Heart FailureCONDUCT-ICUNCT05633290
CharacterisatiON of carDiac funCTion in Intensive Care Unit Survivors of Sepsis.
An observational study of Heart Failure and Myocarditis, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
Trial summary
Cardiac dysfunction is common following hospital admission with sepsis and one of the most frequent causes for readmissions to hospital, however underlying mechanisms by which this might occur are unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Myocarditis, Sepsis
- What is being tested?
- CMR, hs-troponin and NT-pro BNP
- How many people
- 69 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Mar 2023to Feb 2024
- 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: ICU Survivors of Sepsis
Who may be able to join
- Provision of informed consent.
- Age > 18 years.
- ICU admission with sepsis (According to The Third International Consensus Definitions for Sepsis and Septic Shock [Sepsis-3])17
- Ability to comply with study procedures
Who cannot join
- Inability to give informed consent
- Pregnancy.
- Ongoing participation in any investigational research that may undermine the scientific basis of the study.
- Contraindications to magnetic resonance imaging:
- Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant ii. Aneurysm clips iii. Metal injuries to the eye iv. Loose metal in any part of the body v. Severe claustrophobia
- Known Coronary Artery Disease
Show all 12Show fewer
- Previous Myocardial Infarction
- Chronic Heart Failure prior to ICU admission
- Patient receiving immune modulating drug or biologic therapy either long term or during acute admission
- Patient considered by the clinical team to be very unlikely to survive to hospital discharge
- Hospital Admission because of Covid-19
- Patients undergoing treatment for malignancy with systemic anti-cancer therapies.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Glasgow Royal Infirmary
Glasgow, G4 0SF
Kevin M Garrity, MBChB, 0141 201 5429, kevin.garrity@glasgow.ac.uk
Christie Docherty, MBChB, 01412015429, Christie.Docherty@glasgow.ac.uk
- Recruiting
University Hospital Crosshouse
Kilmarnock, KA2 0BE
Dr Christie Docherty, MDChB, 0141 201 5429, Christie.Docherty@glasgow.ac.uk
Kevin Garrity, MBChB, 0141 201 5429, Kevin.Garrity@glasgow.ac.uk
About this study
Official title: CharacterisatiON of carDiac funCTion in Intensive Care Unit Survivors of Sepsis (CONDUCT-ICU): A Pilot Study
Cardiac dysfunction is common following hospital admission with sepsis and one of the most frequent causes for readmissions to hospital, however underlying mechanisms by which this might occur are unclear. The CONDUCT-ICU investigators will conduct a pilot, cohort study, characterizing cardiac function in ICU survivors of sepsis using a combination of CMR imaging, biomarkers and patient reported outcome measures to investigate mechanisms of cardiac dysfunction following sepsis. Comparisons will be made to that of the general population.
Read the detailed description
Sepsis is one of the most common reasons for admission to ICU in the UK and it is well established that adverse cardiovascular events are common following sepsis. In fact, the risk of adverse cardiovascular events such as MI, Heart Failure and Stroke is in excess of 60% greater compared to those who have not had sepsis. Similarly, heart failure is one of the most common causes of readmission to hospital following an episode of sepsis. The underlying mechanisms for this phenomenon are unclear and CONDUCT-ICU investigators intend on answering this question.
Investigators will collect cardiac and inflammatory biomarkers from participants at the point of discharge from ICU. Following discharge from hospital, cardiac magnetic resonance (CMR) scans of the heart will be undertaken in participants 6-10 weeks post-discharge from hospital to examine for evidence of inflammation in the heart. Further blood samples will also be collected to look for evidence of inflammation and heart muscle injury at this point in addition to patient reported outcomes measures using validated questionnaires.
Participants will be identified with their direct clinical team in ICU and are nearing or at the point of discharge from ICU. If eligible for the study, they will be approached by researchers and provided them with an information sheet and written consent form. Participants will be given up to 24hrs to decide if they wish to take part in research and if so, they will sign the consent form. Participants are free to withdraw from the study at any time, without any reason given, and this would not affect the standard of care they receive.
This is an observational cohort study. If willing to take part, participants will receive the normal follow-up that would be undertaken following discharge from ICU. In addition, researchers will collect a sample of blood from participants at the time of discharge from ICU and again at 6 -10 weeks post discharge. A Cardiac Magnetic Resonance (CMR) scan will be undertaken 6-10 weeks follow up.
