Managing weight in obese patients before heart surgery to see if this improves the effects of surgery

Not Applicable

• Conditions: Pre-operative weight management to improve outcomes of cardiac surgery in adults with obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN16012660
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-06
• Last Update Posted: 26 September 2023
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

1. Adult patients (>17 years) referred for cardiovascular surgery.
2. Patients who have obesity; defined as BMI=30 for patients of White-European ethnicity and as BMI=27.5 for all other ethnic groups.
3. Willingness and ability to commit to up to 12 weekly sessions of the intervention or to commit to weight stability.
4. Behavioural Study 1: Willingness to be interviewed within 24-48 hours of the clinic appointment and have the interview audio recorded.

Exclusion Criteria

1. Patients undergoing urgent or emergency surgery.
2. Patients who are participating in another interventional trial.
3. Patients who are currently/ recently (<3m) enrolled in a weight management programme.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Feasibility outcomes:<br> 1. Number of participants randomised to the intervention arm attending =75% sessions measured using case report forms at 1-day pre-op<br> 2. Number of participants randomised to the control arm whose weight at surgery remains within 1.5kg of their baseline weight (measured as below point 3) at 1-day pre-op<br><br> Efficacy outcome:<br> 3. Weight (kg) baseline and 1-day pre-op measured using weighing scales<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Recruitment rate, attrition rate, data completeness at end of study measured using case report forms<br> 2. A composite endpoint of ischaemic organ injury: low cardiac output, acute kidney, brain or gut injury at day 5 post op measured using clinical observation and blood tests<br> 3. A composite endpoint of infection: surgical site infection, lower respiratory tract infection, urinary tract infection, sepsis at day 5 post op measured using clinical observation and blood tests<br> 4. Adverse events, including mortality, collected from randomisation to 3 months post-surgery at day 5 post op, 6 weeks and 3 months using case report forms<br> 5. Quality of life measured at baseline, 1-day pre-operation and 3 months using the EQ-5D-5L<br> 6. Resource use up to 3 months post-surgery estimated from a bespoke questionnaire at 5 post op, 6 weeks and 3 months<br>