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Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Erzhen Chen, Ruijin Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01974466
First Posted: November 1, 2013
Last Update Posted: November 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
Erzhen Chen, Ruijin Hospital
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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 Erzhen Chen, Ruijin Hospital:

Primary Outcome Measures:
  • Mortality [ Time Frame: 28day ]

Secondary Outcome Measures:
  • intra-abdominal Hypertension [ Time Frame: 7 days ]

Other Outcome Measures:
  • respiratory failure [ Time Frame: 14days ]

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Registry Identifier: RuijinH )
First Submitted: October 26, 2013
First Posted: November 1, 2013
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Erzhen Chen, Ruijin Hospital:
pancreatitis
resuscitation goal

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases