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Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Primary Purpose

Acute Pancreatitis, Complication of Ventilation Therapy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
early mechanical Ventilation
Conventional Mechanical Ventilation
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring severe acute pancreatitis, mechanical ventilation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of EICU, Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

early mechanical ventilation

conventional mechanical ventilation

Arm Description

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 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

Outcomes

Primary Outcome Measures

Mechanical Ventilation Time

Secondary Outcome Measures

the incidence of ventilation associated pneumonia

Full Information

First Posted
November 6, 2013
Last Updated
November 18, 2013
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01992224
Brief Title
Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis
Official Title
Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Complication of Ventilation Therapy
Keywords
severe acute pancreatitis, mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
early mechanical ventilation
Arm Type
Experimental
Arm Description
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
Arm Title
conventional mechanical ventilation
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
early mechanical Ventilation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Mechanical Ventilation
Intervention Description
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 Measure Information:
Title
Mechanical Ventilation Time
Time Frame
28 days
Secondary Outcome Measure Information:
Title
the incidence of ventilation associated pneumonia
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
mortality
Time Frame
60 days
Title
the incidence other complications of mechanical ventilation
Description
patient-mechanic desynchronization, pneumothorax, atelectasis
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 months
Title
hospital stay
Time Frame
the participants will be followed till the discharge, an expected average of 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erzhen CHEN, MD
Phone
86-13901753478
Email
chenerzhen@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Enqiang MAO, MD
Phone
86-13501747906
Facility Information:
Facility Name
Department of EICU, Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erzhen CHEN, MD
Phone
86-13901753478
Email
chenerzhen@hotmail.com

12. IPD Sharing Statement

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Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

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