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Randomized Controlled Trial
. 2023 Jun 3;12(1):55.
doi: 10.1186/s13756-023-01260-w.

Central-line associated bloodstream infections in intensive care units before and after implementation of daily antiseptic bathing with chlorhexidine or octenidine: a post-hoc analysis of a cluster-randomised controlled trial

Luisa A Denkel  1   2 , Frank Schwab  3   4 , Jörg Clausmeyer  3   4 , Michael Behnke  3   4 , Jennifer Golembus  3   4 , Solvy Wolke  3   4 , Petra Gastmeier  3   4 , Christine Geffers  3   4 ; CLIP-ID study group
Affiliations
Randomized Controlled Trial

Central-line associated bloodstream infections in intensive care units before and after implementation of daily antiseptic bathing with chlorhexidine or octenidine: a post-hoc analysis of a cluster-randomised controlled trial

Luisa A Denkel et al. Antimicrob Resist Infect Control. .

Abstract

Backgrounds: Antiseptic bathing did not reduce central-line (CL) associated bloodstream infection (CLABSI) rates in intensive care units (ICU) according to a recent cluster randomised controlled trial (cRCT). However, this analysis did not consider baseline infection rates. Our post-hoc analysis of this cRCT aimed to use a before-after comparison to examine the effect of daily bathing with chlorhexidine, octenidine or water and soap (control) on ICU-attributable CLABSI rates.

Methods: A post-hoc analysis of a multi-center cRCT was done. ICUs that did not yet perform routine antiseptic bathing were randomly assigned to one of three study groups applying daily bathing with 2% chlorhexidine-impregnated cloths, 0.08% octenidine wash mitts or water and soap (control) for 12 months. Baseline data was assessed 12 months before the intervention started when all ICUs routinely used water and soap. Poisson regression and generalised estimating equation models were applied to identify changes of CLABSI rates per 1000 CL days between intervention and baseline periods in each study group.

Results: The cRCT was conducted in 72 ICUs (24 per study group) including 76,139 patients in the baseline and 76,815 patients in the intervention period. In the chlorhexidine group, incidence density of CLABSI was reduced from 1.48 to 0.90 CLABSI per 1000 CL days comparing baseline versus intervention period (P = 0.0085). No reduction was observed in the octenidine group (1.26 versus 1.47 CLABSI per 1000 CL days, P = 0.8735) and the control group (1.20 versus 1.17, P = 0.3298). Adjusted incidence rate ratios (intervention versus baseline) were 0.63 (95%CI 0.46-0.87, P = 0.0172) in the chlorhexidine, 1.17 (95% CI 0.79-1.72, P = 0.5111) in the octenidine and 0.98 (95% CI 0.60-1.58, P = 0.9190) in the control group. Chlorhexidine bathing reduced CLABSI with gram-positive bacteria, mainly coagulase-negative staphylococci (CoNS).

Conclusions: In this post-hoc analysis of a cRCT, the application of 2% chlorhexidine-impregnated cloths reduced ICU-attributable CLABSI. This preventive effect of chlorhexidine was restricted to CLABSI caused by gram-positive pathogens (CoNS). In contrast, 0.08% octenidine wash mitts did not reduce CLABSI rates in ICUs. Trial registration Registration number DRKS00010475, registration date August 18, 2016.

Keywords: Antiseptic bathing; CLABSI; Chlorhexidine gluconate; Octenidine dihydrochloride; Post-hoc before-after analysis.

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Conflict of interest statement

All authors have no conflicts of interest to declare. On behalf of all authors, the corresponding author states that there is no conflict of interest. The German Ministry of Education and Research (funder) and companies (Sage Products/Stryker, Schülke) funding products and the investigation of tolerances of bacterial isolates to chlorhexidine and octenidine by an independent laboratory had no role in study design, data collection and analysis, data interpretation, the decision to publish, or the preparation of the manuscript.

Figures

Fig. 1
Fig. 1
CLIP-ID trial design of the post-hoc before-after analysis
Fig. 2
Fig. 2
Incidence densities of CLABSI per 1000 CL days with any pathogen (A) and gram-positive bacteria (B) per study group in baseline and intervention period. Chlorhexidine (CHG, wide dashed line in blue), octenidine (OCT, small dashed line in red) and control group (routine care = water and soap, solid line in green). Months 1–12 represent the baseline, months 13–24 the intervention period. The latter have been shown elsewhere [15]. CLABSI, central line associated bloodstream infections. CL central line, PM pooled mean
Fig. 3
Fig. 3
Effect of trial interventions on CLABSI with any pathogen for all ICUs (A), for ICUs < 0.8 CLABSI per 1000 CL-days at baseline (B) and ICUs with ≥ 0.8 CLABSI per 1000 CL-days (C) visualised by study group. Logarithmised incidence rate ratios (ln(IRR)) are depicted for CLABSI with any pathogen. Results are based on unadjusted Poisson regression models (IRR) for single ICUs and adjusted GEE models (aIRR) for study groups (first bubble per group) with 95% confidence intervals (indicated by vertical lines). P values were given for type III test. The sizes of bubbles represent the number of CL days from the individual ICU relative to their group effect. For wards that did not observe any case of CLABSI in the baseline or intervention period the IRR was set to 10 (ln(10) = 2.3) and 0.1 (ln(1/10) =  − 2.3), respectively. For the logarithmised incidence rate ratios, equal distances to ZERO (= no effect) in positive or negative directions have the same effect sizes in opposite directions. aIRR adjusted incidence rate ratio, CL central line (central venous catheter), ICU intensive care unit, IRR incidence rate ratio
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