Double-Blind Prospective Randomized Study Comparing Topical Mupirocin and Placebo for the Prevention of Infection Associated with Central Venous Catheters

OBJECTIVE: To compare the incidence of exit site colonization, local catheter-related infection and catheter-related bacteremia in patients randomized to receive either topical 2% mupirocin or placebo at the catheter exit site.PATIENTS AND METHODS: Patients requiring central venous catheters for more than three days were randomized to receive in a double-blind fashion either topical mupirocin or an identical placebo at the exit site three times weekly at the time of dressing change. Insertion, site care and removal of catheters were standardized. Serial semiquantitataive cultures of the skin at the catheter insertion site were performed using a sterile 25 cm2template. The distal and proximal catheter segments were cultured using a standardized semiquantitative technique, and any suspect catheter-related bacteremia was investigated with two sets of peripheral blood cultures, a 10 mL sample of infusate and clinical assessment. Both univariate and multivariate analyses were conducted on individual risk factors to determine factors that might influence the outcomes of local or systemic catheter-related infection.RESULTS: Local catheter-related infection (defined as more than 15 colony forming units [cfu] on culture of the proximal or distal catheter segment) occurred in six of 57 (10.5%) in the mupirocin group versus 18 of 69 (26%) in the placebo group (P<0.05) for the distal catheter segments and in one of 40 (2.5%) versus 13 of 47 (27.6%) for the proximal segments in the mupirocin and placebo groups (P<0.006), respectively. Catheter-related bacteremia occurred in one of 57 (1.8%) of the mupirocin group but in five of 69 (7.2%) of the placebo group (P=0.15). Stepwise logistic regression revealed that cutaneous colonization at the insertion site of at least 103cfu/mL/25 cm2(OR 2.6; CI 1.0 to 6.9) and the use of placebo (OR 3.3; CI 1.2 to 9.0) were significant factors predicting local catheter-related infection; whereas mupirocin was associated with reciprocal protective effect (OR 0.3; 95% CI 0.1 to 0.8).CONCLUSIONS: These findings suggest that patients receiving topical mupirocin at the exit site for long term central venous catheters have significantly less local catheter-related infection, and there is a trend towards less catheter-related bacteremia.

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Taurolock versus saline 5% on preventing infection and dysfunction of hemodialysis catheters; a randomized, double blind controlled clinical trial

Journal of Renal Injury Prevention ◽

10.34172/jrip.2021.25 ◽

2020 ◽

Vol 10 (3) ◽

pp. e25-e25

Author(s):

Ali Ghorbani ◽

Fatemeh Hayati ◽

Mehrdad Dargahi-MalAmir ◽

Maryam Afkane

Keyword(s):

Central Venous Catheters ◽

Controlled Clinical Trial ◽

Organic Solution ◽

Central Venous ◽

Double Blind ◽

Catheter Related Infection ◽

Prevention Of Thrombosis ◽

Catheter Dysfunction ◽

Significant Difference ◽

Prevention Of Infections

Introduction: Despite the higher rate of morbidity and mortality, the use of central venous catheters has increased significantly compared to arteriovenous fistula. So far, no ideal organic solution has been identified for the prevention of thrombosis and catheter-related infection in patients undergoing hemodialysis. Objectives: This study aimed to evaluate the efficacy of Taurolock versus saline 5% on the prevention of catheter dysfunction and catheter-related infections. Patients and Methods: Seventy patients with chronic kidney disease, who requiring hemodialysis or those with permanent hemodialysis catheters referring to hemodialysis centers of Ahvaz, were selected and randomly divided into two groups, while 68 patients remained until the end of the study. In the first group, saline 5% was inserted into the lumen of catheter after each hemodialysis, and then catheter was blocked. In the second group, Taurolock solution (TauroLock™ -Hep 500®: Taurolidine; antimicrobial agent), citrate 4% and heparin (UI/mL) were used as antibiotics. Results: No significant difference between the catheter-related infection and positive blood culture in both saline and Taurolock groups was detected (2.94% versus 2.94%; P >0.05). Moreover, the catheter-related dysfunction in the saline 5% group was 5% less than the Taurolock group (2.94% versus 11.76%, P = 0.365). Conclusion: The results showed that saline 5% is at least as effective as a Taurolock solution for prevention of infections and catheter dysfunction. Saline is an effective, inexpensive, safe and readily available in various settings. Therefore, it could be considered as a proper alternative solution for reduction of dialysis-related side effects and costs. Trial Registration: Registration of trial protocol has been approved in Iranian registry of controlled trials (identifier: IRCT20190304042918N1; https://en.irct.ir/trial/38055, ethical code# IR.AJUMS.REC.1397.412).

