NCT01992224

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.9 years

First QC Date

November 6, 2013

Last Update Submit

November 18, 2013

Conditions

Acute PancreatitisComplication of Ventilation Therapy

Keywords

severe acute pancreatitismechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Mechanical Ventilation Time

    28 days

Secondary Outcomes (1)

  • the incidence of ventilation associated pneumonia

    28 days

Other Outcomes (3)

  • mortality

    60 days

  • the incidence other complications of mechanical ventilation

    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

Study Arms (2)

early mechanical ventilation

EXPERIMENTAL

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

conventional mechanical ventilation

EXPERIMENTAL

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

Interventions

early mechanical VentilationOTHER

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

early mechanical ventilation
Conventional Mechanical VentilationOTHER

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

conventional mechanical ventilation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of EICU, Ruijin Hospital

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

Erzhen CHEN, MD

CONTACT

86-13901753478chenerzhen@hotmail.com

Enqiang MAO, MD

CONTACT

86-13501747906

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 25, 2013

Study Start

July 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

CN(1)