Muscle Recovery Following Aortic Surgery Induced ICUAW.

NCT03714399 | Completed

• 1 other identifier: 012396 (VARIANCE)
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

To identify determinants of 'good and bad recovery' from ICUAW and build knowledge around the timing of these processes. Also, the investigators want to discover the effects of ICUAW on physical function and HRQoL following aortic surgery.

Conditions

Aortic Diseases; Intensive Care Unit Syndrome; Intensive Care Neuropathy; Intensive Care (ICU) Myopathy; Critical Illness Myopathy; Surgery

Keywords

Intensive Care Unit Acquired Weakness (ICUAW); Critical Illness Polyneuromyopathy (CIPM); Health Related Quality of Life (HRQoL); Ultrasound (US); Cardiac Surgery; Rectus Femoris Cross Sectional Area (RFcsa)

Outcome Measures

Primary Outcomes (9)

• To observe the change in cross sectional area of the Rectus Femoris (RFcsa) during critical illness and recovery.

  RFcsa will be calculated using B-mode ultrasound (US) at pre-determined time points. Additionally, the images acquired will have histogram analysis in adobe photoshop software. The RFcsa will be correlated with indices of muscle strength and HRQoL.

  Pre-operatively, day 7/Hospital Discharge and 6-15week follow up clinic.

• To Observe a change in Hand Held Dynamometry strength (grip strength) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.

  Hand-held dynamometry will be calculated using the JAMAR hand-held hydraulic dynamometer. We will assess both hands and take the mean of 3 trials, producing a maximal grip result.

  Pre-operatively, Day 7/Hospital Discharge and 6-15 week follow up clinic.

• To observe a change in Knee straightening dynamometry, strength and joint moment (torque) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.

  The test will be conducted using a Lafayette Manual Muscle Tester. Joint knee moment (torque) and strength will be measured.

  Pre-operatively, Day 7/Hospital Discharge and 6-15 week follow up clinic.

• To observe a change in Short Physical Performance Battery (SPPB) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.

  SPPB will be measured at similar time points to understand a patients' functional status.

  Pre-operatively, Day 7/Hospital Discharge and 6-15 week follow up clinic.

• Lying and Standing Vital Capacity (FVC - forced vital capacity) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.

  Lying and standing vital capacity will be measured using a hand held spirometer.

  Pre-operatively, Day 7/Hospital Discharge and 6-15 week follow up clinic.

• To measure Free Fat Mass Index (FFMI) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.

  Free fat mass index (FFMI) and free fat mass (FFM) will be measured using the bodystat 1500 device. Other values will also be recorded from the test including body fat percentage and lean mass percentage. The body stat 1500 is an electrical device that uses electrical impedance to obtain results (objective data).

  Pre-operatively, Day 7/Hospital Discharge and 6-15 week follow up clinic.

• To measure the EQ-5D-5L (Euroscore) to assess general health and correlate this with the primary objective (RFcsa).

  EQ5D-5L is a standardised tool that provides a simple generic measure of health. A summation of all the levels will be converted to a single index value using the EQ5D-5L crosswalk index value calculator. The general health score can range from 0 (worst health imaginable) to 100 (best health imaginable).

  Pre operatively, Day 7/Hospital discharge and 6-15 week follow up.

• Hospital anxiety and depression score (HADS) to assess HRQoL and correlate this with the overall primary objective (RFcsa).

  The HADS is an assessment that measures whether a patients is suffering from anxiety or depression. HADS is a self assessment consisting of 16 items. A result of between 0 and 7 indicates a normal case, between 8 and 10 indicates borderline abnormal and between 11 and 21 indicates abnormal levels of anxiety and depression.

  Pre-operatively, Day 7/Hospital discharge and 6-15 week follow up.

• Reintegration to normal living index (RNLI) to assess HRQoL and correlate this with the overall primary objective (RFcsa).

  The RNLI is a 5 domain 11-tool item aimed at assessing the degree to which patients' who have experiences traumatic and incapacitating illness achieve reintegration into society. The RNLI score is based out of 110, which will be proportionally converted to create a score of 100. Zero indicates no integration whereas 100 implies full integration.

  Pre-operatively and 6-15 week follow up clinic.

Secondary Outcomes (4)

• The secondary aim is to understand the molecular profile (bloods).

  Pre-operatively, Day 1, Day 3, Day 7/hospital discharge and 6-15 week follow up.

• Urine Analysis

  pre-operatively, Day 1, Day 3, Day 7/hospital discharge and 6-15 week follow up.

• Muscle Biopsy

  Intra-operatively

• Cardiac post operative morbidity score (C-POMS) will be used to calculate morbidity risk.

  Day 3, day 5, day 8 and day 15 post cardiac surgery.

Study Arms (1)

ICUAW group

The physical and psychological effects of ICUAW on patients undergoing aortic valvular surgery will be observed. Physical function and HRQoL will be analysed and correlated with RFcsa. Additionally, biological markers will be used to understand molecular and genomic profiles.

Eligibility Criteria

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

Study Population

Inclusion criteria include any consenting adult receiving elective aortic surgery at Bartshealth NHS trust with no evidence of pre-hospital neuromuscular conditions.

You may qualify if:

• Above the age of 18
• Receiving elective aortic valvular surgery at Barts Health NHS Trust

You may not qualify if:

• Previous Stroke
• Neuromuscular disease
• Malignancy
• Underlying neuromuscular disease
• Paediatrics
• Non-consenting adults

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Queen Mary University of London: collaborator

Study Sites (1)

St Bartholomew's hospital (Barts NHS trust)

London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

• Bloch SA, Donaldson AV, Lewis A, Banya WA, Polkey MI, Griffiths MJ, Kemp PR. MiR-181a: a potential biomarker of acute muscle wasting following elective high-risk cardiothoracic surgery. Crit Care. 2015 Apr 7;19(1):147. doi: 10.1186/s13054-015-0853-5.

  PMID: 25888214 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Muscle biopsies attained during surgery from the thigh and chest wall will undergo histological analysis. Blood samples (plasma and buffy coat) will also be analysed for mediators and markers of oxidative stress injury (e.g. 8-isoprostane), inflammation (e.g. GDF-15 and soluble tumour necrosis factor receptor) and injury to multiple organs will be quantified. Urine will be used to measure albumin-creatinine ratio (ACR) as a marker of endothelial injury.

MeSH Terms

Conditions

Aortic Diseases; Muscular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Mark Grffiths, PhD FRCP

  Substantive Employee and primary supervisor to PhD student

  PRINCIPAL INVESTIGATOR

• Julie Sanders, MSc, PhD

  Director of research and supervisor to PhD student

  PRINCIPAL INVESTIGATOR

• Ashley Thomas, MSc

  Substantive employee and PhD student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: October 22, 2018
• Study Start: February 19, 2019
• Primary Completion: June 22, 2022
• Study Completion: September 26, 2022
• Last Updated: October 4, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)