Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

NCT ID: NCT01992224

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-06-30

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.

Conditions

Acute Pancreatitis; Complication of Ventilation Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

early mechanical Ventilation

Intervention Type: OTHER

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

Group Type: EXPERIMENTAL

Conventional Mechanical Ventilation

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Erzhen Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of EICU, Ruijin Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Erzhen CHEN, MD

Role: CONTACT

chenerzhen@hotmail.com

86-13901753478

Enqiang MAO, MD

Role: CONTACT

86-13501747906

Facility Contacts

Erzhen CHEN, MD

Role: primary

chenerzhen@hotmail.com

86-13901753478

Other Identifiers

12411950500

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SAP bundle -- MV

Identifier Type: -

Identifier Source: org_study_id