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Pravastatin and Ventilatory Associated Pneumonia (EPRAVAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Efstratios Manoulakas, University of Thessaly
ClinicalTrials.gov Identifier:
NCT00702130
First received: June 19, 2008
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

Statins present anti-inflammatory and immunomodulatory effects. They may modify the regulation of cytokines, (released from the cellular damage) and may reduce the production of C-reactive protein levels. It has been hypothesized that these pleiotropic characteristic of statins might be useful in the management of various diseases, including pneumonia. Indeed, a recent study showed that statin treatment is associated with reduced risk of pneumonia in diabetic patients. However, the relationship between statins and reduced risk of pneumonia is not consistent . In addition there is no prospective study to investigate the role of statins in severe forms of pneumonia such as the VAP.

On this base the investigators aim to study prospectively the effect of statins on the outcome of patients with VAP in the ICU settings. The investigators therefore contacted a double open label randomized trial to investigate whether the use of pravastatin reduces the incidence of Ventilator Associated Pneumonia in the ICU and whether it is related with favorable outcome of patients with Ventilator Associated Pneumonia.


Condition Intervention Phase
Ventilator Associated Pneumonia
Drug: Pravastatin
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Pravastatin on the Incidence and in the Natural Course of Ventilatory Associated Pneumonia in the Intensive Care Unit Patients

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • Length of hospitalization in the Intensive Care Unit, morbidity in the Intensive Care Unit [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severity of Ventilator Associated Pneumonia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: June 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
this arm will receive Pravastatin 40 mg per os daily
Drug: Pravastatin
pravastatin 40mg per os once daily
No Intervention: 1

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence in Intensive Care Unit

Exclusion Criteria:

  • Pregnancy,
  • Pneumonia, previous use of statins,
  • Contraindications to statin use (liver dysfunction, SGOT/SGPT > 100 U/L),
  • Increased CPK (over 3 times the upper limit), (for non trauma patients) on admission,
  • Increase of CPK (over 5 times the upper limit) during hospitalization,
  • Use of substances that contraindicates simultaneous use of statins (macrolides, cyclosporine, antipyrin, cholestyramine, gemfibrosil, warfarin),
  • Malabsorption syndrome (over the first 48 hours).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00702130

Locations
Greece
General Hospital Larissa
Larissa, Thessalia, Greece, 41221
Zakynthinos E. Dir-University Hospital Larisa
Mezourlo / Larissa, Greece, 41110
Sponsors and Collaborators
University of Thessaly
  More Information

No publications provided

Responsible Party: Efstratios Manoulakas, Ph, University of Thessaly
ClinicalTrials.gov Identifier: NCT00702130     History of Changes
Other Study ID Numbers: 310UT
Study First Received: June 19, 2008
Last Updated: November 29, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by University of Thessaly:
Ventilator Associated Pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Cross Infection
Infection
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Respiratory Tract Infections
Ventilator-Induced Lung Injury
Pravastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014