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Central and Peripheral Venous Catheters Associated Blood Stream Infection in ICU in Assiut University

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ClinicalTrials.gov Identifier: NCT03379948
Recruitment Status : Not yet recruiting
First Posted : December 20, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Shaimaa Nassar Abd El Hameed Ali, Assiut University

Brief 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. 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.

Condition or disease Intervention/treatment
Blood Stream Infection Diagnostic Test: blood culture

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).


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Central and Peripheral Venous Catheters Associated Blood Stream Infection in the Critically Ill Patients in Assiut University Hospital
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2020

Group/Cohort Intervention/treatment
Group 1 with central venous line
lab investigation Complete blood count blood culture
Diagnostic Test: blood culture
blood culture to diagnose blood stream infection
Other Name: complete blood count

Group 2 with only peripheral line
lab investigation Complete blood count blood culture
Diagnostic Test: blood culture
blood culture to diagnose blood stream infection
Other Name: complete blood count




Primary Outcome Measures :
  1. compare the infectious complications of peripheral versus central venous catheters in critically ill patients [ Time Frame: 7 days ]
    by blood sample



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients presented to assiut university hospital admitted at intensive care unit
Criteria

Inclusion Criteria:

  • All patient at ICU Diagnosed nosocomial infection

Exclusion Criteria:

  • Patients exist already infected before admission at hospital.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379948


Contacts
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Contact: mohamed maghraby, MD 01010685968 maghraby@gmail.com
Contact: Hassan mekawy 01285569023 mekawy@gmail.com

Locations
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Egypt
Assiut Universtay Hospital Not yet recruiting
Assiut, Egypt
Contact: mohamed emad, master         
Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: mohamed maghraby, MD ASSIUT UNIVERSTAY

Additional Information:

Publications:
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Responsible Party: Shaimaa Nassar Abd El Hameed Ali, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03379948     History of Changes
Other Study ID Numbers: CAPVCABSIITCIPIAUH
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: i wiil share it

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases