Micronutrients in Critically Ill Patients (MiNuCrit)

A Survey of Practice of Micronutrient Supplementation in Critically Ill Patients

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, SE1 7EH
        • Guy's & St Thomas Foundation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

health care professionals working in the ICU

Description

Inclusion Criteria:

  • healthcare professional who is involved in prescribing vitamins or micronutrients to critically ill patients in the ICU

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthcare professionals
doctors, pharmacists and dieticians who are involved in prescribing vitamins and micronutrients to critically ill patients
survey exploring practice of vitamin and micronutrient supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical practice of vitamin supplementation
Time Frame: October 2019 - April 2020
indications for vitamin supplementation
October 2019 - April 2020
clinical practice of micronutrient supplementation
Time Frame: October 2019 - April 2020
indications for micronutrient supplementation
October 2019 - April 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 18, 2019

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (ACTUAL)

October 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IRAS 268780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

individual participant data will not be made available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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