NCT07409519

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Aug 2025Jan 2027

First Submitted

Initial submission to the registry

May 21, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2026

Expected
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2027

Last Updated

February 13, 2026

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

May 21, 2025

Last Update Submit

February 12, 2026

Conditions

Keywords

NutritionScreeningCardiac surgeryClincial outcomes

Outcome Measures

Primary Outcomes (3)

  • Time in ICU

    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

    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

    Length of hospital stay from admission to medical discharge

    From hospital admission until hospital discharge, up to 30 days

Study Arms (1)

Surgical- Group 1

Behavioral: Nutritional Screening

Interventions

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

Surgical- Group 1

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing routine NHS cardiac surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hull University Teaching Hospitals NHS Trust

Hull, E. Riding Yorkshire, HU16 5JQ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum and Urine

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Mahmoud M Loubani, MD

CONTACT

James P Hobkirk, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2025

First Posted

February 13, 2026

Study Start

August 20, 2025

Primary Completion (Estimated)

December 18, 2026

Study Completion (Estimated)

January 10, 2027

Last Updated

February 13, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations