Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreatitis

Keywords

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pancreatitis resuscitation goal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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%.

Group Type ACTIVE_COMPARATOR

Goal A

Intervention Type OTHER

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: 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%

Group Type OTHER

Goal B

Intervention Type OTHER

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%

Interventions

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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%.

Intervention Type 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%

Intervention Type OTHER

Other Intervention Names

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Ruijin pancreatitis goal Sepsis goal

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Erzhen Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang En Mao, PhD

Role: STUDY_DIRECTOR

Emergency intensive care unit of Ruijin Hospital

Ming zhong, MD

Role: STUDY_CHAIR

doctor

Locations

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Ruijin

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhen er Chen, PhD

Role: CONTACT

Phone: 64370045

Email: [email protected]

Facility Contacts

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zhen er chen, PhD

Role: primary

References

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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.

Reference Type BACKGROUND

PMID: 19187641 (View on PubMed)

Other Identifiers

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RJpancreatitis01

Identifier Type: REGISTRY

Identifier Source: secondary_id

RJpancreatitis01

Identifier Type: -

Identifier Source: org_study_id

Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Goal A

Goal A

Goal B

Goal B

Interventions

Goal A

Goal B

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

RenJi Hospital

Ruijin Hospital

Responsible Party

Erzhen Chen

Principal Investigators

Qiang En Mao, PhD

Ming zhong, MD

Locations

Ruijin

Countries

Central Contacts

Zhen er Chen, PhD

Facility Contacts

zhen er chen, PhD

References

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.

Other Identifiers

RJpancreatitis01

RJpancreatitis01