Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01992224
• Other study ID #: SAP bundle -- MV
• Secondary ID: 12411950500
• Status: Recruiting
• Phase: N/A
• First received: November 6, 2013
• Last updated: November 18, 2013
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: November 2013
• Source: Ruijin Hospital
• Contact: Erzhen CHEN, MD
• Phone: 86-13901753478
• Email: chenerzhen[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Complication of Ventilation Therapy
• Pancreatitis

Intervention

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
• 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

Locations

Country	Name	City	State
China	Department of EICU, Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mortality		60 days	Yes
Other	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	Yes
Other	hospital stay		the participants will be followed till the discharge, an expected average of 2 months	Yes
Primary	Mechanical Ventilation Time		28 days	Yes
Secondary	the incidence of ventilation associated pneumonia		28 days	Yes