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Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

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.
 
ClinicalTrials.gov Identifier: NCT01992224
Recruitment Status : Unknown
Verified November 2013 by Erzhen Chen, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Erzhen Chen, Ruijin Hospital

Brief Summary:
Acute lung injury (ALI) and acute respiratory distress syndrome(ARDS) represent the most common and earliest organ dysfunction in acute pancreatitis, presenting as dyspnea and intractable hypoxemia, with secondary bilateral pulmonary infiltrates on radiograph. And mechanical ventilation (MV) is the essential intervention to improve oxygenation. When to initiate MV remains uncertain. In this study, we aim to compare the effect of early MV and conventional MV, and we hypothesize that early MV may be a better treatment option.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Complication of Ventilation Therapy Other: early mechanical Ventilation Other: Conventional Mechanical Ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis
Study Start Date : July 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: early mechanical ventilation

Fulfillment of three or more criteria below:

respiratory rate > 28 per minute serum lactate > 3 mmol/L PaO2/FiO2 Index <300 mmHg SvO2 < 65% lung infiltration or atelectasis, pleural exudation

Abbreivation: PaO2, arterial partial pressure of oxygen; FiO2, fraction of inspired oxygen; SvO2, venous oxygen saturation

Other: early mechanical Ventilation

Fulfillment of three or more criteria below:

respiratory rate > 28 per minute serum lactate > 3 mmol/L PaO2/FiO2 Index <300 mmHg SvO2 < 65% lung infiltration or atelectasis, pleural exudation


Experimental: conventional mechanical ventilation
other group who don't start early mechanical ventilation and fulfillment four criteria below: respiratory rate > 28 bpm dyspnea PaO2/FiO2 Index <200 mmHg Chest X-ray: lung infiltration exclude chronic heart failure and pulmonary disease
Other: Conventional Mechanical Ventilation
other group who don't start early mechanical ventilation and fulfillment four criteria below: respiratory rate > 28 bpm dyspnea PaO2/FiO2 Index <200 mmHg Chest X-ray: lung infiltration exclude chronic heart failure and pulmonary disease




Primary Outcome Measures :
  1. Mechanical Ventilation Time [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. the incidence of ventilation associated pneumonia [ Time Frame: 28 days ]

Other Outcome Measures:
  1. mortality [ Time Frame: 60 days ]
  2. the incidence other complications of mechanical ventilation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
    patient-mechanic desynchronization, pneumothorax, atelectasis

  3. hospital stay [ Time Frame: the participants will be followed till the discharge, an expected average of 2 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of pancreatitis:typical pain, increase in serum lipase or amylase, onset of abdominal pain within 72h before admission
  • The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012
  • the diagnosis of ARDS meets the criteria of Berlin definition

Exclusion Criteria:

  • chronic respiratory disease as chronic obstructive pulmonary disease (COPD), asthma
  • organic cardiopathy
  • pregnancy

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): NCT01992224


Contacts
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Contact: Erzhen CHEN, MD 86-13901753478 chenerzhen@hotmail.com
Contact: Enqiang MAO, MD 86-13501747906

Locations
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China
Department of EICU, Ruijin Hospital Recruiting
Shanghai, China, 200025
Contact: Erzhen CHEN, MD    86-13901753478    chenerzhen@hotmail.com   
Sponsors and Collaborators
Ruijin Hospital
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Responsible Party: Erzhen Chen, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01992224    
Other Study ID Numbers: SAP bundle -- MV
12411950500 ( Other Grant/Funding Number: Science and Technology Commission of Shanghai Municipality )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Erzhen Chen, Ruijin Hospital:
severe acute pancreatitis
mechanical ventilation
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases