Aortic DiseasesVARIANCENCT03714399
Muscle Recovery Following Aortic Surgery Induced ICUAW.
An observational study of Aortic Diseases and Intensive Care Unit Syndrome, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Diseases, Intensive Care Unit Syndrome, Intensive Care Neuropathy
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Feb 2019to 26 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion criteria include any consenting adult receiving elective aortic surgery at Bartshealth NHS trust with no evidence of pre-hospital neuromuscular conditions.
Who may be able to join
- Above the age of 18
- Receiving elective aortic valvular surgery at Barts Health NHS Trust
Who cannot join
- Previous Stroke
- Neuromuscular disease
- Malignancy
- Underlying neuromuscular disease
- Paediatrics
- Non-consenting adults
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Bartholomew's hospital (Barts NHS trust)
London, EC1A 7BE
About this study
Official title: A Prospective Observational Study Into Muscle Recovery Following Aortic Surgery Induced Intensive Care Unit-acquired Weakness (VARIANCE).
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.
Read the detailed description
The aim is to identify determinants of recovery from intensive care unit-acquired weakness (ICUAW) and to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. This phenomenon has become more evident over recent years and still requires extensive research.
ICUAW is an umbrella term for more specifically, polyneuropathy and myopathy. Recent research has found that 50% of patients undergoing elective cardiac surgery lose significant muscle mass (9.6% in the wasters group) within the first seven days. These patients are receiving relatively uncomplicated surgery yet still suffering from muscle breakdown, which cannot be described by inactivity alone. ICUAW can lead to a significant increase in mortality, morbidity, hospital-acquired infections and pressure ulcers. Risk factors for ICUAW include neuromuscular blocking agents, hyperglycaemia, inactivity and sepsis. The correlation between a relatively homogenous (cardiac surgical) group and patient-centred outcomes during recovery such as functional ability and health-related quality of life (HRQoL) has been little studied.
Patients undergoing elective aortic valvular surgery at St Bartholomew's Hospital London will be recruited for the study. We have chosen the cardiac surgical model due to being a homogenous cohort where the time of insult from surgery from the cardiac bypass, can be measured in correlation with ICUAW. Due to the clamped aorta within the operation, prolonged periods of reduced blood flow to the body occurs, and therefore an element of ischaemia and reperfusion can lead to muscle wasting. Rectus Femoris cross-sectional area (RFcsa) will be measured at pre-determined intervals and the images then greyscaled and muscle quality assessed. To assess and quantify 'good and bad recovery,' we will correlate these tests with functional capacity and HRQoL. Additionally, Blood and urine samples will be taken at pre-defined intervals to observe for markers of oxidative stress, organ injury and molecular profiles. Muscle biopsies will be taken during surgery and observed for histological and fibre profiles.
The primary objective is to identify determinants of recovery from ICUAW and to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after aortic valvular surgery. Specifically, to observe the cross-sectional area of the Rectus Femoris (RFcsa) and correlate this with muscle strength and HRQoL during the recovery phase. The RFcsa, hand-held dynamometry, knee straightening dynamometry, Free Fat Mass Index, standing and lying vital capacity and the short physical performance battery (SPPB) will be observed. Also, HRQoL will be measured using the reintegration to normal living index (RNLI), hospital and anxiety depression score (HADS), EQ-5D-5L (EuroQol research foundation). The primary endpoint will be once all these data are gathered and analysed.
The secondary aim is to understand the molecular and genomic profile of blood samples and the histology of the muscle biopsies. The secondary objective will be supported with additional data from urine analysis (Albumin-creatinine ratio, ACR). The secondary endpoint will be once these data are gathered and analysed.
- 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)
- Medical subject headings
- Aortic Diseases, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Pre-operatively and 6-15 week follow up clinic.
Secondary outcomes (4)
The secondary aim is to understand the molecular profile (bloods).
Blood analysis will contain and analyse but not limited to markers of oxidative stress injury, inflammation, MiRNA and injury to multiple organs will be quantified. We will store Buffy coat and plasma to understand these profiles.
