scholarly journals Economic evaluation alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (E-PROSPECT): study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036047
Author(s):  
Vincent Issac Lau ◽  
Deborah J Cook ◽  
Robert Fowler ◽  
Bram Rochwerg ◽  
Jennie Johnstone ◽  
...  
Keyword(s):  
Incremental Cost ◽  
Usual Care ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Severe Pneumonia ◽  
Sensitivity Analyses ◽  
Public Healthcare ◽  
Surgical Trauma ◽  
Unit Costs ◽  
Individual Site

IntroductionVentilator-associated pneumonia (VAP) is a common healthcare-associated infection in the intensive care unit (ICU). Probiotics are defined as live microorganisms that may confer health benefits when ingested. Prior randomised trials suggest that probiotics may prevent infections such as VAP and Clostridioides difficile–associated diarrhoea (CDAD). PROSPECT (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial) is a multicentre, double-blinded, randomised controlled trial comparing the efficacy of the probiotic Lactobacillus rhamnosus GG with usual care versus usual care without probiotics in preventing VAP and other clinically important outcomes in critically ill patients admitted to the ICU.Methods and analysisThe objective of E-PROSPECT is to determine the incremental cost-effectiveness of L. rhamnosus GG plus usual care versus usual care without probiotics in critically ill patients. E-PROSPECT will be performed from the public healthcare payer’s perspective over a time horizon from ICU admission to hospital discharge.We will determine probabilities of in-ICU and in-hospital events from all patients alongside PROSPECT. We will retrieve unit costs for each resource use item using jurisdiction-specific public databases, supplemented by individual site unit costs if such databases are unavailable. Direct costs will include medications, personnel costs, radiology/laboratory testing, operative/non-operative procedures and per-day hospital ‘hoteling’ costs not otherwise encompassed. The primary outcome is the incremental cost per VAP prevented between the two treatment groups. Other clinical events such as CDAD, antibiotic-associated diarrhoea and in-hospital mortality will be included as secondary outcomes. We will perform pre-specified subgroup analyses (medical/surgical/trauma; age; frailty status; antibiotic use; prevalent vs no prevalent pneumonia) and probabilistic sensitivity analyses for VAP, then generate confidence intervals using the non-parametric bootstrapping approach.Ethics and disseminationStudy approval for E-PROSPECT was granted by the Hamilton Integrated Research Ethics Board of McMaster University on 29 July 2019. Informed consent was obtained from the patient or substitute decision-maker in PROSPECT. The findings of this study will be published in peer-reviewed journals.Trial registration numberNCT01782755; Pre-results.

scholarly journals Cost effectiveness of dressing in the prevention of catheter-related infection in critically ill patients

2018 ◽  
Vol 12 (10) ◽  
pp. 871-877
Author(s):  
Edivane Pedrolo ◽  
Mitzy Tannia Reichembach Danski ◽  
Astrid Wiens ◽  
Radamés Boostel
Keyword(s):  
Cost Effectiveness ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Venous Catheter ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Public Healthcare ◽  
Catheter Related Infection ◽  
Probability Of Death ◽  
The Cost

Introduction: Catheter-related infection is a complication of high morbimortality. The aim was to perform a cost-effectiveness analysis of gauze and medical tape, transparent semi–permeable and chlorhexidine-impregnated dressings for short-term central venous catheter, within the Brazilian Public Healthcare System (Sistema Único de Saúde – SUS) scenario. Methodology: a decision tree was elaborated in order to evaluate the cost-effectiveness of dressings in the prevention of catheter-related infection in critically ill patients. The outcome was the probability of catheter-related infections prevention. Moreover, only direct medical expenses were considered. Sensitivity analyses were performed to evaluate the model uncertainties. Results: Chlorhexidine-impregnated dressing presented higher cost-effectiveness when the base case was analyzed (cost of US$ 655 per case prevented, 99% of effectiveness), in comparison to gauze and medical tape dressing (US$ 696, effectiveness of 96%). Dressing changes performed before the recommended period, treatment performed exclusively in inpatient units and high effectiveness of gauze and medical tape dressing were variables that interfered with the results. The probability of death has also demonstrated to have a major impact on cost-effectiveness. Conclusion: In the context of a Brazilian public hospital, the chlorhexidine-impregnated dressing presented higher cost-effectiveness when compared to the gauze and medical tape dressing or the transparent semi-permeable dressing.

