Handrup, M.M., Moller, J.K., & Schroder, H. (2013). Central venous catheters and catheter locks in children with cancer: A prospective randomized trial of taurolidine versus heparin. Pediatric Blood and Cancer, 60, 1292–1298.

DOI Link

Study Purpose

To determine if a taurolidine catheter lock can reduce catheter-related bloodstream infection (CRBSI) in children with tunneled central venous catheters (CVCs)

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either locks with 250 IE heparin in 2.5 ml normal saline or with 2.5 ml taurolidine 1.35%/sodium citrate 4%/heparin 100 IE/ml. Catheters were flushed once weekly. Catheter insertion was done according to standards in all patients, and bio-occlusive dressings were changed weekly after the skin was cleansed with chlorhexidine every three days. Tunneled lines and total implantable devices were included.

Sample Characteristics

  • N = 112 patients, 129 catheters  
  • MEDIAN AGE = 6 years
  • AGE RANGE = 0–19 years
  • MALES: 61%, FEMALES: 39%
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types; the most common was leukemia or lymphoma.
  • OTHER KEY SAMPLE CHARACTERISTICS: 113 of the 129 catheters were totally implantable devices.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified   
  • LOCATION: Denmark

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Pediatrics

Study Design

  • Randomized, two-group, open-label design

Measurement Instruments/Methods

  • Tunnel infection was defined as inflammation extending more than 2 cm along the tract of the CVC.
  • CRBSI was defined as growth of microbes from a sample drawn from the CVC at least two hours before microbial growth was detected in a peripheral blood sample, or cultures in which a pathogen was found in the central sample but not in the peripheral sample.
  • Probable CRBSI was determined if a recognized pathogen was cultured from at least one blood sample, or a common skin contaminant was cultured from two or more samples obtained at separate occasions.

Results

There were 33 episodes of CRBSI. The rate of total bloodstream infections per CVC days was seen in those with taurolidine locks (1.2 per 1,000 CVC days) compared to those with heparin locks (2.5 per 1,000 CVC days) (IRR = 0.49. p =.004). The rate of CRBSI in the experimental group was 0.4/1,000 CVC days compared to 1.4/1,000 CVC days (IRR = 0.26, p = .001). CVC survival was similar in both groups, with a median of 256 days in the heparin group and 300 days in the taurolidine group. Power analysis showed that the sample size was sufficient to detect a relative risk of 0.25 with the intervention.

Conclusions

Use of taurolidine citrate catheter locks was effective in preventing CRBSI in pediatric patients with long-term CVCs. The majority of these were totally implantable devices.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias(sample characteristics)
  • Other limitations/explanation: Open-label design; the majority of patients had totally implantable devices, so it is not clear if findings would apply similarly to only tunneled catheters.

Nursing Implications

CRBSI is a major concern for patients with cancer who are immunocompromised. Results of this study provide an intervention that appears to prevent CVC-related infections with long term CVCs. Because the majority of catheters in this study were totally implantable devices, it is not clear if this will apply to other long- or short-term CVCs, but further study in these areas is warranted.