Drug ContaminationNCT00757458
Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion
A study testing EDTA without re-filling, Propofol syringe re-filling with propofol containing EDTA and Re-filling of syringe with propofol without EDTA in people with Drug Contamination, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Contamination
- What is being tested?
- EDTA without re-filling, Propofol syringe re-filling with propofol containing EDTA and Re-filling of syringe with propofol without EDTA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age eighteen years old or more
- ASA Physiological Status P1 ou P2
- Patients undergoing clean procedure under general anesthesia.
Who cannot join
- Patients under eighteen years old
- ASA Physiological Status P3, P4 or P5
- Current infectious process
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade de Sao Paulo Hospital das Clinicas
São Paulo, São Paulo, 05403-000
About this study
Official title: Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion in Patients Undergoing General Anesthesia
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.
- Conditions
- Drug Contamination
- Being tested
- EDTA without re-filling, Propofol syringe re-filling with propofol containing EDTA, Target controlled infusion of propofol without EDTA, Re-filling of syringe with propofol without EDTA
- Keywords
- Propofol, Bacterial growth, Fungal growth, EDTA, Target controlled infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDTA without re-fillingDrug
Target controlled infusion of propofol containing EDTA (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca), without re-filling of syringe.
Propofol syringe re-filling with propofol containing EDTAOther
Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol containing EDTA.
Target controlled infusion of propofol without EDTAOther
Target controlled infusion of propofol without EDTA using Marshal´s technic with Alaris® or Fresenius® equipment
Re-filling of syringe with propofol without EDTAOther
Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol not containing EDTA.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | TCI with EDTA Receives: Drug: EDTA without re-filling |
| 2 | Active comparator | Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol containing EDTA Receives: Other: Propofol syringe re-filling with propofol containing EDTA |
| 3 | Active comparator | Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol without EDTA Receives: Other: Re-filling of syringe with propofol without EDTA |
| 4 | Active comparator | Target controlled infusion of propofol without EDTA Receives: Other: Target controlled infusion of propofol without EDTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Drug ContaminationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 652 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757458
- Sponsor's protocol ID
- EDTA-652
- Status last verified
- Sep 2008
- First submitted
- 22 Sep 2008
- Last updated
- 23 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jansson JR, Fukada T, Ozaki M, Kimura S. Propofol EDTA and reduced incidence of infection. Anaesth Intensive Care. 2006 Jun;34(3):362-8. doi: 10.1177/0310057X0603400305.
PubMed 16802492Fukada 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. doi: 10.1111/j.1365-2044.2007.05002.x.
PubMed 17506735Trepanier CA, Lessard MR. Propofol and the risk of transmission of infection. Can J Anaesth. 2003 Jun-Jul;50(6):533-7. doi: 10.1007/BF03018635. No abstract available. English, French.
PubMed 12826541Bennett 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. doi: 10.1056/NEJM199507203330303.
PubMed 7791816
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT00757458
- Acronym / sponsor ID
- EDTA-652
- Conditions
- Drug Contamination
- Keywords
- Propofol, Bacterial growth, Fungal growth, EDTA, Target controlled infusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 652 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 23 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: EDTA without re-fillingTCI with EDTA |
| 2 | Active comparator | Other: Propofol syringe re-filling with propofol containing EDTARe-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol containing EDTA |
| 3 | Active comparator | Other: Re-filling of syringe with propofol without EDTARe-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol without EDTA |
| 4 | Active comparator | Other: Target controlled infusion of propofol without EDTATarget controlled infusion of propofol without EDTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age eighteen years old or more
- ASA Physiological Status P1 ou P2
- Patients undergoing clean procedure under general anesthesia.
Key exclusion criteria (3 listed)
- Patients under eighteen years old
- ASA Physiological Status P3, P4 or P5
- Current infectious process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDTA without re-fillingTarget controlled infusion of propofol containing EDTA (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca), without re-filling of syringe. | Drug | 1 |
| Propofol syringe re-filling with propofol containing EDTATarget controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol containing EDTA. | Other | 2 |
| Target controlled infusion of propofol without EDTATarget controlled infusion of propofol without EDTA using Marshal´s technic with Alaris® or Fresenius® equipment | Other | 4 |
| Re-filling of syringe with propofol without EDTATarget controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol not containing EDTA. | Other | 3 |
Primary outcome
Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2008.
- Background: PubMed 16802492Jansson JR, Fukada T, Ozaki M, Kimura S. Propofol EDTA and reduced incidence of infection. Anaesth Intensive Care. 2006 Jun;34(3):362-8. doi: 10.1177/0310057X0603400305.
- Background: PubMed 17506735Fukada 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. doi: 10.1111/j.1365-2044.2007.05002.x.
- Background: PubMed 12826541Trepanier CA, Lessard MR. Propofol and the risk of transmission of infection. Can J Anaesth. 2003 Jun-Jul;50(6):533-7. doi: 10.1007/BF03018635. No abstract available. English, French.
- Background: PubMed 7791816Bennett 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. doi: 10.1056/NEJM199507203330303.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDTA without re-filling, Propofol syringe re-filling with propofol containing EDTA and Re-filling of syringe with propofol without EDTA in people with Drug Contamination, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Jose C Carmona, Professor (55-11-3069-5367, maria.carmona@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00757458, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2008.