Nutritional Screening in Cardiovascular Disease (NS)

February 12, 2026 updated by: Hull University Teaching Hospitals NHS Trust

Nutritional Screening in Patients With Cardiovascular Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • E. Riding Yorkshire
      • Hull, E. Riding Yorkshire, United Kingdom, HU16 5JQ
        • Recruiting
        • Hull University Teaching Hospitals NHS Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • James P Hobkirk, PhD

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

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing routine NHS cardiac surgery

Description

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

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
Surgical- Group 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in ICU
Time Frame: From ICU admission until ICU discharge, up to 30 days
The total time in hours spent in the ICU, calculated from ICU admission following cardiac surgery to ICU discharge to the general cardiology ward
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
The number of Society of Cardio-thoracic Surgery register of complications
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
Length of hospital stay from admission to medical discharge
From hospital admission until hospital discharge, up to 30 days

Collaborators and Investigators

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

Sponsor

Hull University Teaching Hospitals NHS Trust

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)

August 20, 2025

Primary Completion (Estimated)

December 18, 2026

Study Completion (Estimated)

January 10, 2027

Study Registration Dates

First Submitted

May 21, 2025

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R4162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected anonymised data will be shared if the proposal is deemed to be of sufficient standard.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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