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Clinical Trials/NCT00263146
NCT00263146
Terminated
Not Applicable

Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory (ARAMIS: Apport d'un Recrutement Alveolaire Sur Les Marqueurs de l'Inflammation Dans le SDRA)

University Hospital, Tours1 site in 1 country30 target enrollmentSeptember 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Lung Injury
Sponsor
University Hospital, Tours
Enrollment
30
Locations
1
Primary Endpoint
proteasis activity as measured in broncho alveolar fluid (BAL)
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

Acute Respiratory Distress Syndrom is associated to lung and systemic inflammation, which could be worsened by mechanical ventilation.This included a proteasis - antiproteasis imbalance which could participate to a fibrosis process.

Low tidal-volume ventilation (6 mL/kg) with low plateau pressure (< 30 cm H2O) has been proved to decrease mortality when compared with more conventionnal high-volume (12 mL/kg) ventilation.Moreover, this lung-protective approach decrease lung annd systemic inflammation.

Using recruitment maneuvers (i.e. the application during a short time of high pressures with the intention to re-open the lung, followed by an increase of PEEP-level to keep the lung open, in an attempt to decrease the alveolar shear-stress) has been proposed to improve oxygen and to reduce bio-trauma.

However, the effect of such maneuvers on the inflammatory response and on the evolution of ARDS remains unknown.

Therefore we have planned a randomized, monocentric, controlled trial consisting of the comparison of two approaches of mechanical ventilation in Acute Lung Injury. This trial will include 30 hemodynamically stable patients fulfilling the ALI or ARDS criteria defined by the US and European Consensus Conference.

They will be randomized in two groups: standard low-volume ventilation vs. recruitment maneuvers.

The main objective of our study is to compare both ventilatory strategies in termes of lung and systemic inflammation.

The primary outcome measures will be the proteasis activity as measured in broncho alveolar fluid (BAL) and pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood. Two samples (BAL and blood) will be obtained at a 48-72 hours interval. In the recruitment maneuver group, the first BAL will be obtained two hours before the maneuver.

Secondary outcome measures will be gaz exchange, respiratory mechanics, systemic hemodynamics and visceral dysfunction scores.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
January 2006
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • age over 18
  • hospitalization in the ICU
  • under mechanical ventilation
  • Acute Lung Injury (ALI)criteria
  • first week of ALI
  • hemodynamic stability (mAP \> 75 mmHg since one hour)
  • informed consent signed (patient or relatives)

Exclusion Criteria

  • pregnancy
  • obesity (BMI \> 40 kg/M2)
  • high probability of D-28 death
  • severe burn injury
  • severe hepatic cirrhosis (Child-Pugh C)
  • HIV or CHV infection
  • use of more than 0.5 mg/kg of steroïds
  • immunosuppressor agents
  • hemopathy
  • contra indications for BAL

Outcomes

Primary Outcomes

proteasis activity as measured in broncho alveolar fluid (BAL)

pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood.

Secondary Outcomes

  • gaz exchange
  • respiratory mechanics
  • systemic hemodynamics
  • visceral dysfunction scores.

Study Sites (1)

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