Continuous enteral nutrition compared with a maximal gastric vacuity strategy at the time of extubation in the intensive care unit: protocol for a non-inferiority cluster randomised trial (the Ambroisie Project)

IntroductionFasting is frequently imposed to patients before extubation in the intensive care unit based on scheduled surgery guidelines. This practice has never been evaluated among critically ill patients and may delay extubation, increase nursing workload and reduce caloric intake. We are hypothesising that continuous enteral nutrition until extubation represents a safe alternative compared with fasting prior to extubation in the intensive care unit.Methods and analysisAdult patients ventilated more than 48 hours and receiving pre-pyloric enteral nutrition for more than 24 hours are included in this open-label cluster randomised parallel group non-inferiority trial. The participating centres are randomised allocated to continued enteral nutrition until extubation or 6-hour fasting (with concomitant gastric suctioning when feasible) prior to extubation. The primary outcome is extubation failure (ie, reintubation within 7 days following extubation).Ethics and disseminationThis study has been approved by the national ethics review board (comité de protection, des personnes Sud Mediterranée III No 2017.10.02 bis) and patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals.Trial registration numberClinicalTrials.gov Registry (NCT03335345).

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Impact of Propofol Sedation upon Caloric Overfeeding and Protein Inadequacy in Critically Ill Patients Receiving Nutrition Support

Pharmacy ◽

10.3390/pharmacy9030121 ◽

2021 ◽

Vol 9 (3) ◽

pp. 121

Author(s):

Roland N. Dickerson ◽

Christopher T. Buckley

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Enteral Nutrition ◽

Parenteral Nutrition ◽

Critically Ill Patients ◽

Protein Intake ◽

Lipid Emulsion ◽

Caloric Intake ◽

Nutrition Therapy ◽

Nutrition Support

Propofol, a commonly used sedative in the intensive care unit, is formulated in a 10% lipid emulsion that contributes 1.1 kcals per mL. As a result, propofol can significantly contribute to caloric intake and can potentially result in complications of overfeeding for patients who receive concurrent enteral or parenteral nutrition therapy. In order to avoid potential overfeeding, some clinicians have empirically decreased the infusion rate of the nutrition therapy, which also may have detrimental effects since protein intake may be inadequate. The purpose of this review is to examine the current literature regarding these issues and provide some practical suggestions on how to restrict caloric intake to avoid overfeeding and simultaneously enhance protein intake for patients who receive either parenteral or enteral nutrition for those patients receiving concurrent propofol therapy.

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A Cluster Randomised Trial of a Multifaceted Quality Improvement Intervention in Brazilian Intensive Care Units

Intensive Care Medicine Experimental ◽

10.1186/2197-425x-3-s1-a24 ◽

2015 ◽

Vol 3 (S1) ◽

Author(s):

AB Cavalcanti ◽

◽

FA Bozza ◽

FR Machado ◽

JIF Salluh ◽

...

Keyword(s):

Intensive Care ◽

Quality Improvement ◽

Intensive Care Units ◽

Randomised Trial ◽

Quality Improvement Intervention ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Improvement Intervention

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Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial

BMJ Open ◽

10.1136/bmjopen-2020-040110 ◽

2020 ◽

Vol 10 (11) ◽

pp. e040110

Author(s):

Mikaela Smit ◽

Annalisa Marinosci ◽

Giovanni Jacopo Nicoletti ◽

Thomas Perneger ◽

Silvio Ragozzino ◽

...

Keyword(s):

Randomised Trial ◽

Standard Of Care ◽

Cluster Randomised Trial ◽

Postexposure Prophylaxis ◽

Open Label ◽

Daily Monitoring ◽

Intention To Treat ◽

Cluster Randomised ◽

Registration Number ◽

Asymptomatic Individuals

IntroductionLopinavir/ritonavir (LPV/r) has been proposed as repurposed drugs for pre-exposure and postexposure prophylaxis as well as therapy of COVID-19. Coronavirus postexposure prophylaxis (COPEP) trial aims at assessing their efficacy as postexposure ring-prophylaxis among adults exposed to SARS-CoV-2.Methods and analysisCOPEP is a two-arm open-label cluster-randomised trial conducted in three cantons of Switzerland. Asymptomatic contacts (≥16 years) of individuals diagnosed with COVID-19 will be randomised (2:1) to either LPV/r (400 mg/100 mg two times per day) for 5 days, or a standard of care arm (no treatment). Asymptomatic individuals may be either SARS-CoV-2 positive or negative. Contacts living in the single household will form a cluster and will be randomised into the same arm. All participants will be followed-up for 21 days and undergo daily monitoring for COVID-19 symptoms. The primary endpoint is 21-day incidence of laboratory-confirmed COVID-19 with ≥1 compatible symptom, analysed in an intention-to-treat (ITT) analysis. The secondary endpoints include the 21-day incidence of COVID-19 as well as SARS-CoV-2 infection in a modified ITT analysis, excluding participants who had a positive SARS-CoV-2 RT-PCR from oropharyngeal swab and/or a positive SARS-CoV-2 IgG serology at baseline. Assuming a 21-day incidence for COVID-19 of 20% among contacts without postexposure chemoprophylaxis, to detect a relative risk reduction of 60% (ie, translating in an absolute reduction from 20% to 8%), with a power of 80%, an alpha of 5%. Accounting for design effect of cluster design of circa 1.1, we plan to enrol 200 participants to the LPV/r arm and 100 to the standard of care arm, 300 participants in total.Ethics and disseminationEthics approval has been granted by the Commission Cantonale d’Ethique de la Recherche, Ethikkommission Nordwest- und Zentralschweiz and Comitato Etico Cantonale (ref 2020-00864) and Swissmedic (2020DR3056). Results from this trial will be disseminated via journal articles and presentations at national and international conferences.Trial registration numberClinicaltrials.gov Registry (NCT04364022); Swiss National Clinical Trial Portal Registry (SNCTP 000003732).Registered report identifierCCER 2020-0864.

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