A multicentre analysis of catheter-related infection based on a hierarchical model

Purpose

To decrease intensive care unit (ICU)-acquired catheter-related infections (CRI), it is essential that healthcare workers receive training and that quality improvement programmes are in place. The aim of our study was to evaluate risk factors for catheter colonisation and infection, focussing specifically on local care bundles.

Methods

Data were collected prospectively in 51 ICUs [7,188 patients, 8,626 central venous catheters (CVCs)] during two 6-month periods in 2007 and 2008, using a standardized questionnaire on catheter insertion, care and removal. Colonisation and CRI incidence were 6.1 and 2.2/1,000 CVC-days, respectively. A hierarchical mixed logistic model was used to identify risk factors for CRI and colonisation.

Results

Written CVC protocols were available in 46 (90?%) ICUs and were strictly followed in 38 ICUs. Factors significantly associated with CRI fell into three overall categories: (1) patient-related factors—immunosuppression [odds ratio (OR) 1.42, p?=?0.02], medical diagnosis at admission (OR 1.64, p?=?0.03) and trauma patient (OR 2.54, p?p?p?p??4); (3) centre-related factors—quantitative tip culture method (OR 2.55, p?=?0.005) and alcohol-based povidone-iodine [OR 0.68, 95?% confidence interval (CI) 0.49–0.96] or alcohol-based chlorhexidine preparations (OR 0.69, 95?% CI 0.34–1.39) as compared to an aqueous povidone-iodine preparation (p?Conclusions We identified several risk factors for CRI that are amenable to improvement (preference for the subclavian route and use of an antiseptic solution containing alcohol). However, several patient-related factors were also found, and the use of quantitative catheter culture methods increased culture sensitivity, thereby increasing the CRI rate. Case-mix issues and the culture method should be taken into account when assessing the risk of CRI across centres.     

Nanostructured porous silicon microparticles enable sustained peptide (Melanotan II) delivery

Peptide molecules can improve the treatment of a number of pathological conditions, but due to their physicochemical properties, their delivery is very challenging. The study aim was to determine whether nanostructured porous silicon could sustain the release and prolong the duration of action of a model peptide Melanotan II (MTII). Thermally hydrocarbonized nanoporous silicon (THCPSi) microparticles (38-53 μm) were loaded with MTII. The pore diameter, volume, specific surface area and loading degree of the microparticles were analyzed, and the peptide release was evaluated in vitro. The effects of MTII on heart rate and water consumption were investigated in vivo after subcutaneous administration of the MTII loaded microparticles. A peptide loading degree of 15% w/w was obtained. In vitro studies (PBS, pH 7.4, 37 °C) indicated sustained release of MTII from the THCPSi microparticles. In vivo, MTII loaded THCPSi induced an increase in the heart rate 2 h later than MTII solution, and the effect lasted 1 h longer. In addition, MTII loaded THCPSi changed the water consumption after 150 min, when the immediate effect of MTII solution was already diminished. The present study demonstrates that MTII loading into nanosized PSi pore structure enables sustained delivery of an active peptide.     

Physicochemical stability of high indomethacin payload ordered mesoporous silica MCM-41 and SBA-15 microparticles

Stability of high indomethacin (IMC) content formulations based on ordered mesoporous silica MCM-41 and SBA-15 materials was studied before and after a 3 month storage in stressed conditions (30 °C/56% RH). Overall, the physical stability of the samples was found satisfactory after the storage. However, some issues with the chemical stability were noted, especially with the MCM-41 based samples. The stability issues were evident from the decreased HPLC loading degrees of the drug after stressing as well as from the observed extra peaks in the HPLC chromatograms of the drug in the stressed samples. Drug release from the mesoporous formulations before stressing was rapid at pH 1.2 in comparison to bulk crystalline IMC. The release profiles also remained similar after stressing. Even faster and close to complete IMC release was achieved when the pH was raised from 1.2 to 6.8. To our knowledge, this is the first report of chemical stability issues of drugs in mesoporous silica drug formulations. The present results encourage further study of the factors affecting the chemical stability of drugs in mesoporous silica MCM-41 and SBA-15 formulations in order to realize their potential in oral drug delivery.     

A comparison of home measurement and ambulatory monitoring of blood pressure in the adjustment of antihypertensive treatment

BACKGROUND: The purpose of this study was to compare home and ambulatory blood pressure (BP) in the adjustment of antihypertensive treatment. METHODS: After a 4-week washout period, patients whose untreated daytime diastolic ambulatory BP averaged > or = 85 mm Hg were randomized to be treated according to their ambulatory or home BP. Antihypertensive treatment was adjusted at 6-week intervals according to the mean daytime ambulatory diastolic BP or the mean home diastolic BP, depending on the patient's randomization group. If the diastolic BP stayed above 80 mm Hg, the physician blinded to randomization intensified hypertensive treatment. RESULTS: Ninety-eight patients completed the study. During the 24-week follow-up period both systolic and diastolic BP decreased significantly within both groups (P < .001). At the end of the study, the systolic/diastolic differences between ambulatory (n = 46) and home (n = 52) BP groups in home, daytime ambulatory, night-time ambulatory, and 24-h ambulatory BP changes averaged 2.6/2.6 mm Hg, 0.6/1.7 mm Hg, 1.0/1.4 mm Hg, and 0.6/1.5 mm Hg, respectively (P range .06 to .75) A nonsignificant trend to more intensive drug therapy in the ambulatory BP group and a nonsignificant trend to larger share of patients reaching (57.7% v 43.5%, P = .16) the target pressure in the home BP group was observed due to the 3.8 mm Hg difference in ambulatory and home diastolic BP at randomization. CONCLUSIONS: The adjustment of antihypertensive treatment based on either ambulatory or home BP measurement led to good BP control. No significant between-group differences in BP changes were seen at the end of the study. Additional research is needed to provide more conclusive results.     

