Blood Stream InfectionNCT03379948
Central and Peripheral Venous Catheters Associated Blood Stream Infection in ICU in Assiut University
An observational study of Blood Stream Infection, run by Assiut University at 1 site in Egypt.
Trial summary
Catheter related infections (CRIs) were found to be associated with several risk factors, including patient related risk factors such as age, gender, clinical status and catheter related risk factors such as the vascular access location, dwelling time, catheter type and number of lumens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Stream Infection
- What is being tested?
- blood culture
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Feb 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients presented to assiut university hospital admitted at intensive care unit
Who may be able to join
- All patient at ICU Diagnosed nosocomial infection
Who cannot join
- Patients exist already infected before admission at hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central and Peripheral Venous Catheters Associated Blood Stream Infection in the Critically Ill Patients in Assiut University Hospital
Catheter related infections (CRIs) were found to be associated with several risk factors, including patient related risk factors such as age, gender, clinical status and catheter related risk factors such as the vascular access location, dwelling time, catheter type and number of lumens. In addition to the inserted solution type and the experience of the professional who performs the procedure ,These factors constitute important strategic points for actions to compare the infectious complications of peripheral versus central venous catheters in critically ill patients.
Read the detailed description
Nosocomial (hospital-acquired) bloodstream infections (BSIs) are an important cause of morbidity and mortality, with an estimated 250,000 cases occurring each year in the United States.
BSIs may be either primary or secondary. Secondary infections are related to infections at other sites, such as the urinary tract, lung, postoperative wounds, and skin. Most nosocomial BSIs are primary, as illustrated by the United States Centers for Disease Control and Prevention's National Nosocomial Infection Surveillance system, in which 64 percent of the nosocomial BSIs reported were primary BSIs. While some primary BSIs have no identifiable source, most are associated with intravascular catheters, and central venous catheters (CVCs) in particular.
Critically ill patients require intravenous administration of fluids and drugs.This can be achieved via peripheral or central catheters. Each device is associated with both mechanical and infectious complications. Complications associated with central lines are judged to be more severe. Some patients actually require the insertion of a central line due to the venous toxicity of the drugs or to the necessity of making sure that the infusion is regularly administered (example: high dose catecholamine infusion). Some physicians believe that most Intensive Care Unit (ICU) patients should have a central venous line inserted, whereas others feel that some patients may receive active drugs via a peripheral line in selected instances.
Endpoints are the rate of mechanical complications (difficulty in inserting the line, need for repeat insertion attempts, occurrence of arterial puncture, occurrence of pneumothorax) and of infectious complications (local catheter infection or catheter-related bloodstream infection).
- Conditions
- Blood Stream Infection
- Being tested
- blood culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood cultureDiagnostic test
Also called complete blood count
blood culture to diagnose blood stream infection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 with central venous line | lab investigation Complete blood count blood culture Receives: Diagnostic Test: blood culture | |
| Group 2 with only peripheral line | lab investigation Complete blood count blood culture Receives: Diagnostic Test: blood culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the infectious complications of peripheral versus central venous catheters in critically ill patients
by blood sample
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Feb 2018 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Feb 2020 (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 Blood Stream InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Nassar Abd El Hameed Ali, Assiut University
- Investigators
- mohamed maghraby, MD, Study chair, ASSIUT UNIVERSTAY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379948
- Sponsor's protocol ID
- CAPVCABSIITCIPIAUH
- Status last verified
- Dec 2017
- First submitted
- 16 Dec 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: i wiil share it
Publications
Chen HS, Wang FD, Lin M, Lin YC, Huang LJ, Liu CY. Risk factors for central venous catheter-related infections in general surgery. J Microbiol Immunol Infect. 2006 Jun;39(3):231-6.
PubMed 16783454Timsit JF. [Updating of the 12th consensus conference of the Societe de Reanimation de langue francaise (SRLF): catheter related infections in the intensive care unit]. Ann Fr Anesth Reanim. 2005 Mar;24(3):315-22. doi: 10.1016/j.annfar.2004.12.022. French.
PubMed 15792575Holton D, Paton S, Conly J, Embree J, Taylor G, Thompson W. Central venous catheter-associated bloodstream infections occurring in Canadian intensive care units: A six-month cohort study. Can J Infect Dis Med Microbiol. 2006 May;17(3):169-76. doi: 10.1155/2006/781735.
PubMed 18418495Lorente L, Henry C, Martin MM, Jimenez A, Mora ML. Central venous catheter-related infection in a prospective and observational study of 2,595 catheters. Crit Care. 2005;9(6):R631-5. doi: 10.1186/cc3824. Epub 2005 Sep 28.