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Prevention of bacteremia attributed to luminal colonization of tunneled central venous catheters with vancomycin-susceptible organisms.

Journal of Clinical Oncology ◽

10.1200/jco.1990.8.9.1591 ◽

1990 ◽

Vol 8 (9) ◽

pp. 1591-1597 ◽

Cited By ~ 139

Author(s):

C Schwartz ◽

K J Henrickson ◽

K Roghmann ◽

K Powell

Keyword(s):

Fungal Infections ◽

Central Venous Catheters ◽

First Episode ◽

Exit Site ◽

Central Venous ◽

Suspected Sepsis ◽

Hematologic Disorders ◽

Kaplan Meier ◽

Vancomycin Resistant ◽

To Receive

Forty-five children with oncologic or hematologic disorders requiring tunneled central venous catheters (TCVC) for the administration of immunosuppressive therapy were randomized to receive either 10 U/mL heparin (H) (24 patients) or a solution of 10 U/mL H and 25 micrograms/mL vancomycin (H-V) (21 patients) for all catheter flushes. Episodes of fever or suspected sepsis were evaluated to determine whether the addition of vancomycin to the flush solution would alter the incidence of symptomatic bacteremia attributed to luminal colonization of TCVC with vancomycin-susceptible bacteria. Patients were enrolled for 247 +/- 150 days, accounting for a total of 11,095 days of catheter use. Bacteremia attributed to luminal colonization with vancomycin-susceptible organisms occurred in five patients (six infections) receiving H alone compared with zero patients receiving H-V (P = .035). The time to the first episode of bacteremia with vancomycin-susceptible organisms, analyzed by Kaplan-Meier survival curves, was significantly longer in patients receiving H-V (P = .04). There were no differences in the incidence of other infections including bacteremia attributed to luminal colonization with vancomycin-resistant organisms, other bacteremias (including those arising from the catheter exit site), exit-site cellulitis, or fungal infections. No organisms resistant to vancomycin were identified. Vancomycin could not be detected in the peripheral blood of patients receiving vancomycin in the flush solution. No vancomycin-related toxicities were noted. We conclude that the use of an H-V flush solution in immunocompromised patients with TCVC can decrease the frequency of bacteremia attributed to luminal colonization with vancomycin-susceptible bacteria.

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Reduction in catheter-related infections after switching from povidone-iodine to chlorhexidine for the exit-site care of tunneled central venous catheters in children on hemodialysis

Hemodialysis International ◽

10.1111/hdi.12218 ◽

2014 ◽

Vol 18 ◽

pp. S13-S18 ◽

Cited By ~ 14

Author(s):

Fabio Paglialonga ◽

Silvia Consolo ◽

Antonietta Biasuzzi ◽

Jolanda Assomou ◽

Elisabetta Gattarello ◽

...

Keyword(s):

Povidone Iodine ◽

Central Venous Catheters ◽

Exit Site ◽

Central Venous

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Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

10.1101/2021.04.13.21255409 ◽

2021 ◽

Author(s):

Juan Manuel Figueroa ◽

Monica Lombardo ◽

Ariel Dogliotti ◽

Luis Flynn ◽

Robert P. Giugliano ◽

...

Keyword(s):

Placebo Group ◽

Nasal Spray ◽

Controlled Trial ◽

Hospital Personnel ◽

Culture Methods ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Efficacy ◽

To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

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Pirenzepine in Non-Ulcer Dyspepsia: A Double-Blind Multicentre Trial

Journal of International Medical Research ◽

10.1177/030006059001800103 ◽

1990 ◽

Vol 18 (1) ◽

pp. 16-20 ◽

Cited By ~ 7

Author(s):

P.M. Smith ◽

A.H. Troughton ◽

F. Gleeson ◽

J. Walters ◽

C.F. McCarthy

Keyword(s):

