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Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)

This study has been completed.
Sponsor:
Collaborator:
Regione Piemonte
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00465309
First received: April 24, 2007
Last updated: January 9, 2009
Last verified: January 2009

April 24, 2007
January 9, 2009
April 2007
Not Provided
pulmonary inflammatory mediator reduction [ Time Frame: within the first 72 hours after enrollment ]
pulmonary inflammatory mediator reduction
Complete list of historical versions of study NCT00465309 on ClinicalTrials.gov Archive Site
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Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)
Not Provided

30% of ARDS patients ventilated according to NIH protocol presents morphological (CT) and functional (Stress Index>1) conditions of hyperinflation even with Plateau pressure (Pplat) < 30 cmH2O; values of Pplat lower than 26 cmH2O were associated with more a condition of more protective ventilation.

In patients at risk of hyperinflation, use of alternative techniques such as CO2-removal my allow the reduction of Tidal Volume (Vt) and Pplat.

Aim of the study was to verify the efficacy of CO2-removal technique in reducing Vt and consequently Pplat to obtain a Stress Index value equal to 1.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Adult Respiratory Distress Syndrome
Procedure: protective ventilation with CO2 removal technique
In ARDS patients, presenting a Pplat ≥ 26 cmH2O, Vt was lowered (reaching a Pplat < 26) with CO2-removal veno-venous pump-driven bypass support for 48 consecutive hours with a pH > 7,30 or at least 72 hours from the beginning of the extracorporeal treatment.
Not Provided
Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. Epub 2006 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
November 2008
Not Provided

Inclusion Criteria:

  • ARDS patients with Pplat >= 26 during NIH protective ventilation protocol

Exclusion Criteria:

  • Age < 18 years
  • Brain injury and patients with intracranial pressure > 20 mmHg
  • Pregnancy
  • Immunodepressed patients
  • Patients already enrolled in other trials
  • Renal replacement therapy
  • BMI > 40
  • Contraindication anticoagulation treatment
  • Morphological abnormalities of femoral veins
  • NYHA III-IV
  • Burns BSA>30%
  • Hepatic failure (grade C Child)
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00465309
PR60ANMA06
Not Provided
Marco Ranieri, University of Turin, Italy
University of Turin, Italy
Regione Piemonte
Study Director: V. M. Ranieri, MD University of Turin
Principal Investigator: P. Terragni, MD University of Turin
University of Turin, Italy
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP