Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00757458
• Collaborator: AstraZeneca (Industry)
• Enrollment: 652
• Location: 1
• Arms: 4
• Duration (Months): 12
• Patients Per Site Per Month: 54.4

Study Details

Study Description

Brief Summary

The purpose of this study is to verify the existence of bacterial and/or fungal contamination during different technics of propofol with or without EDTA continuous infusion in patients undergoing general anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Drug Contamination	Drug: EDTA without re-filling; Other: Propofol syringe re-filling with propofol containing EDTA; Other: Target controlled infusion of propofol without EDTA; Other: Re-filling of syringe with propofol without EDTA	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 652 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion in Patients Undergoing General Anesthesia
• Study Start Date: Dec 1, 2008
• Anticipated Primary Completion Date: Jun 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 TCI with EDTA	Drug: EDTA without re-filling; Target controlled infusion of propofol containing EDTA (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca), without re-filling of syringe.
Active Comparator: 2 Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol containing EDTA	Other: Propofol syringe re-filling with propofol containing EDTA; Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol containing EDTA.
Active Comparator: 3 Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol without EDTA	Other: Re-filling of syringe with propofol without EDTA; Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol not containing EDTA.
Active Comparator: 4 Target controlled infusion of propofol without EDTA	Other: Target controlled infusion of propofol without EDTA; Target controlled infusion of propofol without EDTA using Marshal´s technic with Alaris® or Fresenius® equipment

Outcome Measures

Primary Outcome Measures

1. Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age eighteen years old or more

• ASA Physiological Status P1 ou P2

• Patients undergoing clean procedure under general anesthesia.

Exclusion Criteria:

• Patients under eighteen years old

• ASA Physiological Status P3, P4 or P5

• Current infectious process

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade de Sao Paulo Hospital das Clinicas	Sao Paulo		Brazil	05403-000

Sponsors and Collaborators

• University of Sao Paulo
• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bennett SN, McNeil MM, Bland LA, Arduino MJ, Villarino ME, Perrotta DM, Burwen DR, Welbel SF, Pegues DA, Stroud L, et al. Postoperative infections traced to contamination of an intravenous anesthetic, propofol. N Engl J Med. 1995 Jul 20;333(3):147-54.
• Fukada T, Ozaki M. Microbial growth in propofol formulations with disodium edetate and the influence of venous access system dead space. Anaesthesia. 2007 Jun;62(6):575-80.
• Jansson JR, Fukada T, Ozaki M, Kimura S. Propofol EDTA and reduced incidence of infection. Anaesth Intensive Care. 2006 Jun;34(3):362-8. Review.
• Trépanier CA, Lessard MR. Propofol and the risk of transmission of infection. Can J Anaesth. 2003 Jun-Jul;50(6):533-7. English, French.

• ClinicalTrials.gov Identifier: NCT00757458
• Other Study ID Numbers: EDTA-652
• First Posted: Sep 23, 2008
• Last Update Posted: Sep 23, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: Propofol; Bacterial growth; Fungal growth; EDTA; Target controlled infusion
• Additional relevant MeSH terms: Propofol; Edetic Acid; Pentetic Acid

Study Results

No Results Posted as of Sep 23, 2008