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Results summary of St. Jude clinical trial: 

ETHEL

 
 

Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection (ETHEL)

Why was this study done?

Central venous lines and ports make cancer treatment much easier, but they increase the chances of getting blood infections. A line infection occurs when bacteria or fungus attach to the line. Children with these infections generally have to stay in the hospital and receive antibiotics or antifungals to help clear the infection. But, sometimes it is not possible to clear the infection, or the infection returns after treatment. Once a child has a line infection, the chance of getting another one is much higher.

We wanted to find out if we could improve the chance of curing current line infections and preventing others by using a treatment called ethanol lock therapy or ELT. Ethanol works to kill germs that might cause an infection. ELT involves injecting a solution of ethanol and water into the line or port. After a dwell period, the solution is removed.

The study’s main goals were to:

  • See if giving ethanol locks could improve central line infection outcomes by reducing the number of people who had their lines removed or had recurrence of the infection.

When was this study done?

The study opened in December 2011 and closed in November 2016.

What did the study consist of?

Patients took part in the study for about nine months, including five days in the “treatment” part, six months in the “prevention” part and up to 90 days in the “follow-up” part. 

Treatment included:

  • Ethanol or heparin-saline lock-therapy each day
  • A blood culture every day for 5 days to check for bacteria in the blood
  • A test to measure the level of ethanol in the blood   

Prevention included:

  • For patients with Hickman or Broviac lines: lock-therapy three times a week
  • For patients with ports: lock-therapy only when ports were accessed
  • For all patients: blood tests to monitor for side effects about once per month

Follow-up included:

  • Monitoring for 90 days to find out if any line infections occurred after lock-therapy stopped

Patients in this study were assigned randomly to receive either ELT or a heparin-saline therapy. The study was ”blinded,” meaning that neither patients nor the staff running the study knew who received which therapy until the study was over.

What did we learn from this study?

Ethanol lock therapy did not prevent infections or keep infections from coming back. In fact, the risk of treatment-failure was the same in each group. While there were no serious adverse events related to the locks, the therapy increased the number of blockages in the lines.  

What are the next research steps as a result of this study?

Even though these results were surprising, the study answered an important research question that will help us treat these infections by reducing the use of an unhelpful treatment. Researchers continue to explore the best ways to prevent central-line infections.

How does this study affect my child?

Every childhood cancer survivor should receive long-term follow-up care. Through the St. Jude After Completion of Care clinic, your child will receive information and guidance for care after treatment. Please speak with your St. Jude doctor about specific guidelines that apply to your child.

For more information

Please talk with your child’s St. Jude doctor about questions or concerns you have as a result of this study.

Publication generated from this study:

Treatment and secondary prophylaxis with ethanol lock therapy for central line-associated bloodstream infection in paediatric cancer: a randomised, double-blind, controlled trial. Wolf J, Connell TG, Allison KJ, Tang L, Richardson J, Branum K, Borello E, Rubnitz JE, Gaur AH, Hakim H, Su Y, Federico SM, Mechinaud F, Hayden RT, Monagle P, Worth LJ, Curtis N, Flynn PM. Lancet Infect Dis. 2018 Aug;18(8):854-863.
https://www.ncbi.nlm.nih.gov/pubmed/29884572