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Recruiting NCT07409519

Nutritional Screening in Cardiovascular Disease

Observational Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nutritional Screening.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Nutritional Screening in Patients With Cardiovascular Disease

Overview

This is a nutritional screening and assessment study conducted prior to heart surgery. The nutritional status of patients will be assessed by a series of questionnaires, blood/urine biomarkers and measurement of grip strength and body composition. The investigators will then evaluate of any of the assessments are linked with clinical outcomes following surgery. For example, how long do patients stop in the intensive care unit (ICU), in hospital and how many complications patients experience. The investigators hope to use this important clinical data to understand how medical staff can identify a poor nutritional status and which patients may need nutritional support prior to surgery.

Detailed description

This is a cross sectional nutritional screening and assessment study conducted prior to cardiac surgery . The investigators will focus on comparing aspects of nutritional status with robust and validated clinical outcomes (mechanical ventilation, ICU time, hospital stay and Society of Cardiothoracic Surgery (SCTS) complications). The investigators will utilise various nutritional screening questionnaires and assessments, including routine clinical malnutrition tools (i.e. MUST, NRS), plus more nutritional quality assessments such as the NOVA ultra-processed food intake, mediterranean diet and blood biomarker panels such as the Prognostic Nutritional Index (PNI), Controlling Nutritional Status (CONUT).

The investigators will also undertake a functional grip strength test and measure body composition including fat mass (FM) \& fat-free mass (FFM), segmental analysis, sarcopenic obesity and visceral fat. The study will also conduct questionnaires regarding other lifestyle related factors (sleep, recent physical activity, stress, anxiety, depression) which might also influence surgical outcomes.

Interventions

  • Behavioral Nutritional Screening
    To identify which nutritional screening approaches (nutritional questionnaires, biomarkers, sarcopenic obesity or grip strength are most strongly linked to surgical outcomes following cardiac surgery.

Primary outcome measures

  • Time in ICU [Time frame: From ICU admission until ICU discharge, up to 30 days]
  • Complications post cardiac surgery [Time frame: Number of complications following cardiac surgery, up to 30 days]
  • Length of Hospital Stay [Time frame: From hospital admission until hospital discharge, up to 30 days]

Eligibility criteria

Inclusion criteria

  • No pre-specified inclusion criteria to ensure we recruit a representative group of patients.

Exclusion criteria

  • All patients without proficiency in English that allows completion of questionnaires
  • Unable to provide written consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United Kingdom · 1 center
  • Hull University Teaching Hospitals NHS Trust — Hull

Identifiers

NCT: NCT07409519 · R4162

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