scholarly journals Higher Incidence of Stroke in Severe COVID-19 Is Not Associated With a Higher Burden of Arrhythmias: Comparison With Other Types of Severe Pneumonia

2021 ◽  
Vol 8 ◽  
Author(s):  
Peter Jirak ◽  
Zornitsa Shomanova ◽  
Robert Larbig ◽  
Daniel Dankl ◽  
Nino Frank ◽  
...  
Keyword(s):  
Risk Factors ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Severe Pneumonia ◽  
Thromboembolic Events ◽  
Therapeutic Anticoagulation ◽  
Tertiary Hospitals ◽  
Ventricular Tachycardias ◽  
Disease Specific ◽  
Rhythm Monitoring

Aims: Thromboembolic events, including stroke, are typical complications of COVID-19. Whether arrhythmias, frequently described in severe COVID-19, are disease-specific and thus promote strokes is unclear. We investigated the occurrence of arrhythmias and stroke during rhythm monitoring in critically ill patients with COVID-19, compared with severe pneumonia of other origins.Methods and Results: This retrospective study included 120 critically ill patients requiring mechanical ventilation in three European tertiary hospitals, including n =60 COVID-19, matched according to risk factors for the occurrence of arrhythmias in n = 60 patients from a retrospective consecutive cohort of severe pneumonia of other origins. Arrhythmias, mainly atrial fibrillation (AF), were frequent in COVID-19. However, when compared with non-COVID-19, no difference was observed with respect to ventricular tachycardias (VT) and relevant bradyarrhythmias (VT 10.0 vs. 8.4 %, p = ns and asystole 5.0 vs. 3.3%, p = ns) with consequent similar rates of cardiopulmonary resuscitation (6.7 vs. 10.0%, p = ns). AF was even more common in non-COVID-19 (AF 18.3 vs. 43.3%, p = 0.003; newly onset AF 10.0 vs. 30.0%, p = 0.006), which resulted in a higher need for electrical cardioversion (6.7 vs. 20.0%, p = 0.029). Despite these findings and comparable rates of therapeutic anticoagulation (TAC), the incidence of stroke was higher in COVID-19 (6.7.% vs. 0.0, p = 0.042). These events also happened in the absence of AF (50%) and with TAC (50%).Conclusions: Arrhythmias were common in severe COVID-19, consisting mainly of AF, yet less frequent than in matched pneumonia of other origins. A contrasting higher incidence of stroke independent of arrhythmias also observed with TAC, seems to be an arrhythmia-unrelated disease-specific feature of COVID-19.

Application of Network Meta-Analysis to Assess the Comparative Effectiveness of Oral Care Interventions in Preventing Ventilator Associated Pneumonia in Critically Ill Patients.

2020 ◽  
Author(s):  
Satheeshkumar PS ◽  
Stephen Sonis
Keyword(s):  
Usual Care ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Povidone Iodine ◽  
Meta Analysis ◽  
Oral Care ◽  
Forest Plot ◽  
Care Groups ◽  
Ranking Order ◽  
Hierarchical Assessment