Researchers will assess the patient's day-to-day function and quality of life by asking them to complete validated questionnaires. These questionnaires should take five to ten minutes to complete and help will be available if required. Participants will complete these questionnaires at the follow-up visit 6-10 weeks following discharge from hospital with the help of the researchers conducting the study
The first blood sample will be collected following discharge from ICU whilst the patient is still in hospital. Further blood samples will be collected 6-10 weeks following discharge from hospital. Blood samples for patients undergoing CMR will be taken when they attend for scan. Blood sampling for patients who do not undergo CMR imaging will attend for a separate follow-up visit for collection of samples.
Patients are normally invited to attend ICU follow-up via the InS:PIRE service at approximately 6-10 weeks post-discharge. Where possible researchers will combine blood sample analysis with routine follow-up visits in clinic to which participants would normally be invited. If they are not able to attend follow-up and are not attending for CMR scan, then researchers will invite them to the research facility within the local sites for collection of samples.
Samples will be stored in NHS Biorepository and analyzed within the British Heart Foundation Laboratory at the University of Glasgow.
- Conditions
- Heart Failure, Myocarditis, Sepsis, Septic Shock
- Being tested
- CMR, hs-troponin, NT-pro BNP, CRP, IL1-B
- Medical subject headings
- Heart Failure, Myocarditis, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMRDiagnostic test
CMR Imaging 6-10 weeks post hospital discharge.
hs-troponinDiagnostic test
Biomarker of myocardial injury
NT-pro BNPDiagnostic test
Biomarker for heart failure
CRPDiagnostic test
Acute phase inflammatory marker
IL1-BDiagnostic test
Inflammatory biomarker
IL-6Diagnostic test
Inflammatory Biomarker
IL-10Diagnostic test
Inflammatory Biomarker
TNF-alphaDiagnostic test
Inflammatory Biomarker
| Study group | Role | What they receive |
|---|---|---|
| ICU Survivors of Sepsis | ICU survivors of sepsis who would routinely attend ICU follow-up. Receives: Diagnostic Test: CMR; Diagnostic Test: hs-troponin; Diagnostic Test: NT-pro BNP; Diagnostic Test: CRP; Diagnostic Test: IL1-B; Diagnostic Test: IL-6; Diagnostic Test: IL-10; Diagnostic Test: TNF-alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction
LVEF is a validated marker of cardiovascular function. It can be used in diagnosis of heart failure and can assist in grading severity.
Measured: 6-10 weeks post hospital discharge
Secondary outcomes (16)
hs-Troponin (ng/L)
Marker of myocardial injury commonly used in clinical practice
Measured: 6-10 weeks post-hospital discharge
NT-proBNP (pg/ML)
Biomarker of myocardial dysfunction used in patients with heart failure and associated conditions.
Measured: 6-10 weeks post-hospital discharge
CRP (mg/L)
Acute phase biomarker of inflammation.
Measured: 6-10 weeks post discharge
IL-10 (pg/ml)
Inflammatory cytokine thought to inhibit innate immune response.
Measured: 6-10 weeks post discharge
IL-1B (pg/ml)
Acute phase inflammatory cytokine and pyrogen.
Measured: 6-10 weeks post discharge
TNF-alpha (pg/ml)
Inflammatory cytokine implicated in acute inflammation and targeted for management of inflammatory and autoimmune disease
Measured: 6-10 weeks post discharge
IL-6 (pg/ml)
Inflammatory biomarker associated with adverse cardiovascular outcomes and adverse mortality in critically ill patients
Measured: 6-10 weeks post discharge
Brief Pain Inventory Score
Validated Assessment of Pain. Scores of 0 indicate no pain and scores of 10 indicate the 'worst pain you can imagine'.
Measured: 6-10 weeks post discharge
ID Pain Score
Validated assessment tool for differentiation of neuropathic pain. Patients describe character of pain using 'yes' or 'no' questions.
Measured: 6-10 weeks post discharge
EuroQol 5-Dimension (5D) Score
Validated measure of quality of life. Part of core outcome measures in critical illness survivors. Scores 5 domains (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety /Depression) on likert scale as follows: 1) No problems, 2) Slight Problems, 3) Moderate Problems, 4) Severe Problems, 5) Unable
Measured: 6-10 weeks post discharge
Hospital Anxiety and Depression Score
Validated measure of anxiety and depression. Previously used in survivors of critical illness. Total score: 0-7 = Normal, 8-10 Borderline abnormal (borderline case), 11-21 Abnormal (case)
Measured: 6-10 weeks post discharge
Dukes Activity Status Index
Validated tool for assessing functional capacity. Scores 0 - 58.2, with higher scores indicating better functional capacity.
Measured: 6-10 weeks post discharge
Vitality Domain of Short Form 36 - Score
Validated tool for vitality and used in survivors of critical illness. Likert Scale Assessing vitality. Answers range from 1)All of the time, most of the time, a good bit of the time, some of the time, a little bit of the time, none of the time.