PubMed 16280064
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral Venous Catheters Associated Blood Stream Infection in the Critically Ill Patients in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT03379948
- Acronym / sponsor ID
- CAPVCABSIITCIPIAUH
- Conditions
- Blood Stream Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 20 Dec 2017 (actual)
- 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.
Catheter related infections (CRIs) were found to be associated with several risk factors, including patient related risk factors such as age, gender, clinical status and catheter related risk factors such as the vascular access location, dwelling time, catheter type and number of lumens. In addition to the inserted solution type and the experience of the professional who performs the procedure ,These factors constitute important strategic points for actions to compare the infectious complications of peripheral versus central venous catheters in critically ill patients.
Detailed description
Nosocomial (hospital-acquired) bloodstream infections (BSIs) are an important cause of morbidity and mortality, with an estimated 250,000 cases occurring each year in the United States.
BSIs may be either primary or secondary. Secondary infections are related to infections at other sites, such as the urinary tract, lung, postoperative wounds, and skin. Most nosocomial BSIs are primary, as illustrated by the United States Centers for Disease Control and Prevention's National Nosocomial Infection Surveillance system, in which 64 percent of the nosocomial BSIs reported were primary BSIs. While some primary BSIs have no identifiable source, most are associated with intravascular catheters, and central venous catheters (CVCs) in particular.
Critically ill patients require intravenous administration of fluids and drugs.This can be achieved via peripheral or central catheters. Each device is associated with both mechanical and infectious complications. Complications associated with central lines are judged to be more severe. Some patients actually require the insertion of a central line due to the venous toxicity of the drugs or to the necessity of making sure that the infusion is regularly administered (example: high dose catecholamine infusion). Some physicians believe that most Intensive Care Unit (ICU) patients should have a central venous line inserted, whereas others feel that some patients may receive active drugs via a peripheral line in selected instances.
Endpoints are the rate of mechanical complications (difficulty in inserting the line, need for repeat insertion attempts, occurrence of arterial puncture, occurrence of pneumothorax) and of infectious complications (local catheter infection or catheter-related bloodstream infection).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 with central venous line | – | Diagnostic Test: blood culturelab investigation Complete blood count blood culture |
| Group 2 with only peripheral line | – | Diagnostic Test: blood culturelab investigation Complete blood count blood culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presented to assiut university hospital admitted at intensive care unit
Key inclusion criteria (1 listed)
- All patient at ICU Diagnosed nosocomial infection
Key exclusion criteria (1 listed)
- Patients exist already infected before admission at hospital.
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 |
|---|---|---|
| blood cultureAlso: complete blood countblood culture to diagnose blood stream infection | Diagnostic test | Group 1 with central venous line, Group 2 with only peripheral line |
Primary outcome
compare the infectious complications of peripheral versus central venous catheters in critically ill patients
Time frame: 7 days
by blood sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Background: PubMed 16783454Chen HS, Wang FD, Lin M, Lin YC, Huang LJ, Liu CY. Risk factors for central venous catheter-related infections in general surgery. J Microbiol Immunol Infect. 2006 Jun;39(3):231-6.
- Background: PubMed 15792575Timsit JF. [Updating of the 12th consensus conference of the Societe de Reanimation de langue francaise (SRLF): catheter related infections in the intensive care unit]. Ann Fr Anesth Reanim. 2005 Mar;24(3):315-22. doi: 10.1016/j.annfar.2004.12.022. French.
- Background: PubMed 18418495Holton D, Paton S, Conly J, Embree J, Taylor G, Thompson W. Central venous catheter-associated bloodstream infections occurring in Canadian intensive care units: A six-month cohort study. Can J Infect Dis Med Microbiol. 2006 May;17(3):169-76. doi: 10.1155/2006/781735.
- Background: PubMed 16280064Lorente L, Henry C, Martin MM, Jimenez A, Mora ML. Central venous catheter-related infection in a prospective and observational study of 2,595 catheters. Crit Care. 2005;9(6):R631-5. doi: 10.1186/cc3824. Epub 2005 Sep 28.
- Individual participant dataSharing planned: Undecided. i wiil share it
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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.
mohamed maghraby, MD study chair
ASSIUT UNIVERSTAY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Stream Infection, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 27 Dec 2017. 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 Egypt. 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 mohamed maghraby, MD (01010685968, maghraby@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the infectious complications of peripheral versus central venous catheters in critically ill patients (time frame: 7 days). 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 NCT03379948, 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 27 Dec 2017.