Abstract Background In this research, we assessed the efficacy of a novel analytic, network metanalysis (NMA), in creating a hierarchy to define the most effective oral care intervention (OCI) for the prevention and management of ventilation-associated pneumonia (VAP). Methods We applied NMA to a previously published robust pairwise meta-analysis (PMA). Statistical analyses were based on comparing rates of total VAP events between intervention groups and placebo-usual care groups. We synthesized a netgraph, reported ranking order of the treatment and summarized our output by a forest plot with a reference treatment placebo/usual care. Results With our inclusion and exclusion critiera for the NMA we extracted 25 studies (4473 subjects). The NMA included 16 treatments, 29 pairwise comparisons and 15 designs. Based on the results of multiple comparisons with frequentist ranking probability P scores, tooth brushing (P score fixed of 0.9353, P score random of 0.8892), toothbrushing with povidone iodine (P score fixed of 0.9091, P score random 0.8801), and furacillin (P score fixed of 0.8798, P score random 0.8358) were the best three interventions for preventing VAP. Conclusion NMA appeared to be an effective platform from which multiple interventions reported in disparate clinical trials could be compared to derive a hierarchical assessment of efficacy in the intervention of VAP. According to the NMA outcome, toothbrushing alone or toothbrushing along with a potent antiseptic mouthwash povidone iodine was related to the highest response rate in preventing VAP in critically ill patients followed by furacillin and chlorhexidine 0.2%, respectively.

Hydrocortisone vs Tocilizumab Effects on Cytokine Storm in Critically Ill Patients with COVID-19.

2020 ◽  
Author(s):  
Maria Vargas ◽  
Pasquale Buonanno ◽  
Carmine Iacovazzo ◽  
Gaetano Di Spigna ◽  
Daniela Spalletti ◽  
...  
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Statistical Significance ◽  
Plasma Concentrations ◽  
Severe Pneumonia ◽  
Cytokine Storm ◽  
Tnf Α ◽  
Speed Up ◽  
The Impact ◽  
Late Stages

Abstract Introduction: Patients with severe pneumonia due COVID-19 are reported to have substantially lower lymphocyte counts and higher plasma concentrations of a number of inflammatory cytokines. In the late stages of COVID-19, cytokine storms are the mainly cause of disease progression and death. We performed a prospective observational study to evaluate the impact of tocilizumab and hydrocortisone on cytokine storm in critically ill patients with COVID-19.Methods: We included all adult patients with laboratory-confirmed COVID-19 infection and severe respiratory failure admitted to our ICU from March 10 to April 30. As therapeutic options, patients received tocilizumab od hydrocortisone. The primary end point was the evaluation of cytokine storm in terms of variation of the IL-6 and IL-6R, sgp130 and TNF-α concentrations during time to different treatment.Results: Eight patients received tocilizumab while 15 patients received hydrocortisone. IL-6 levels were lower in the hydrocortisone group with statistical significance was found at the days 2, 3, 8 and 9. The levels of IL-6R were lower during the days in the hydrocortisone group with statistical significance at days 1, 2, 3, 4, 5, 6, 8 and 10. Hydrocortisone group had higher levels of TNF-α at days 2, 3 and 4. The levels of sgo130 between tocilizumab and hydrocortisone groups were not statistically different during the days.Conclusions: In critically ill patients with severe COVID-19, the use of hydrocortisone allowed a better control of the cytokine storms, was further associated to less days of curarization, pronation and length of stay in ICU, and speed up the time to get negative RT-PCR swab.

scholarly journals Evaluating probiotics for the prevention of ventilator-associated pneumonia: a randomised placebo-controlled multicentre trial protocol and statistical analysis plan for PROSPECT

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025228 ◽  
Author(s):  
Jennie Johnstone ◽  
Diane Heels-Ansdell ◽  
Lehana Thabane ◽  
Maureen Meade ◽  
John Marshall ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Hospital Length Of Stay ◽  
Sensitivity Analyses ◽  
Ventilator Associated Pneumonia ◽  
Increased Risk ◽  
The Impact