Measured: 6-10 weeks post discharge
MRC Breathlessness Scale
Widely used grading system for breathlessness in survivors of critical illness. Graded 0-4.4 indicates more severe breathlessness.
Measured: 6-10 weeks post discharge
Myocardial Native T1 and T2 Mapping
CMR markers of subtle inflammation and fibrosis commonly examined during CMR imaging.
Measured: 6-10 weeks post discharge
Successful follow-up rate of participants invited to attend CMR scans. i.e. Feasibility of CMR imaging
To evaluate feasibility of undertaking CMR in complex post-ICU cohort of patients. To the investigators' best knowledge, this cohort has never been investigated before in this way and it is unclear to what extent participants will be able to attend follow up. We will evaluate the attendance rate at CMR follow-up measured against participants invited to take part in the study.
Measured: 6-10 weeks post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Mar 2023
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
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 Heart FailureStudies 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
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Ayrshire and Arran, Golden Jubilee National Hospital, University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633290
- Sponsor's protocol ID
- GN22CA029
- Acronym
- CONDUCT-ICU
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garrity K, Docherty C, Mangion K, Woodward R, Shaw M, Roditi G, Shelley B, Quasim T, McCall P, McPeake J. Characterizing Cardiac Function in ICU Survivors of Sepsis: A Pilot Study Protocol. CHEST Crit Care. 2024 Mar;2(1):100050. doi: 10.1016/j.chstcc.2024.100050.
PubMed 38524255
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CharacterisatiON of carDiac funCTion in Intensive Care Unit Survivors of Sepsis (CONDUCT-ICU): A Pilot Study
- ClinicalTrials.gov ID
- NCT05633290
- Acronym / sponsor ID
- CONDUCT-ICU / GN22CA029
- Conditions
- Heart Failure, Myocarditis, Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- NHS Ayrshire and Arran, Golden Jubilee National Hospital, University of Glasgow
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 1 Dec 2022 (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.
Cardiac dysfunction is common following hospital admission with sepsis and one of the most frequent causes for readmissions to hospital, however underlying mechanisms by which this might occur are unclear. The CONDUCT-ICU investigators will conduct a pilot, cohort study, characterizing cardiac function in ICU survivors of sepsis using a combination of CMR imaging, biomarkers and patient reported outcome measures to investigate mechanisms of cardiac dysfunction following sepsis. Comparisons will be made to that of the general population.
Detailed description
Sepsis is one of the most common reasons for admission to ICU in the UK and it is well established that adverse cardiovascular events are common following sepsis. In fact, the risk of adverse cardiovascular events such as MI, Heart Failure and Stroke is in excess of 60% greater compared to those who have not had sepsis. Similarly, heart failure is one of the most common causes of readmission to hospital following an episode of sepsis. The underlying mechanisms for this phenomenon are unclear and CONDUCT-ICU investigators intend on answering this question.
Investigators will collect cardiac and inflammatory biomarkers from participants at the point of discharge from ICU. Following discharge from hospital, cardiac magnetic resonance (CMR) scans of the heart will be undertaken in participants 6-10 weeks post-discharge from hospital to examine for evidence of inflammation in the heart. Further blood samples will also be collected to look for evidence of inflammation and heart muscle injury at this point in addition to patient reported outcomes measures using validated questionnaires.
Participants will be identified with their direct clinical team in ICU and are nearing or at the point of discharge from ICU. If eligible for the study, they will be approached by researchers and provided them with an information sheet and written consent form. Participants will be given up to 24hrs to decide if they wish to take part in research and if so, they will sign the consent form. Participants are free to withdraw from the study at any time, without any reason given, and this would not affect the standard of care they receive.
This is an observational cohort study. If willing to take part, participants will receive the normal follow-up that would be undertaken following discharge from ICU. In addition, researchers will collect a sample of blood from participants at the time of discharge from ICU and again at 6 -10 weeks post discharge. A Cardiac Magnetic Resonance (CMR) scan will be undertaken 6-10 weeks follow up.
Researchers will assess the patient's day-to-day function and quality of life by asking them to complete validated questionnaires. These questionnaires should take five to ten minutes to complete and help will be available if required. Participants will complete these questionnaires at the follow-up visit 6-10 weeks following discharge from hospital with the help of the researchers conducting the study
The first blood sample will be collected following discharge from ICU whilst the patient is still in hospital. Further blood samples will be collected 6-10 weeks following discharge from hospital. Blood samples for patients undergoing CMR will be taken when they attend for scan. Blood sampling for patients who do not undergo CMR imaging will attend for a separate follow-up visit for collection of samples.
