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Congenital DisordersNCT00366314

Frequency of Accessing Central Lines for Blood Samples

An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to quantify and analyze the line accesses for each of the 3 participating ICUs. The hypothesis is that the CICU will have a significantly higher number of line accesses than the other units. Read more about this study

Who is it for?
Ages 30 days to 18 years
Conditions the study is for
Congenital Disorders
How many people
320 participants
Where
1 siteUnited States
Study dates
Jun 2003to not given
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 30 days to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • ICUs at Egleston Hospital, Children's Healthcare of Atlanta
  • June 1, 2003 - June 30, 2006
  • ICU LOS between 14 and 28 days
  • Central access
  • 30 days to 18 years

Who cannot join

  • Those who do not meet inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Frequency of Accessing Central Lines for Blood Samples and Medication Administration: A Comparison Between CICU, PICU and NICU

The purpose of this study is to quantify and analyze the line accesses for each of the 3 participating ICUs.

The hypothesis is that the CICU will have a significantly higher number of line accesses than the other units. Analyzing the data will assist the researchers in identifying best practices and ultimately, reduce the BSI rate in the CICU.

Read the detailed description

The CICU is participating in the system wide initiative to decrease blood stream infections (BSIs). In January 2006, the BSI rate in the CICU at Children's, Egleston peaked at 18.2 (rate of infections per 1000 catheter days). The BSI Bundles (processes of care) were rolled out on January 16, 2006 according to CHCA guidelines (Child Health Corporation of America). The Children's February BSI rate remained high at 16.3 despite the bundle implementation. The target goal is to maintain a rate below 3.7 which was realized only in March with a rate of 3.4. Subsequent months were 5.4 and 4.9. (See attached graph).

A separate research study is currently being conducted by Nicole Jarrell, in collaboration with Drs. Kevin Maher and Agustin Rubio, to determine risk factors for contracting a BSI by analyzing the past 200 infections (positive blood cultures) in the CICU. Preliminary findings in this study indicate a particularly high risk patient population, those with delayed sternal closures (open chests).

Results from this study indicate that of the 95 patients (January, 2004-February, 2006) with open chests, 28 developed BSIs (29.5%). This was compared to neonates undergoing cardiac bypass surgery with closed chests. This patient population had a significantly lower BSI rate at 9.1% (n=9 of 99). The largest subset of patients in these groups are the neonates with HLHS (Hypoplastic Left Heart Syndrome) undergoing the Norwood procedure. Upon reviewing all HLHS/Norwood patients, those with open chests (N=40) have a 32.5% infection rate compared to the closed chests (N=20) at 20%.

Multiple risk factors are assumed to contribute to the high risk and rate of infection in the CICU patient population. One risk that has been substantiated during a quality improvement project conducted in the CICU is related to accessing lines. The number of times that the patient's central and arterial lines are entered for blood sampling and medication administration was analyzed utilizing chart review of a small sample group of CICU patients (n=29). For these 29 patients, their lines were accessed 5476 times during their CICU LOS (length of stay). The average CICU LOS was 7.4 days. Of the 29 patients, 3 had open chests with an average duration of 7 days open.

The average times the line was accessed for the duration of LOS was 189 times at a rate of 13 per shift. When the patient LOS was >5 days (n=11 with an average LOS of 16 days), the total average increased to 455 times during the LOS, but per shift averages remained the same at 13.

This preliminary data indicates that the frequency of accessing lines in the CICU is a significant risk factor for cardiac ICU patients for acquiring a BSI.

Benchmarking of BSI rates against the other ICUs (PICU and NICU at Egleston) indicate the CICU has the highest infection rate of the ICUs. First quarter mean rates are as follows:

  • CICU=12.9
  • NICU=2.9
  • PICU=0

Differences in demographics of high risk patients are a factor in the differentiation between the units, however, there are also known specific differences in practice. Further analysis of specific practices related to minimizing infection risks are necessary to determine the best practices. This includes the frequency and specific reasons for accessing patients' central lines which is the focus of this study.

One primary difference in practice is related to the use of additional respiratory monitoring which allows for reduction in the number of blood samples for blood gas analysis. Another significant difference is in the utilization of medication drips instead of bolus medications, thus reducing the number of times the line is entered to administer medications. Although these practice differences are known, the actual impact on the patient by reducing the number of accesses to the lines and therefore reducing the risk of BSI, is unknown.

Keywords
Blood samples, Medication administration, CICU, PICU, NICU
Medical subject headings
Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2006 (estimated)
  2. Study startJun 2003

Resources

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
Defined population
Time perspective
Retrospective
Enrolment
320 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00366314
Sponsor's protocol ID
06-142
Status last verified
Jun 2007
First submitted
17 Aug 2006
Last updated
13 Jun 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.

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 5 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: stopped early, as of the sponsor's last update on 13 Jun 2007. 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 United States. 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?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
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 13 Jun 2007.

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