Robot-assisted versus three-dimensional laparoscopic radical prostatectomy: 12-month outcomes of a randomised controlled trial

Objectives

To compare functional and oncological outcomes of robot-assisted laparoscopic prostatectomy (RALP) to three-dimensional laparoscopic radical prostatectomy (3D-LRP) at 12 months after surgery.

Patients and methods

Prospective randomised single-centre study of 145 consecutive men referred to radical prostatectomy in a tertiary referral centre in Finland. Patients were randomised 1:1 to the RALP (N = 75) and 3D-LRP (N = 70) groups. The primary outcome was urinary continence evaluated with the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26) incontinence domain score at 12 months after surgery. Secondary outcomes included the use of protective pads at 12 months after surgery, EPIC-26 domain scores of irritative/obstructive, bowel, sexual and hormonal symptoms, positive surgical margin (PSM) rate, and biochemical recurrence (BCR). Complication frequency within the 3-month period after surgery was evaluated according to Clavien–Dindo classification. Statistical significance between groups was analysed using Mann–Whitney, chi-square and Fisher's exact tests. The trial was terminated after interim analysis based on no statistically significant difference in EPIC-26 urinary incontinence domain scores. Altogether 145 patients of the target accrual of 280 patients were recruited.

Results

Postoperative continence at 12 months after surgery according to the EPIC-26 incontinence domain was 79.25 in both groups (P = 0.4). Between group difference was −5.8 (95% confidence interval –15.2 to 3.6). There was no statistically significant difference in the rates of PSM or BCR between the two surgical modality groups.

Conclusion

We were unable to demonstrate a difference between the RALP and 3D-LRP groups for functional and oncological outcomes at 12 months after surgery.     

The artificial bowel sphincter for faecal incontinence: a single centre study

Background and aims Faecal incontinence (FI) is a socially devastating problem. The treatment algorithm depends on the aetiology of the problem. Large anal sphincter defects can be treated by sphincter replacement procedures: the dynamic graciloplasty and the artificial bowel sphincter (ABS). Materials and methods Patients were included between 1997 and 2006. A full preoperative workup was mandatory for all patients. During the follow-up, the Williams incontinence score was used to classify the symptoms, and anal manometry was performed. Results Thirty-four patients (25 women) were included, of which, 33 patients received an ABS. The mean follow-up was 17.4 (0.8–106.3) months. The Williams score improved significantly after placement of the ABS (p < 0.0001). The postoperative anal resting pressure with an empty cuff was not altered (p = 0.89). The postoperative ABS pressure was significantly higher then the baseline squeeze pressure (p = 0.003). Seven patients had an infection necessitating explantation. One patient was successfully reimplanted. Conclusion The artificial bowel sphincter is an effective treatment for FI in patients with a large anal sphincter defect. Infectious complications are the largest threat necessitating explantation of the device.     

Assessment of sedation level for endoscopic retrograde cholangiopancreatography – a prospective validation study

Background and aims: There is no consensus on how to assess the depth of sedation for endoscopic retrograde cholangiopancreatography (ERCP). This study was carried out in order to evaluate different methods of assessment of depth of sedation: bispectral index (BiS), modified Richmond Agitation/Sedation Scale (mRASS), modified Ramsay Sedation Scale (mRSS) and modified Observer Assessment of Alertness and Sedation (mOAAS) and their applicability to clinical practice.

Methods: Two hundred patients were recruited. Sedation was given by standard clinical practice using propofol sedation or patient controlled sedation. Sedation was assessed on all patients using the above-mentioned methods. BiS was considered the reference point for sedation scales. Cronbach’s alpha was calculated to determine the consistency of different scales in respect to each other and prediction probability and Spearman’s correlation coefficients of sedation scales were calculated to show the relationship between sedation scales and BiS.

Results: All scales showed high reliability with overall Cronbach’s alpha 0.943. Dropping scales suggested better consistency between mOAAS, mRSS and mRASS than with BiS. Spearman’s correlation and prediction probability showed similar results with all tested scales: mOAAS (0.695, 0.739), mRSS (0.673, 0.735), mRASS (0.683, 0.738), p?Conclusions: All tested methods were found to be reliable in the assessment of the depth of sedation when compared with each other. However, mRASS, mRSS and mOAAS require the patient to respond to verbal or tactile stimulus, which may impair execution of ERCP, whereas BiS information is collected directly from electroencephalogram and thus may be preferable in clinical setting.