Nutritional screening and intervention in patients with CVD

• Research type

  Research Study

• Full title

  Nutritional screening and intervention in patients undergoing treatment for cardiovascular disease.

• IRAS ID

  270562

• Contact name

  Mahmoud Loubani

• Contact email

  mahmoud.loubani@nhs.net

• Sponsor organisation

  The University of Hull Teaching Hospitals Trust

• Duration of Study in the UK

  1 years, 11 months, 28 days

• Research summary

  Nutrition is an important lifestyle behaviour and highly amenable to change. This study is being conducted to nutritionally screen and intervene in patients who require heart surgery.

  Nutritional screening:

  Malnourishment is a strong predictor of poor outcome. Malnourishment is usually identified in patients with a low BMI or has recent unintended weight loss. However, many patients are overweight/obese. These patients are rarely referred to a dietitian as they are assumed to be well nourished.
  We want to conduct nutritional screening in all patients and assess how nutritional status links with surgical outcomes. We want to compare clinically utilised nutritional screening tools (MUST etc) with

  2) Body composition and grip strength
  3) Objectively assessed nutritionally related clinical blood biomarkers

  We want to identifying poor nutritional status and the strongest predictor(s) of surgical outcomes which may be adopted in clinical practice.

  To complement our screening protocol, we wish to apply for REC approval to utilise stored blood samples from the Outcome Monitoring in Cardiac Surgery study(IRAS number 137511].
  We would like to investigate the prevalence of malnutrition using clinical blood biomarkers.

  We will also be seeking patient and health care professionals views on lifestyle prehabilitation and its delivery in cardiac surgery via a questionnaire. This is a key part of our BHF grant in cardiac surgery prehabilitation.

  Nutritional intervention:

  The nutritional RCT will be conducted in patients who are overweight/obese and have evidence of inflammation (hs-CRP of >3mg/L). The intervention is an randomised placebo controlled trial. Patients will be randomly assigned to a microbiome modulator OR placebo for 6 weeks prior to their planned surgery. We will assess the effects of the nutritional intervention with the changes to standard and non-standard blood variables, faecal biomarkers of microbial abundance and diversity. We will assess the following clinical primary outcomes (in hospital mortality, mechanical ventilation, ICU stay (hours), and post-operative complications.

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  23/NW/0309

• Date of REC Opinion

  25 Jan 2024

• REC opinion

  Further Information Favourable Opinion