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Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ruijin Hospital
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
Erzhen Chen, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01974466
First received: October 26, 2013
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Pancreatitis
Other: Goal A
Other: Goal B

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by Ruijin Hospital:

Primary Outcome Measures:
  • Mortality [ Time Frame: 28day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • intra-abdominal Hypertension [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • respiratory failure [ Time Frame: 14days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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%.
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 Name: Ruijin pancreatitis goal
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 Name: Sepsis goal

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974466

Contacts
Contact: Zhen er Chen, PhD 64370045 ext 665520 chenerzhen@hotmail.com

Locations
China, Shanghai
Ruijin Recruiting
Shanghai, Shanghai, China, 20000
Contact: zhen er chen, PhD    64370045 ext 665570    clockming@live.com   
Principal Investigator: Zhen er chen, MD         
Sponsors and Collaborators
Ruijin Hospital
RenJi Hospital
Investigators
Study Director: Qiang En Mao, PhD Emergency intensive care unit of Ruijin Hospital
Study Chair: Ming zhong, MD doctor
  More Information

Publications:
Responsible Party: Erzhen Chen, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01974466     History of Changes
Other Study ID Numbers: RJpancreatitis01, RJpancreatitis01
Study First Received: October 26, 2013
Last Updated: November 18, 2013
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Ruijin Hospital:
pancreatitis
resuscitation goal

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 23, 2014