SummaryBackgroundThe catheter lock solutions 2% taurolidine and 0.9% saline are both used to prevent catheter‐related bloodstream infections (CRBSIs) in home parenteral nutrition patients.AimsTo compare the effectiveness and safety of taurolidine and saline.MethodsThis multicentre double‐blinded trial randomly assigned home parenteral nutrition patients to use either 2% taurolidine or 0.9% saline for 1 year. Patients were stratified in a new catheter group and a pre‐existing catheter group. Primary outcome was the rate of CRBSIs/1000 catheter days in the new catheter group and pre‐existing catheter group, separately.ResultsWe randomised 105 patients, of which 102 were analysed as modified intention‐to‐treat population. In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04‐0.71; P = 0.009). In the pre‐existing catheter group, rates of CRBSIs/1000 catheter days were 0.39 and 1.32 in the taurolidine and saline arm respectively (relative risk, 0.30; 95% CI, 0.03‐1.82; P = 0.25). Excluding one outlier patient in the taurolidine arm, mean costs per patient were $1865 for taurolidine and $4454 for saline (P = 0.03). Drug‐related adverse events were rare and generally mild.ConclusionsIn the new catheter group, taurolidine showed a clear decrease in CRBSI rate. In the pre‐existing catheter group, no superiority of taurolidine could be demonstrated, most likely due to underpowering. Overall, taurolidine reduced the risk for CRBSIs by more than four times. Given its favourable safety and cost profile, taurolidine locking should be considered as an additional strategy to prevent CRBSIs.
Trial registration: Clinicaltrials.gov, identifier: NCT01826526.
Allogeneic stem cell transplantation (allo-SCT) can induce remission in patients with hematological malignancies due to graft-versus-tumor (GVT) responses. This immune-mediated anti-tumor effect, however, is often accompanied by detrimental graft-versus-host disease (GVHD). Both GVT and GVHD are mediated by minor histocompatibility antigen (MiHA)-specific T cells recognizing peptide products from polymorphic genes that differ between recipient and donor. In this study, we evaluated whether mismatches in a panel of seventeen MiHA are associated with clinical outcome after partial T cell-depleted allo-SCT. Comprehensive statistical analysis revealed that DNA mismatches for one or more autosomal-encoded MiHA was associated with increased relapse-free survival in sibling transplants, (P =0.04), particularly in patients suffering from multiple myeloma (P =0.02). Moreover, mismatches for the ubiquitous Y chromosome-derived MiHA resulted in a higher incidence of acute GVHD (grade 3–4; P =0.004), while autosomal MiHA mismatches, ubiquitous or restricted to hematopoietic cells, were not associated with severe GVHD. Finally, we demonstrated considerable differences between MiHA in their capability to induce in vivo T cell responses using dual-color tetramer analysis of peripheral blood samples collected post-SCT. Importantly, detection of MiHA-specific T cell responses was associated with improved relapse-free survival in sibling transplants (P =0.01). Our findings provide a rationale to further boost GVT immunity towards autosomal MiHA with a hematopoietic restriction to improve outcome after HLA-matched allo-SCT.
Summary
The droplet digital polymerase chain reaction (ddPCR) is a novel molecular technique that allows rapid quantification of rare target DNA sequences. Aim of this study was to explore the feasibility of the ddPCR technique to detect pathogen DNA in whole blood and to assess the diagnostic accuracy of ddPCR to detect bloodstream infections (BSIs), benchmarked against blood cultures. Broad‐range primers and probes were designed to detect bacterial 16S rRNA (and Gram stain for differentiation) and fungal 28S rRNA. To determine the detection limit of ddPCR, 10‐fold serial dilutions of E. coli and C. albicans were spiked in both PBS and whole blood. The diagnostic accuracy of ddPCR was tested in historically collected frozen blood samples from adult patients suspected of a BSI and compared with blood cultures. Analyses were independently performed by two research analysts. Outcomes included sensitivity and specificity of ddPCR. Within 4 h, blood samples were drawn, and DNA was isolated and analysed. The ddPCR detection limit was approximately 1–2 bacteria or fungi per ddPCR reaction. In total, 45 blood samples were collected from patients, of which 15 (33%) presented with positive blood cultures. The overall sensitivity of ddPCR was 80% (95% CI 52–96) and specificity 87% (95% CI 69–96). In conclusion, the ddPCR technique has considerable potential and is able to detect very low amounts of pathogen DNA in whole blood within 4 h. Currently, ddPCR has a reasonable sensitivity and specificity, but requires further optimization to make it more useful for clinical practice.
The StabiliBase adhesive for peristomal attachment of HMEs and/or ASVs was preferred by 76% of study participants and showed a promising prolonged lifespan. This new device further increases the options for stoma attachment in laryngectomized individuals, and subsequently the availability of optimal voice and pulmonary rehabilitation for a larger proportion of patients.
Background
Use of catheter lock solutions (CLSs) as a strategy to prevent catheter‐related bloodstream infections (CRBSIs) has been evaluated in recent clinical trials. Our aim was to identify the most effective CLS formulation in patients receiving home parenteral nutrition (HPN).
Methods
We conducted a systematic review and individual‐patient data meta‐analysis (IPDMA). Prospective randomized clinical trials in adult HPN patients using CLS were identified from PubMed, EMBASE, Web of Science, CINAHL, Cochrane library, and ClinicalTrials.gov. Primary outcome was the number of CRBSIs per 1000 catheter days for each CLS. Other outcomes included time to CRBSI and identification of patients with a higher risk for CRBSIs.
Results
In total, 1107 studies were screened for eligibility, of which three studies comprising 162 HPN patients and 45,695 catheter days were included in the IPDMA. CRBSI rates were significantly decreased in patients using taurolidine (rate 0.13; 95% confidence interval [CI], 0.05–0.32) when compared with saline (rate 0.74; 95% CI, 0.31–1.74; P = .002) or heparin (rate 2.01; 95% CI, 1.03–3.91; P < .001). The cumulative proportion of CRBSI‐free patients using taurolidine, saline, and heparin after 1 year was 88%, 56%, and 14%, respectively. Three risk factors for CRBSIs were identified: type of CLS, intestinal dysmotility as underlying condition, and use of central venous catheters.
Conclusions
Taurolidine was the most effective CLS formulation in HPN patients for the prevention of CRBSIs. We suggest discussing with patients the benefits and risks when starting taurolidine, especially in patients who are considered to have a higher risk for CRBSIs.
Longer lifetime of the adhesive baseplate in patients with smaller volume outcomes suggests that a more accurate fit between baseplate and stoma leads to better fixation. This should be taken into account when shaping a stoma during laryngectomy. On the other hand, a more custom-made patch that has a more accurate fit could increase the lifetime of fixation. We believe that our three-dimensional volumetric data can contribute to the development of such an adhesive.
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