Ethanol lock therapy ineffective at preventing, treating CLABSIs

SAN DIEGO — No benefits have been observed from the use of ethanol lock therapy as a treatment or prophylaxis for central line-associated bloodstream infections in children with hematologic and oncologic disorders, according to a recent presentation held at IDWeek 2017.

The researchers note that this practice may increase the likelihood of the child experiencing adverse events, including catheter occlusion.

“Central venous catheters are ubiquitous in modern cancer therapy, especially modern pediatric cancer therapy, and are essential. Unfortunately, catheters are also associated with a number of complications,” Joshua Wolf, MBBS, FRACP, from the department of infectious diseases at St. Jude Children’s Hospital, Memphis, Tenn., said during a presentation.

Ethanol lock therapy did not prevent treatment failure from central line-associated bloodstream infections in the pediatric population, and increased the risk of occlusion and overall adverse events, according to research presented at ID Week 2017.

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“The most common serious complication is central line-associated bloodstream infections, which have been attributed to luminal biofilm or complex communities of microorganisms on the inside surface of the catheter,” Wolfe continued. “One proposed mechanism to address this problem is with ethanol lock therapy, with the belief that this could help remove the luminal biofilm, either when given as treatment during an infection or as prophylaxis to prevent the build-up of biofilm on the inside surface of the device.”

To examine whether ethanol lock therapy demonstrates efficacy in preventing treatment failure caused by persistent infection, infection relapse or new infection, the researchers conducted a prospective, dual-center, double-blind, block-randomized, placebo-controlled trial in which they used 70% ethanol in water to treat central line-associated bloodstream infections (CLABSIs) in children for 2 hours per lumen per day over the course of 24 weeks. Ethanol was also administered as a prophylaxis for 2 hours per lumen up to 3 days per week throughout the study.

Intervention and control groups were analyzed and compared for risk factors associated with treatment failure according to proportional and cumulative incidence models. To assist the researchers in this process, Wolf and colleagues used intention-to-treat and cumulative incidence analyses. All children included were diagnosed with hematologic or oncologic disorders (NCT01472965).

Of the 94 children included in the study, 48 received ethanol lock therapy and 46 received a placebo, with both groups demonstrating similar baseline variables. Treatment failure was observed in 43.6% of those who received ethanol lock therapy (11 early failure, nine relapse, 21 reinfection), and the risk of treatment failure was comparable in children who received a placebo (43.8% vs. 43.5%, P = .09). Additionally, no differences were observed in the two groups regarding cumulative incidence of treatment failure in intention-to-treat as well as per-protocol analyses.

“The treatment failure rate was identical — down to the decimal point — to the expected rate in our control group,” Wolf said during the presentation. “Failure was not different between the ethanol lock therapy or placebo groups.”

Although no significant differences were observed between the two groups concerning the likelihood of liver function test elevations (14.6% vs. 26.1%), infusion reactions (18.8% vs. 8.7%) or other adverse events, children who received ethanol were at a significantly higher risk of experiencing catheter occlusion (58.3% vs. 32.6%, P = .01).

“We found that ethanol lock therapy, given as a treatment or secondary prophylaxis, did not prevent treatment failure from CLABSIs, including early failure or recurrence of infection, and increased the risk of occlusion and overall adverse events,” Wolfe said. “We do not think ethanol lock therapy should be recommended in this population, but there may be a role for primary prophylaxis in some patients.”–by Katherine Bortz

Reference:

Wolf J, et al. LB-6. Ethanol treatment and secondary prophylaxis for central line-associated bloodstream infection in pediatric hematology and oncology: A randomized, double-blind, placebo-controlled, intervention trial. Presented at: IDWeek 2017; Oct. 4-8; San Diego.

Disclosure: The authors report no relevant financial disclosures.