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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04136119
Other study ID # IRAS 268780
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 18, 2019
Est. completion date December 1, 2020

Study information

Verified date October 2019
Source Guy's and St Thomas' NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Nutritional support is an important component of modern critical care. The practice of vitamin and micronutrient supplementation is variable and official guidelines are not consistent. The primary objective of this observational study is to investigate the clinical practice of micronutrient supplementation during critical illness and to explore the factors underpinning clinical decisions.


Description:

Nutritional support is an integral component of modern critical care. Malnutrition is common, but measurement of serum concentrations of most vitamins and micronutrients does not form part of routine care for most critically ill adults in the UK. When measured in a research setting, a large proportion of critically ill patients have low serum concentrations of many essential nutrients. Nutrient deficiency is associated with adverse outcomes, including delirium and increased mortality. To date, it is unclear whether there is a role for micronutrient supplementation in critically ill patients. Official guidelines from the European Society of Parenteral and Enteral Nutrition (ESPEN), American Society of Parenteral and Enteral Nutrition (ASPEN), German Intensive Care Society and Kidney Disease Improving Global Outcome (KDIGO) vary and are contradictory to some extent. Additionally, vitamins B1 and C have been administered as an intervention in the treatment of septic shock and other disease states, but methodological flaws with such studies have left many clinicians with equipoise over the place of vitamin and micronutrients in clinical practice. There is a need for a well designed, adequately powered intervention study. In preparation, we would like to explore current practice and decision making of doctors, pharmacists and dieticians who are directly involved in prescribing nutritional support. The primary objective of this observational study is to investigate the clinical practice of micronutrient supplementation during critical illness and to explore the factors underpinning clinical decisions.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - healthcare professional who is involved in prescribing vitamins or micronutrients to critically ill patients in the ICU Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
survey exploring practice of vitamin and micronutrient supplementation

Locations

Country Name City State
United Kingdom Guy's & St Thomas Foundation Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinical practice of vitamin supplementation indications for vitamin supplementation October 2019 - April 2020
Primary clinical practice of micronutrient supplementation indications for micronutrient supplementation October 2019 - April 2020
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