November 19, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: pancreatitis; resuscitation goal
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: RJpancreatitis01 (Registry Identifier: RuijinH)