Measured: Pre-operatively, Day 1, Day 3, Day 7/hospital discharge and 6-15 week follow up.
Urine Analysis
Urine analysis observes albumin-creatinine ratio (ACR)
Measured: pre-operatively, Day 1, Day 3, Day 7/hospital discharge and 6-15 week follow up.
Muscle Biopsy
A muscle biopsy will be taken from patients whilst under anaesthesia. The biopsy observes pathways relevant to muscle homeostasis using biochemical and molecular techniques.
Measured: Intra-operatively
Cardiac post operative morbidity score (C-POMS) will be used to calculate morbidity risk.
C-POMS is additional data that will be collected and analysed. C-POMS is a validated tool assessing in-hospital morbidity burden (score 0-13) derived by noting the presence of 13 morbidity domains on days 3, 5, 8 and 15 after surgery. A higher score indicates a greater morbidity burden.
Measured: Day 3, day 5, day 8 and day 15 post cardiac surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start19 Feb 2019
- Primary completion22 Jun 2022
- Study completion26 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London
- Responsible party
- Sponsor
- Investigators
- Mark Grffiths, PhD FRCP, Principal investigator, Substantive Employee and primary supervisor to PhD studentJulie Sanders, MSc, PhD, Principal investigator, Director of research and supervisor to PhD studentAshley Thomas, MSc, Principal investigator, Substantive employee and PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714399
- Sponsor's protocol ID
- 012396 (VARIANCE)
- Acronym
- VARIANCE
- Status last verified
- Nov 2021
- First submitted
- 5 Jun 2018
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25888214
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Into Muscle Recovery Following Aortic Surgery Induced Intensive Care Unit-acquired Weakness (VARIANCE).
- ClinicalTrials.gov ID
- NCT03714399
- Acronym / sponsor ID
- VARIANCE / 012396 (VARIANCE)
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Queen Mary University of London
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim is to identify determinants of recovery from intensive care unit-acquired weakness (ICUAW) and to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. This phenomenon has become more evident over recent years and still requires extensive research.
ICUAW is an umbrella term for more specifically, polyneuropathy and myopathy. Recent research has found that 50% of patients undergoing elective cardiac surgery lose significant muscle mass (9.6% in the wasters group) within the first seven days. These patients are receiving relatively uncomplicated surgery yet still suffering from muscle breakdown, which cannot be described by inactivity alone. ICUAW can lead to a significant increase in mortality, morbidity, hospital-acquired infections and pressure ulcers. Risk factors for ICUAW include neuromuscular blocking agents, hyperglycaemia, inactivity and sepsis. The correlation between a relatively homogenous (cardiac surgical) group and patient-centred outcomes during recovery such as functional ability and health-related quality of life (HRQoL) has been little studied.
Patients undergoing elective aortic valvular surgery at St Bartholomew's Hospital London will be recruited for the study. We have chosen the cardiac surgical model due to being a homogenous cohort where the time of insult from surgery from the cardiac bypass, can be measured in correlation with ICUAW. Due to the clamped aorta within the operation, prolonged periods of reduced blood flow to the body occurs, and therefore an element of ischaemia and reperfusion can lead to muscle wasting. Rectus Femoris cross-sectional area (RFcsa) will be measured at pre-determined intervals and the images then greyscaled and muscle quality assessed. To assess and quantify 'good and bad recovery,' we will correlate these tests with functional capacity and HRQoL. Additionally, Blood and urine samples will be taken at pre-defined intervals to observe for markers of oxidative stress, organ injury and molecular profiles. Muscle biopsies will be taken during surgery and observed for histological and fibre profiles.