Abdominal Pain ◽

Placebo Group ◽

Adverse Effects ◽

Multicentre Study ◽

Multicentre Trial ◽

Nausea And Vomiting ◽

Double Blind ◽

Non Ulcer Dyspepsia ◽

Upper Abdominal ◽

To Receive

In a double-blind multicentre study to compare pirenzepine with placebo in non-ulcer dyspepsia, 71 patients were randomized to receive 50 mg pirenzepine or placebo given orally twice daily for 4 weeks. The trial was not completed by five patients in the pirenzepine group and six in the placebo group. There were no significant differences between the groups in respect to changes in total symptoms (upper abdominal pain, nausea and vomiting, early satiety and postprandial bloating, eructation and pyrosis) scores and outcome, although 27/35 (77%) patients receiving pirenzepine were cured or improved compared with 22/36 (61%) receiving the placebo. Adverse effects were reported by 13 (37%) patients treated with pirenzepine and by six (17%) treated with placebo, seven withdrawing due to adverse effects.

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Practices and Predictors of Analgesic Interventions for Adults Undergoing Painful Procedures

American Journal of Critical Care ◽

10.4037/ajcc2002.11.5.415 ◽

2002 ◽

Vol 11 (5) ◽

pp. 415-429 ◽

Cited By ~ 68

Author(s):

Kathleen A. Puntillo ◽

Lorie Rietman Wild ◽

Ann Bonham Morris ◽

Julie Stanik-Hutt ◽

Carol Lynn Thompson ◽

...

Keyword(s):

Combination Therapy ◽

Pain Intensity ◽

Regression Models ◽

Central Venous Catheters ◽

Central Venous ◽

Factors Associated ◽

Anesthetic Agents ◽

Multiple Regression Models ◽

Tracheal Suctioning ◽

To Receive

• Background Research is limited on analgesic practices associated with the commonly performed procedures of turning, inserting central venous catheters, removing wound drains, changing dressings on nonburn wounds, suctioning the trachea, and removing femoral sheaths. • Objective To determine types of analgesics administered for procedures, the prevalence and amounts of drugs given, and factors predictive of analgesic administration. • Methods Pain was assessed before and immediately after procedures. Analgesic, sedative, and anesthetic agents administered within 1 hour before and/or during each procedure were noted. • Results A total of 5957 adult patients at 164 national and 5 international sites participated. Pain intensity increased at the time of procedure for all procedures. More than 63% of patients received no analgesics. Less than 20% received opiates; mean total dose of opiate was 6.44 mg (SD, 8.96 mg). Only 10% of patients received combination therapy. Factors associated with the likelihood of receiving opiates were pain intensity before a procedure, femoral sheath removal, being white, and the duration of a procedure. Patients less likely to receive opiates had a medical diagnosis or were having tracheal suctioning. Only 14.5% of the variance in the amount of opiate administered was explained by factors entered into multiple regression models. Type of procedure was the only significant predictor of amount of opiate administered. • Conclusions Most patients were not intentionally medicated even though pain intensity increased during their procedure. When used, analgesic amounts were low, and combination therapy was infrequent. Clinical trials are needed to evaluate optimal pain management for patients undergoing procedures.

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Effect of a Fermented Milk CombiningLactobacillus AcidophilusCL1285 andLactobacillus Caseiin the Prevention of Antibiotic-Associated Diarrhea: A Randomized, Double-Blind, Placebo-Controlled Trial

Canadian Journal of Gastroenterology ◽

10.1155/2007/720205 ◽

2007 ◽

Vol 21 (11) ◽

pp. 732-736 ◽

Cited By ~ 98

Author(s):

Mélanie Beausoleil ◽

Nadia Fortier ◽

Stéphanie Guénette ◽

Amélie L’Ecuyer ◽

Michel Savoie ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Randomized Study ◽

