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Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Primary Purpose

Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Goal A
Goal B
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring pancreatitis, resuscitation goal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RuijinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Goal A

Goal B

Arm Description

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%.

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%

Outcomes

Primary Outcome Measures

Mortality

Secondary Outcome Measures

intra-abdominal Hypertension

Full Information

First Posted
October 26, 2013
Last Updated
November 18, 2013
Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01974466
Brief Title
Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis
Official Title
Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
pancreatitis, resuscitation goal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Goal A
Arm Type
Active Comparator
Arm Description
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%.
Arm Title
Goal B
Arm Type
Other
Arm Description
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%
Intervention Type
Other
Intervention Name(s)
Goal A
Other Intervention Name(s)
Ruijin pancreatitis goal
Intervention Description
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%.
Intervention Type
Other
Intervention Name(s)
Goal B
Other Intervention Name(s)
Sepsis goal
Intervention Description
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%
Primary Outcome Measure Information:
Title
Mortality
Time Frame
28day
Secondary Outcome Measure Information:
Title
intra-abdominal Hypertension
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
respiratory failure
Time Frame
14days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen er Chen, PhD
Phone
64370045
Ext
665520
Email
chenerzhen@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang En Mao, PhD
Organizational Affiliation
Emergency intensive care unit of Ruijin Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ming zhong, MD
Organizational Affiliation
doctor
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhen er chen, PhD
Phone
64370045
Ext
665570
Email
clockming@live.com
First Name & Middle Initial & Last Name & Degree
Zhen er chen, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19187641
Citation
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.
Results Reference
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Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

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