IntroductionVentilator-associated pneumonia (VAP) is the most common healthcare-associated infection in critically ill patients. Prior studies suggest that probiotics may reduce VAP and other infections in critically ill patients; however, most previous randomised trials were small, single centre studies. The Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) aims to determine the impact of the probioticLactobacillus rhamnosusGG on VAP and other clinically important outcomes in critically ill adults.MethodsPROSPECT is a multicentre, concealed, randomised, stratified, blinded, controlled trial in patients ≥18 years old, anticipated to be mechanically ventilated ≥72 hours, in intensive care units (ICUs) in Canada, the USA and Saudi Arabia. Patients receive either 1×1010 colony forming units ofL. rhamnosusGG twice daily or an identical appearing placebo. Those at increased risk of probiotic infection are excluded. The primary outcome is VAP. Secondary outcomes are other ICU-acquired infections includingClostridioides difficileinfection, diarrhoea (including antibiotic-associated diarrhoea), antimicrobial use, ICU and hospital length of stay and mortality. The planned sample size of 2650 patients is based on an estimated 15% VAP rate and will provide 80% power to detect a 25% relative risk reduction.Ethics and disseminationThis protocol and statistical analysis plan outlines the methodology, primary and secondary analyses, sensitivity analyses and subgroup analyses. PROSPECT is approved by Health Canada (#9427-M1133-45C), the research ethics boards of all participating hospitals and Public Health Ontario. Results will be disseminated via academic channels (peer reviewed journal publications, professional healthcare fora including international conferences) and conventional and social media. The results of PROSPECT will inform practice guidelines worldwide.Trialregistration numberNCT02462590; Pre-results.

scholarly journals A Prospective Determination of the Incidence of Perceived Inappropriate Care in Critically Ill Patients

2014 ◽  
Vol 21 (3) ◽  
pp. 165-170 ◽  
Author(s):  
Rohit K Singal ◽  
Robert Sibbald ◽  
Brenda Morgan ◽  
Mel Quinlan ◽  
Neil Parry ◽  
...  
Keyword(s):  
Health Care ◽  
End Of Life ◽  
Critically Ill ◽  
Health Care Providers ◽  
Critically Ill Patients ◽  
Public Awareness ◽  
Surgical Trauma ◽  
Care Providers ◽  
Inappropriate Care ◽  
End Of Life Issues

BACKGROUND: Health care providers’ perceptions regarding appropriateness in end-of-life treatments have been widely studied. While nurses and physicians believe that rationing and other cost-related practices sometimes occur in the intensive care unit (ICU), they allege that treatment is often excessive.OBJECTIVE: To prospectively determine the incidence and causes of health care providers’ perceptions regarding appropriateness of end-of-life treatments.METHODS: The present prospective study collected data from patients admitted to the medical-surgical trauma ICU of a 30-bed, Canadian teaching hospital over a three-month period. Daily surveys were completed independently by bedside nurses, charge nurses and attending physician.RESULTS: In total, 5224 of 6558 expected surveys (representing 294 patients) were analyzed, yielding a response rate of 79.7%. The incidence of perceived inappropriate care in the present study was 6.5% (19 of 294 patients), with ongoing treatment for >2 days after this determination occurring in 1% (three of 294 patients). However, at least one caregiver perceived inappropriate care at some point in 110 of 294 (37.5%) patients. In these cases, in which processes to address care were not already underway, respondents believed that important issues resulting in provision of inappropriate treatments included patient-family issues and communication before or in the ICU. Caregivers did not know their patients’ wishes 22% (1129 of 5224) of the time.CONCLUSIONS: Although ongoing inappropriate care appeared to be a rare occurrence, the issue was a concern to at least one caregiver in one-third of cases. Public awareness for end-of-life issues, adequate communication, and up-to-date knowledge and practice in determining the wishes of critically ill patients are potential target areas to improve end-of-life care and reduce inappropriate care in the ICU. A daily, prospective survey of multidisciplinary caregivers, such as the survey used in the present study, is a viable and valuable means of determining the scope and causes of inappropriate care in the ICU.

scholarly journals Pulmonary Embolism in Patients with COVID-19

2022 ◽  
Vol 5 (1) ◽  
pp. 01-06
Author(s):  
Scarduelli Cleante ◽  
Scarduelli Sara ◽  
Borghi Claudio
Keyword(s):  
Pulmonary Embolism ◽  
Usual Care ◽  
Hospital Discharge ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Therapeutic Dose ◽  
High Rate ◽  
Organ Support ◽  
Probability Of Survival ◽  
Prophylactic Anticoagulation

