Catheter-associated bloodstream infections in adults with cancer: A prospective randomised controlled trial.

Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: The intervention is the randomisation to insert the central venous access device (CVAD) to either side of the body. The comparison is between two interventions of dominant or non‐dominant side of the body. CONDITION: Catheter‐associated blood stream infection in cancer patients PRIMARY OUTCOME: CA‐BSI is defined according to the Australian Infection Control Association (Auricht, 2001) based on criteria from the National Nosocomial Infections Surveillance System from the CDC Atlanta, USA (Gaynes, 1996) and from the Public Health Laboratory Service of the UK (Glynn, 1997). CA‐BSI are identified when: (a) the patient had a recognised pathogen isolated from one or more blood cultures (e.g. Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Klebsiella species, Proteus species, Candida albicans); or (b) the patient had at least one of the following signs and symptoms within 24 hours of a positive blood culture being collected (fever > 38 degrees celsius, chills, rigors, hypotension), and at least one of the following: isolation of a common skin commensal (e.g. diptheroids, coagulase negative staphylococci, Micrococcus sp, Propionbacterium species, Bacillus species) from two or more blood culture sets drawn on separate occasions within a 48 hour period; or isolation of a common skin contaminant from a single blood culture and appropriate antimicrobial therapy is commenced. In addition to (a) and (b) above, the CVAD must have been present within 48 hours of the event and the organism must not be related to an infection at another site. When first detected, all positive blood culture results will be communicated by telephone to the treating physician by the laboratory staff and likely relationship to any intravenous line documented. In the event of multiple episodes of positive cultures during the lifespan of a single CVAD, the first episode of CA‐BSI will be regarded as the single CA‐BSI episode for the purposes of this study. SECONDARY OUTCOME: A secondary hypothesis is that insertion of CVAD into the non‐dominant side of haematology‐oncology patients will reduce the risk of catheter related bloodstream infection (CR‐BSI) compared to insertion of CVAD into the dominant side. CR‐BSI (Mermel, 2009) is defined as per CA‐BSI but with additional isolation of the same organism from culture of the CVAD tip (roll tip method (Maki, 1977)) or growth of microbes from a blood sample drawn from a catheter hub at least 2 h before microbial growth is detected in a blood sample obtained from a peripheral vein (differential time to positivity criteria) (Mermel, 2009). INCLUSION CRITERIA: 1. Provision of informed consent 2. Inpatients or outpatients with cancer who need to have a CVAD inserted
Epistemonikos ID: 226b1e6162ee8af3271eaa2fdd5db4bc4294d6a5
First added on: Aug 22, 2024