Patients are normally invited to attend ICU follow-up via the InS:PIRE service at approximately 6-10 weeks post-discharge. Where possible researchers will combine blood sample analysis with routine follow-up visits in clinic to which participants would normally be invited. If they are not able to attend follow-up and are not attending for CMR scan, then researchers will invite them to the research facility within the local sites for collection of samples.
Samples will be stored in NHS Biorepository and analyzed within the British Heart Foundation Laboratory at the University of Glasgow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Survivors of Sepsis | – | Diagnostic Test: CMR, Diagnostic Test: hs-troponin, Diagnostic Test: NT-pro BNP, Diagnostic Test: CRP, Diagnostic Test: IL1-B, Diagnostic Test: IL-6, Diagnostic Test: IL-10, Diagnostic Test: TNF-alphaICU survivors of sepsis who would routinely attend ICU follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU Survivors of Sepsis
Key inclusion criteria (4 listed)
- Provision of informed consent.
- Age > 18 years.
- ICU admission with sepsis (According to The Third International Consensus Definitions for Sepsis and Septic Shock [Sepsis-3])17
- Ability to comply with study procedures
Key exclusion criteria (12 listed)
- Inability to give informed consent
- Pregnancy.
- Ongoing participation in any investigational research that may undermine the scientific basis of the study.
- Contraindications to magnetic resonance imaging:
- Known Coronary Artery Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMRCMR Imaging 6-10 weeks post hospital discharge. | Diagnostic test | ICU Survivors of Sepsis |
| hs-troponinBiomarker of myocardial injury | Diagnostic test | ICU Survivors of Sepsis |
| NT-pro BNPBiomarker for heart failure | Diagnostic test | ICU Survivors of Sepsis |
| CRPAcute phase inflammatory marker | Diagnostic test | ICU Survivors of Sepsis |
| IL1-BInflammatory biomarker | Diagnostic test | ICU Survivors of Sepsis |
| IL-6Inflammatory Biomarker | Diagnostic test | ICU Survivors of Sepsis |
| IL-10Inflammatory Biomarker | Diagnostic test | ICU Survivors of Sepsis |
| TNF-alphaInflammatory Biomarker | Diagnostic test | ICU Survivors of Sepsis |
Primary outcome
Left Ventricular Ejection Fraction
Time frame: 6-10 weeks post hospital discharge
LVEF is a validated marker of cardiovascular function. It can be used in diagnosis of heart failure and can assist in grading severity.
16 secondary outcomes
hs-Troponin (ng/L)
Time frame: 6-10 weeks post-hospital discharge
NT-proBNP (pg/ML)
Time frame: 6-10 weeks post-hospital discharge
CRP (mg/L)
Time frame: 6-10 weeks post discharge
IL-10 (pg/ml)
Time frame: 6-10 weeks post discharge
IL-1B (pg/ml)
Time frame: 6-10 weeks post discharge
TNF-alpha (pg/ml)
Time frame: 6-10 weeks post discharge
IL-6 (pg/ml)
Time frame: 6-10 weeks post discharge
Brief Pain Inventory Score
Time frame: 6-10 weeks post discharge
ID Pain Score
Time frame: 6-10 weeks post discharge
EuroQol 5-Dimension (5D) Score
Time frame: 6-10 weeks post discharge
Hospital Anxiety and Depression Score
Time frame: 6-10 weeks post discharge
Dukes Activity Status Index
Time frame: 6-10 weeks post discharge
Vitality Domain of Short Form 36 - Score
Time frame: 6-10 weeks post discharge
MRC Breathlessness Scale
Time frame: 6-10 weeks post discharge
Myocardial Native T1 and T2 Mapping
Time frame: 6-10 weeks post discharge
Successful follow-up rate of participants invited to attend CMR scans. i.e. Feasibility of CMR imaging
Time frame: 6-10 weeks post discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 38524255Garrity K, Docherty C, Mangion K, Woodward R, Shaw M, Roditi G, Shelley B, Quasim T, McCall P, McPeake J. Characterizing Cardiac Function in ICU Survivors of Sepsis: A Pilot Study Protocol. CHEST Crit Care. 2024 Mar;2(1):100050. doi: 10.1016/j.chstcc.2024.100050.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Myocarditis, run by NHS Greater Glasgow and Clyde at 2 sites 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip McCall, MBChB, MD (0141 951 5000, philip.mccall@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction (time frame: 6-10 weeks post hospital discharge). 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 NCT05633290, 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 8 Mar 2023.