Infection with the novel severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the resulting syndrome, COVID-19, have been associated with inflammation and a prothrombotic state, with increases in fibrin, fibrinogen, fibrin degradation products and D-dimers. In some studies, elevations in these markers have been associated with worse clinical outcomes. Several studies have demonstrated a high prevalence of venous thromboembolism (VTE), and pulmonary embolism (PE), particularly in patients admitted to the intensive care unit (ICU), even in those receiving prophylactic anticoagulation. The high rate of thrombosis in COVID-19 is driven by at least two interrelated processes: a hypercoagulable state responsible for large-vessel thrombosis and thromboembolism and direct vascular and endothelial injury responsible for in situ microvascular thrombosis. The presence of PE and pulmonary thrombosis may explain why hypoxemia is out of proportion to impairment in lung compliance in some patients with COVID-19 pneumonia. Diagnosing PE in patients with COVID-19 pneumonia may be challenging, because the two pathologies share many signs and symptoms. It has been demonstrated that the administration of prophylactic anticoagulation within 24 h of admission in patients with COVID-19 was associated with decreased mortality when compared with no prophylactic anticoagulation. Given the antithrombotic, anti-inflammatory and possibly antiviral properties of heparins, it has been hypothesized that anticoagulation with heparin administered at doses higher than conventionally used for venous thromboprophylaxis may improve outcomes. In non-critically ill patients hospitalized with COVID-19, therapeutic-dose anticoagulants with heparin (most commonly, low-molecular-weight heparin) increased the probability of survival until hospital discharge with a reduced need for ICU-level organ support at 21 days as compared with usual-care thromboprophylaxis. In Critically ill patients with confirmed COVID-19, therapeutic-dose anticoagulation did not increase the probability of survival to hospital discharge or the number of days free of cardiovascular o respiratory organ support and had a 95% probability of being inferior to usual-care pharmacologic thromboprophylaxis. Currently, randomized trials evaluating the use of tissue plasminogen activator and Tenecteplase in patients with COVID-19 ARDS are underway.

scholarly journals Outcome of Critically ill Patients Undergoing Mandatory Insulin Therapy Compared to Usual Care Insulin Therapy: Protocol for a Pilot Randomized Controlled Trial� (Preprint)

2016 ◽  
Author(s):  
Peter J Watkinson ◽  
Vicki S Barber ◽  
J Duncan Young
Keyword(s):  
Randomized Controlled Trial ◽  
Intensive Care ◽  
Insulin Therapy ◽  
Usual Care ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Blood Glucose Control ◽  
Complication Rates ◽  
Randomized Controlled

BACKGROUND Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advantage or reduces complication rates. Policies of “tight” glycaemic control were rapidly adopted by many general intensive care units (ICUs) worldwide in the mid 00’s, even though the results of the studies were not generalizable to mixed medical/surgical ICUs with different intravenous feeding policies. OBJECTIVE The primary objective of the study is to assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting. METHODS This protocol summarizes the rationale and design of a randomized, controlled, single-center trial investigating the effect of mandatory insulin therapy versus usual care insulin therapy for those patients admitted for a stay of longer than 48 hours. In total, 109 critically ill adults predicted to stay in intensive care for longer than 48 hours consented. The primary outcome is to determine the safety of mandatory insulin therapy in critically ill patients using the number of episodes of hypoglycaemia and hypokalaemia per unit length of stay in intensive care. Secondary outcomes include the duration of mechanical ventilation, duration of ICU and hospital stay, hospital mortality, and measures of renal, hepatic, and haematological dysfunction. RESULTS The project was funded in 2005 and enrolment was completed 2007. Data analysis is currently underway and the first results are expected to be submitted for publication in 2018. CONCLUSIONS This protocol for a randomized controlled trial investigating the effect of mandatory insulin therapy should provide an answer to a key question for the management of patients in the ICU and ultimately improving outcome. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN00550641; http://www.isrctn.com/ISRCTN00550641 (Archived at WebCite: http://www.webcitation.org/6xk8NXxNv).

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