Keystone ICU Project

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Pronovost P, et al. "An intervention to decrease catheter-related bloodstream infections in the ICU". The New England Journal of Medicine. 2006. 355(26):2725-32.
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Clinical Question

Among ICU patients, does placement of central lines using a standardized protocol reduce rates of catheter-related bloodstream infections?

Bottom Line

Among ICU patients, placement of central lines using a standardized protocol reduces rates of catheter-related bloodstream infections.

Major Points

Catheter-related blood stream infections (CRBSI) can be devastating when they occur and often are iatrogenic. In the USA alone annually there were over a quarter million preventable catheter related blood stream infections. These can lead to increased costs, length of stay, exposure to antimicrobials, and the catastrophic outcome of death.

The ICU Keystone project was implemented to improve patient safety within the state of Michigan, USA. The CRBSI reduction intervention of this trial was implemented as part of a bundle of with three other patient safety interventions:

  • daily goals sheet to improve clinician-to-clinician communication within the ICU
  • intervention to reduce the incidence of ventilator-associated pneumonia14[1]
  • comprehensive unit-based safety program to improve the safety culture[2][3]
  • CRBSI intervention:
    • hand washing
    • using full-barrier precautions during the insertion of central venous catheters
    • cleaning the skin with chlorhexidine
    • avoiding the femoral site if possible, and
    • removing unnecessary catheters.

The intervention demonstrated a reduction in the rate of infection from 2.7/1000 catheter days to 0/1000 catheter days (P≤0.05) at 3 months post implementation, which was sustained out to 18 months. The incidence rate-ratio showed a statistically significant decrease over the same time frame. Attempting to conduct a trial of this nature in a blinded fashion would be impossible; doing a sham procedure likely wouldn't "fool" the bacteria. Using historical comparisons within the same institution allows the culture of each institution to cancel itself out as a variable and having a short interval between comparison and intervention tracking decreases other cultural shifts in practice to influence and bias the outcomes.

Since this trial, the use of these five evidence based interventions as well as several others has been widely accepted to decrease the preventable iatrogenic infections. The other interventions included may have different uptake depending on the culture of the given institution.


The findings from this trial are reflected in:

  • CDC's Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011 [4],
  • Guidelines for the Prevention of Intravascular Catheter-Related Infections: Recommendations Relevant to Interventional Radiology for Venous Catheter Placement and Maintenance, 2012 [5], and
  • APSIC guide for prevention of Central Line Associated Bloodstream Infections (CLABSI), 2016 [6]


  • Prospective, Cohort trial
  • N=103 ICU's
  • Setting: Michigan, USA
  • Enrollment: March 2004-September 2005
  • Follow-up: 18 months
  • Primary outcome: Rate of Catheter-Related Bloodstream Infection


Inclusion Criteria

ICU's in institutions in Michigan, USA

  • Included 5 institutions outside of the state that had their headquarters in Michigan

Exclusion Criteria

  • Non-compliance with tracking CRBSI

Baseline Characteristics

Presented as ICU's, Number of Infections(Range), Catheter days(IRQ) [Number infections per 1000 Catheter days]

  • All hospitals: 100%, 2(1–3), 511(220–1091),[2.7(0.6–4.8)]
  • Teaching status
    • Teaching: 60%, 2(1–4), 744(377–1134) [2.7(1.3–4.7)]
    • Nonteaching: 40%, 1(0–2), 306(194–608), [2.6(0–4.9)]
  • No. of beds
    • < 200: 13, 1(0–1), 247(75–377), [2.1(0–3.0)]
    • 200–299: 12, 2(1–6), 595(338–1670), [3.2(0.3–4.3)]
    • 300–399: 12, 2(1–3), 902(184–1376), [2.7(1.7–5.8)]
    • ≥ 400: 18, 2(1–3), 616(424–1102), [2.0(1.3–4.7)]


Implementation of recommendations by the CDC to reduce Central Line infections[7]:

  • hand washing
  • using full-barrier precautions during the insertion of central venous catheters
  • cleaning the skin with chlorhexidine
  • avoiding the femoral site if possible, and
  • removing unnecessary catheters.


Median rates presented. P-values are in comparison to baseline rate.

Primary Outcome

Baseline: 2.7/1000 catheter-days
0-3 months: 0/1000 catheter days (P≤0.05)

Secondary Outcomes

CLABSIs beyond 3 months
4-6 months: 0/1000 catheter days (P≤0.002)
7-9 months: 0/1000 catheter days (P≤0.002)
10-12 months: 0/1000 catheter days (P≤0.002)
13-15 months: 0/1000 catheter days (P≤0.002)
16-18 months: 0/1000 catheter days (P≤0.002)

Subgroup Analysis

Incidence-Rate Ratios for Catheter-Related Bloodstream Infections, Incidence-Rate Ratio(95% CI)
Baseline: 1.00
0-3 months: 0.62(0.47–0.81)(P=0.001)
4-6 months: 0.56(0.38–0.84)(P=0.005)
7-9 months: 0.47(0.34–0.65)(P<0.001)
10-12 months: 0.42(0.28–0.63)(P<0.001)
13-15 months: 0.37(0.20–0.68)(P=0.001)
16-18 months: 0.34(0.23–0.50)(P<0.001)
Teaching Hospital: 1.34(0.73–2.46)(P=0.35)
Bed size (per 100 beds): 1.03(0.97–1.09)(P=0.33)


  • Selection bias may have occurred due to the self-selection of participation
  • Effect size may be over-estimated due to historical comparisons
  • Effect size may be over-estimated due to interference from the other interventions in the Patient Safety bundle
  • Replicating this study in other areas, both of the country and internationally due to cultural differences may affect external validity
  • With non-blinding of the infectious control practitioner in the design, observer bias may have occurred


Funded by the Agency for Healthcare Research and Quality (AHRQ) which funded the whole Michigan Health and Hospi- tal Association (MHA) Keystone Center for Patient Safety and Quality Keystone ICU project

Further Reading