Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Pancreatitis Clinical Trial

Official title:

Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01974466
• Other study ID #: RJpancreatitis01
• Secondary ID: RJpancreatitis01
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2013
• Last updated: November 18, 2013
• Start date: August 2013
• Est. completion date: August 2017

Study information

• Verified date: November 2013
• Source: Ruijin Hospital
• Contact: Zhen er Chen, PhD
• Phone: 64370045
• Email: chenerzhen[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis

Intervention

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%.
• 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%

Locations

Country	Name	City	State
China	Ruijin	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	respiratory failure		14days	Yes
Primary	Mortality		28day	Yes
Secondary	intra-abdominal Hypertension		7 days	Yes