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

A phase III randomised study to assess the risk of catheter-associated blood stream infections between the dominant and non-dominant arm in adults with cancer.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000870853

Acronym

CABSI

Enrollment

1250

Registered

2012-08-16

Start date

2012-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to assess whether the side of the body that a central venous line is inserted affects the risk of developing a bloodstream infection in cancer patients. Who is it for? You may be eligible to join this study if you are a cancer patient aged 15 years or above, who needs to have a central venous access device (CVAD) inserted. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will have the CVAD inserted into their dominant arm (i.e. right arm in right-handed people and left arm in left-handed people). Participants in the other group will have the CVAD inserted into their non-dominant arm. There will be no other change to treatment provided. Participants will be monitored to determine the incidence of catheter-associated bloodstream infection (CA-BSI) and catheter-related bloodstream infection (CR-BSI). This will enable us to find out whether the increased movement of the dominant arm might increase the risk of infection.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Provision of informed consent 2. Inpatients or outpatients with cancer who need to have a CVAD inserted

Exclusion criteria

1. Contraindication to CVAD insertion on one side of the body. This may include: * patients with breast cancer where there is a preference to insert CVADs in a particular side * prior line related thrombosis where there is a preference to insert CVADs in a particular side * prior difficult line insertion where there is a preference to insert CVADs in a particular side * any other medical reason where the patient’s physician or interventional radiologist believes that insertion on one side is contraindicated 2. Implantable ports will not be included in the study 3. Peripheral venous catheters are excluded

Outcome results