The PRE-OP ENERGY Trial

NCT04015973 | Unknown

• 3 other identifiers: 066824600918/EM/0254
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The PRE-OP ENERGY Trial proposes to test the overarching hypothesis that a pre-surgery high energy diet will protect patients against organ damage during cardiac surgery with cardiopulmonary bypass.

Conditions

Cardiac Valve Disease; Coronary Artery Disease; Organ Failure, Multiple

Outcome Measures

Primary Outcomes (2)

• Change of Serum Creatinine level

  Measurement of Serum Creatinine level and expressed as umol/L.

  Baseline, 0-6, 6-12, 24, 48, 72, and up to 96 hours post-operatively

• Change of Serum Troponin I level

  Measurement of Serum Troponin level and expressed as ng/L.

  Baseline, 0-6, 6-12, 24, 48 and 72 hours post-operatively

Secondary Outcomes (41)

• Post-surgery organ injury: Sepsis-related Organ Failure

  Baseline, pre-operatively, 0-6, 6-12, 24, 48, 72 and 96 hours post-operatively

• Post-surgery organ injury: Kidney Injury (Urinary Biomarkers) - NGAL (Neutrophil gelatinase associated lipocalcin)

  Baseline, 1 day pre-op, 6-12, 24 and 48 hours post-operatively

• Post-surgery organ injury: Kidney Injury (Urinary Biomarkers) - microRNA (Neutrophil gelatinase associated lipocalcin)

  Baseline, 1 day pre-op, 6-12, 24 and 48 hours post-operatively

• Post-surgery organ injury: Kidney Injury

  Daily for 5 days from Baseline

• Post-surgery organ injury: Kidney Injury

  At 6 weeks and then 3 months post-surgery

Other Outcomes (15)

• Body Composition: Bone Density Scan (DEXA)

  Baseline, pre-assessment and 3 months post-surgery

• Imaging Assessment of Cardiometabolic Status: Trans-Oesophageal Echo

  At time of surgery

• Imaging Assessment (optional): Cardiac Magnetic Resonance Imaging - Cardiac Function

  Baseline, pre-assessment and 3 months post-surgery

Study Arms (2)

Group A: Control

NO INTERVENTION

Standard Care

Group B: High energy diet

EXPERIMENTAL

High energy diet for 8-12 weeks pre-surgery

Dietary Supplement: High energy diet

Interventions

High energy diet DIETARY_SUPPLEMENT

An overfeeding regime of 135% required energy intake per day, set from baseline energy requirements consisting of high (saturated) fat snacks, added to the usual diet, supervised by a dietitian.

Group B: High energy diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ALL of the following:
• Adult cardiac surgery patients (≥18 years) undergoing cardiac surgery (CABG, Valve, or CABG and Valve) with cardiopulmonary bypass.
• BMI\<30
• Able, in the opinion of the investigator, and willing to give informed consent.
• Do not have diagnosed coeliac disease
• Able to understand English

You may not qualify if:

• Any of the following:
• Urgent, emergency or salvage procedure
• Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) \<15 mL/min/1.73 m2 calculated from the Modification of Diet in Renal Disease equation,1 or patients who are on long-term haemodialysis or have undergone renal transplantation.
• Patients with persistent or chronic atrial fibrillation.
• Patients with severe liver dysfunction; hepatitis, cirrhosis, jaundice.
• Women who are pregnant or who may become pregnant in the intraoperative period.
• Patients who are participating in another interventional clinical trial.
• Unable, in the opinion of the investigator, or unwilling to give informed consent.
• Have diagnosed coeliac disease
• Unable to understand English
• Permanent pacemaker or ICD
• Brain Aneurysm Clip
• Implanted neural stimulator
• Cochlear implant (specific implant must be checked that it is MR safe)
• Ocular foreign body (e.g. metal shavings) unless removed

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

University of Leicester

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Coronary Artery Disease; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gavin J Murphy, MD

  BHF Professor of Cardiac Surgery, University of Leicester

  STUDY CHAIR

• Mustafa Zakkar, PhD

  Associate Professor, University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Zakkar, PhD

CONTACT

0116258; mz207@le.ac.uk

Hardeep Aujla

CONTACT

0116250; ha200@le.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Unblinded randomised controlled trial

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: July 11, 2019
• Study Start: May 7, 2019
• Primary Completion: April 1, 2024
• Study Completion: October 7, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)