Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

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.

Study Overview

• Status: Unknown
• Conditions: Acute Pancreatitis; Complication of Ventilation Therapy
• Intervention / Treatment: Other: early mechanical Ventilation; Other: Conventional Mechanical Ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erzhen CHEN, MD; Phone Number: 86-13901753478; Email: chenerzhen@hotmail.com
• Study Contact Backup: Name: Enqiang MAO, MD; Phone Number: 86-13501747906

Study Locations

• China
  • Shanghai, China, 200025
    • Recruiting
    • Department of EICU, Ruijin Hospital
    • Contact: Erzhen CHEN, MD; Phone Number: 86-13901753478; Email: chenerzhen@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mechanical Ventilation Time	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
the incidence of ventilation associated pneumonia	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality		60 days
the incidence other complications of mechanical ventilation	patient-mechanic desynchronization, pneumothorax, atelectasis	participants will be followed for the duration of hospital stay, an expected average of 2 months
hospital stay		the participants will be followed till the discharge, an expected average of 2 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: mechanical ventilation; severe acute pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: SAP bundle -- MV; 12411950500 (Other Grant/Funding Number: Science and Technology Commission of Shanghai Municipality)