Fermented Milk ◽

Daily Basis ◽

Hospitalized Patients ◽

Double Blind ◽

Antibiotic Associated Diarrhea ◽

Potential Measure ◽

To Receive

BACKGROUND: Antibiotic-associated diarrhea is an important problem in hospitalized patients. The use of probiotics is gaining interest in the scientific community as a potential measure to prevent this complication. The main objective of the present study was to assess the efficacy and safety of a fermented milk combiningLactobacillus acidophilusandLactobacillus caseithat is widely available in Canada, in the prevention of antibiotic-associated diarrhea.METHODS: In this double-blind, randomized study, hospitalized patients were randomly assigned to receive either a lactobacilli-fermented milk or a placebo on a daily basis.RESULTS: Among 89 randomized patients, antibiotic-associated diarrhea occurred in seven of 44 patients (15.9%) in the lactobacilli group and in 16 of 45 patients (35.6%) in the placebo group (OR 0.34, 95% CI 0.125 to 0.944; P=0.05). The median hospitalization duration was eight days in the lactobacilli group, compared with 10 days in the placebo group (P=0.09). Overall, the lactobacilli-fermented milk was well tolerated.CONCLUSION: The daily administration of a lactobacilli-fermented milk was safe and effective in the prevention of antibiotic-associated diarrhea in hospitalized patients.

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Peripherally Inserted Central Catheters Are a Good Option For Venous Access In The Patients With Hematologic Diseases

Blood ◽

10.1182/blood.v122.21.2956.2956 ◽

2013 ◽

Vol 122 (21) ◽

pp. 2956-2956 ◽

Cited By ~ 1

Author(s):

Naoko Takaiwa ◽

Masanori Seki ◽

Naoki Kurita ◽

Yasuhisa Yokoyama ◽

Mamiko Sakata-Yanagimoto ◽

...

Keyword(s):

Risk Factors ◽

Cell Transplantation ◽

Hematopoietic Cell Transplantation ◽

Conflicts Of Interest ◽

Insertion Site ◽

Infectious Complications ◽

Central Venous Catheters ◽

Hematopoietic Cell ◽

Central Venous ◽

Hematologic Diseases

Abstract Background Central venous catheters are widely used for treatments of hematologic diseases. Conventional central venous catheters (CVC), however, often cause complications such as pneumothorax, hematoma, catheter-related blood stream infection (CR-BSI), and so on. Peripherally inserted central venous Catheters (PICC) are recently expected to reduce these complications. The aim of this study was to compare the frequencies of and risk factors for complications with PICC and CVC in patients with hematologic diseases. Patients and Methods We retrospectively reviewed all 363 patients who had inserted PICC or CVC for treatment of hematologic diseases in January 2011 through July 2013 at the University of Tsukuba Hospital. Overall and device-specific frequencies of infectious and non-infectious complications were evaluated and potential risk factors were captured. Results The PICC group (N = 215) and CVC group (N = 148) were similar in terms of clinical backgrounds, types of complications during catheter insertion, and total time of catheter-inserted periods. The CVC group had significantly higher proportions of patients who received hematopoietic cell transplantation (PICC 17.7% vs. CVC 49.3%, P<0.001). The significant intergroup differences were found in frequencies of CR-BSI (PICC, 1.4/1000 catheter days and CVC, 5.9/1000 catheter days; P<0.001) and local infection at the insertion site (PICC, 0.3/1000 catheter days and CVC, 2.3/1000 catheter days; P=0.002). The cumulative incidence of catheter removal for infective infectious complications was higher in the CVC group than the PICC group (PICC 8.7% vs. CVC 37.3%, P<0.001). Multivariate analysis showed that PICC significantly reduced the incidence of CR-BSI (odds ratio (OR), 0.15; 95% confidence interval (CI), 0.06-0.33; P<0.001). The incidence of CR-BSI was also significant higher in patients who received hematopoietic cell transplantation (OR, 2.4; 95%CI, 1.22-4.69; P=0.01). Phlebitis and deep vein thrombosis was noted in no patient in PICC group and 1 patient in CVC group. Conclusion Our date suggest that PICC is superior to CVC in terms of infectious complications. Low incidence of thrombophlebitis, observed in this study, is a key to a major change of practice from CVC to PICC. Disclosures: No relevant conflicts of interest to declare.

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Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.9007 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 9007-9007 ◽

Cited By ~ 4

Author(s):

S. Lee ◽

Y. Chun ◽

M. Kim ◽

H. Chang ◽

...

Keyword(s):

Placebo Group ◽

Chemotherapy Regimen ◽

Controlled Study ◽

Double Blind Study ◽

Double Blind ◽

Significant Difference ◽

Hand Foot Syndrome ◽

Version 2.0 ◽

The Mean ◽

To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

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