Use of ethanol to prevent infection in tunnelled intravenous catheters in haematology patients treated with chemotherapy.

A Prospective double-blind randomised clinical trial of 70% ethanol to prevent luminal microbial colonisation of tunneled catheters and associated catheter related sepsis, in haematology patients treated with chemotherapy.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000383662

Enrollment

100

Registered

2005-09-13

Start date

2002-01-03

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

Interventions

To assess the efficacy ans safety of 70% ethanol in preventing luminal colonisation of central venous tunnelled catheters. 70% Ethanol or Heparin/saline will be installed into the lumen of the catheter daily for a duration of 2 hours before being removed. This intervention will continue for the length of the hospital admission for the patient or to a limit of 30 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Consent. Central venous catheter in-situ For chemotherapy requiring an in-patient stay for >5 days. Haematological malignancy / Bone marrow transplant.

Exclusion criteria

Known allergy to ethanol. Out-patient chemotherapy. Positive central line cultures within 7 days of entry into study. Elevated LFTs (>2.5 times above ULN). Known history of alcoholism. Pregnancy/lactating women Febrile above 38.0deg at entry.

Outcome results