The primary objective is to identify determinants of recovery from ICUAW and to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after aortic valvular surgery. Specifically, to observe the cross-sectional area of the Rectus Femoris (RFcsa) and correlate this with muscle strength and HRQoL during the recovery phase. The RFcsa, hand-held dynamometry, knee straightening dynamometry, Free Fat Mass Index, standing and lying vital capacity and the short physical performance battery (SPPB) will be observed. Also, HRQoL will be measured using the reintegration to normal living index (RNLI), hospital and anxiety depression score (HADS), EQ-5D-5L (EuroQol research foundation). The primary endpoint will be once all these data are gathered and analysed.
The secondary aim is to understand the molecular and genomic profile of blood samples and the histology of the muscle biopsies. The secondary objective will be supported with additional data from urine analysis (Albumin-creatinine ratio, ACR). The secondary endpoint will be once these data are gathered and analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria include any consenting adult receiving elective aortic surgery at Bartshealth NHS trust with no evidence of pre-hospital neuromuscular conditions.
Key inclusion criteria (2 listed)
- Above the age of 18
- Receiving elective aortic valvular surgery at Barts Health NHS Trust
Key exclusion criteria (6 listed)
- Previous Stroke
- Neuromuscular disease
- Malignancy
- Underlying neuromuscular disease
- Paediatrics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To observe the change in cross sectional area of the Rectus Femoris (RFcsa) during critical illness and recovery.
Time frame: Pre-operatively, day 7/Hospital Discharge and 6-15week follow up clinic.
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.
To Observe a change in Hand Held Dynamometry strength (grip strength) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Time frame: Pre-operatively, Day 7/Hospital Discharge and 6-15 week follow up clinic.
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.
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.
Time frame: Pre-operatively, Day 7/Hospital Discharge and 6-15 week follow up clinic.
The test will be conducted using a Lafayette Manual Muscle Tester. Joint knee moment (torque) and strength will be measured.
To observe a change in Short Physical Performance Battery (SPPB) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Time frame: Pre-operatively, Day 7/Hospital Discharge and 6-15 week follow up clinic.
SPPB will be measured at similar time points to understand a patients' functional status.
Lying and Standing Vital Capacity (FVC - forced vital capacity) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Time frame: Pre-operatively, Day 7/Hospital Discharge and 6-15 week follow up clinic.
Lying and standing vital capacity will be measured using a hand held spirometer.
To measure Free Fat Mass Index (FFMI) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Time frame: Pre-operatively, Day 7/Hospital Discharge and 6-15 week follow up clinic.
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).
To measure the EQ-5D-5L (Euroscore) to assess general health and correlate this with the primary objective (RFcsa).
Time frame: Pre operatively, Day 7/Hospital discharge and 6-15 week follow up.
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).
Hospital anxiety and depression score (HADS) to assess HRQoL and correlate this with the overall primary objective (RFcsa).
Time frame: Pre-operatively, Day 7/Hospital discharge and 6-15 week follow up.
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.
Reintegration to normal living index (RNLI) to assess HRQoL and correlate this with the overall primary objective (RFcsa).
Time frame: Pre-operatively and 6-15 week follow up clinic.
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.
4 secondary outcomes
The secondary aim is to understand the molecular profile (bloods).
Time frame: Pre-operatively, Day 1, Day 3, Day 7/hospital discharge and 6-15 week follow up.
Urine Analysis
Time frame: pre-operatively, Day 1, Day 3, Day 7/hospital discharge and 6-15 week follow up.
Muscle Biopsy
Time frame: Intra-operatively
Cardiac post operative morbidity score (C-POMS) will be used to calculate morbidity risk.
Time frame: Day 3, day 5, day 8 and day 15 post cardiac surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 25888214Bloch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Grffiths, PhD FRCP principal investigator
Substantive Employee and primary supervisor to PhD student
Julie Sanders, MSc, PhD principal investigator
Director of research and supervisor to PhD student
Ashley Thomas, MSc principal investigator
Substantive employee and PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Diseases and Intensive Care Unit Syndrome, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the change in cross sectional area of the Rectus Femoris (RFcsa) during critical illness and recovery. (time frame: Pre-operatively, day 7/Hospital Discharge and 6-15week follow up clinic.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03714399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.