The Safety and Efficacy of Propofol Containing EDTA: A Randomised Clinical Trial Programme Focusing on Cation and Trace Metal Homeostasis in Critically Ill Patients

Vasodilatory shock is common in critically ill patients and vasopressors are a mainstay of therapy. A meta-analysis suggested that use of a higher, as opposed to a lower, mean arterial pressure target to guide titration of vasopressor therapy, could be associated with a higher risk of death in older critically ill patients. The 65 trial is a pragmatic, multi-centre, parallel-group, open-label, randomised clinical trial of permissive hypotension (a mean arterial pressure target of 60 -65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vasodilatory hypotension. The trial is conducted in 2600 patients from 65 United Kingdom adult, general critical care units. The primary outcome is all-cause mortality at 90 days. An economic evaluation is embedded. The 65 trial received favourable ethical opinion from the South Central - Oxford C Research Ethics Committee and approval from the Health Research Authority. The results will be presented at national and international conferences and published in peer-reviewed medical journals. Trial registration: ISRCTN10580502

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Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension: Protocol for the 65 randomised clinical trial

Journal of the Intensive Care Society ◽

10.1177/1751143719870088 ◽

2019 ◽

pp. 175114371987008 ◽

Cited By ~ 1

Author(s):

Alvin Richards-Belle ◽

Paul R Mouncey ◽

Richard D Grieve ◽

David A Harrison ◽

M Zia Sadique ◽

...

Keyword(s):

Clinical Trial ◽

Mean Arterial Pressure ◽

Arterial Pressure ◽

Critically Ill ◽

Critically Ill Patients ◽

Randomised Clinical Trial ◽

Vasopressor Therapy ◽

Permissive Hypotension ◽

Risk Of Death ◽

South Central

Vasodilatory shock is common in critically ill patients and vasopressors are a mainstay of therapy. A meta-analysis suggested that use of a higher, as opposed to a lower, mean arterial pressure target to guide titration of vasopressor therapy, could be associated with a higher risk of death in older critically ill patients. The 65 trial is a pragmatic, multi-centre, parallel-group, open-label, randomised clinical trial of permissive hypotension (a mean arterial pressure target of 60–65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vasodilatory hypotension. The trial is conducted in 2600 patients from 65 United Kingdom adult, general critical care units. The primary outcome is all-cause mortality at 90 days. An economic evaluation is embedded. The 65 trial received favourable ethical opinion from the South Central – Oxford C Research Ethics Committee and approval from the Health Research Authority. The results will be presented at national and international conferences and published in peer-reviewed medical journals. Trial registration: ISRCTN10580502

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The Importance of the Microbiome in Critically Ill Patients: Role of Nutrition

Nutrients ◽

10.3390/nu11123002 ◽

2019 ◽

Vol 11 (12) ◽

pp. 3002 ◽

Cited By ~ 2

Author(s):

Rocio Moron ◽

Julio Galvez ◽

Manuel Colmenero ◽

Per Anderson ◽

José Cabeza ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Practice ◽

Critically Ill ◽

Critically Ill Patients ◽

Fecal Microbiota Transplantation ◽

Fecal Microbiota ◽

Safety And Efficacy ◽

Beneficial Effects ◽

Nutritional Strategies

Critically ill patients have an alteration in the microbiome in which it becomes a disease-promoting pathobiome. It is characterized by lower bacterial diversity, loss of commensal phyla, like Firmicutes and Bacteroidetes, and a domination of pathogens belonging to the Proteobacteria phylum. Although these alterations are multicausal, many of the treatments administered to these patients, like antibiotics, play a significant role. Critically ill patients also have a hyperpermeable gut barrier and dysregulation of the inflammatory response that favor the development of the pathobiome, translocation of pathogens, and facilitate the emergence of sepsis. In order to restore the homeostasis of the microbiome, several nutritional strategies have been evaluated with the aim to improve the management of critically ill patients. Importantly, enteral nutrition has proven to be more efficient in promoting the homeostasis of the gut microbiome compared to parenteral nutrition. Several nutritional therapies, including prebiotics, probiotics, synbiotics, and fecal microbiota transplantation, are currently being used, showing variable results, possibly due to the unevenness of clinical trial conditions and the fact that the beneficial effects of probiotics are specific to particular species or even strains. Thus, it is of great importance to better understand the mechanisms by which nutrition and supplement therapies can heal the microbiome in critically ill patients in order to finally implement them in clinical practice with optimal safety and efficacy.

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