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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00263146
Other study ID # ARAMIS
Secondary ID
Status Terminated
Phase N/A
First received December 5, 2005
Last updated January 13, 2017
Start date September 2005
Est. completion date January 2006

Study information

Verified date February 2010
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

- aplasia

- HIV or CHV infection

- use of more than 0.5 mg/kg of steroïds

- immunosuppressor agents

- hemopathy

- contra indications for BAL

- contra indications for recruitment maneuvers

- baro-traumatism

- left cardiac failure

- chronic respiratory failure

- inclusion in another study during the past month

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
recruitment maneuver


Locations

Country Name City State
France University Hospital of Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary proteasis activity as measured in broncho alveolar fluid (BAL)
Primary pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood.
Secondary gaz exchange
Secondary respiratory mechanics
Secondary systemic hemodynamics
Secondary visceral dysfunction scores.
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