CharacterisatiON of carDiac funCTion in Intensive Care Unit Survivors of Sepsis. (CONDUCT-ICU)

February 21, 2023 updated by: NHS Greater Glasgow and Clyde

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ICU Survivors of Sepsis

Description

Inclusion Criteria:

  1. Provision of informed consent.
  2. Age > 18 years.
  3. ICU admission with sepsis (According to The Third International Consensus Definitions for Sepsis and Septic Shock [Sepsis-3])17
  4. Ability to comply with study procedures

Exclusion Criteria:

  1. Inability to give informed consent
  2. Pregnancy.
  3. Ongoing participation in any investigational research that may undermine the scientific basis of the study.

  4. Contraindications to magnetic resonance imaging:

    i. 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

  5. Known Coronary Artery Disease
  6. Previous Myocardial Infarction
  7. Chronic Heart Failure prior to ICU admission
  8. Patient receiving immune modulating drug or biologic therapy either long term or during acute admission
  9. Patient considered by the clinical team to be very unlikely to survive to hospital discharge
  10. Hospital Admission because of Covid-19
  11. Patients undergoing treatment for malignancy with systemic anti-cancer therapies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU Survivors of Sepsis
ICU survivors of sepsis who would routinely attend ICU follow-up.
Diagnostic test: CMR
CMR Imaging 6-10 weeks post hospital discharge.
Diagnostic test: hs-troponin
Biomarker of myocardial injury
Diagnostic test: NT-pro BNP
Biomarker for heart failure
Diagnostic test: CRP
Acute phase inflammatory marker
Diagnostic test: IL1-B
Inflammatory biomarker
Diagnostic test: IL-6
Inflammatory Biomarker
Diagnostic test: IL-10
Inflammatory Biomarker
Diagnostic test: TNF-alpha
Inflammatory Biomarker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-10 weeks post hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hs-Troponin (ng/L)
Time Frame: 6-10 weeks post-hospital discharge
Marker of myocardial injury commonly used in clinical practice
6-10 weeks post-hospital discharge
NT-proBNP (pg/ML)
Time Frame: 6-10 weeks post-hospital discharge
Biomarker of myocardial dysfunction used in patients with heart failure and associated conditions.
6-10 weeks post-hospital discharge
CRP (mg/L)
Time Frame: 6-10 weeks post discharge
Acute phase biomarker of inflammation.
6-10 weeks post discharge
IL-10 (pg/ml)
Time Frame: 6-10 weeks post discharge
Inflammatory cytokine thought to inhibit innate immune response.
6-10 weeks post discharge
IL-1B (pg/ml)
Time Frame: 6-10 weeks post discharge
Acute phase inflammatory cytokine and pyrogen.
6-10 weeks post discharge
TNF-alpha (pg/ml)
Time Frame: 6-10 weeks post discharge
Inflammatory cytokine implicated in acute inflammation and targeted for management of inflammatory and autoimmune disease
6-10 weeks post discharge
IL-6 (pg/ml)
Time Frame: 6-10 weeks post discharge
Inflammatory biomarker associated with adverse cardiovascular outcomes and adverse mortality in critically ill patients
6-10 weeks post discharge
Myocardial Native T1 and T2 Mapping
Time Frame: 6-10 weeks post discharge
CMR markers of subtle inflammation and fibrosis commonly examined during CMR imaging.
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
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.
6-10 weeks post discharge
Brief Pain Inventory Score
Time Frame: 6-10 weeks post discharge
Validated Assessment of Pain. Scores of 0 indicate no pain and scores of 10 indicate the 'worst pain you can imagine'.
6-10 weeks post discharge
ID Pain Score
Time Frame: 6-10 weeks post discharge
Validated assessment tool for differentiation of neuropathic pain. Patients describe character of pain using 'yes' or 'no' questions.
6-10 weeks post discharge
EuroQol 5-Dimension (5D) Score
Time Frame: 6-10 weeks post discharge
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
6-10 weeks post discharge
Hospital Anxiety and Depression Score
Time Frame: 6-10 weeks post discharge
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)
6-10 weeks post discharge
Dukes Activity Status Index
Time Frame: 6-10 weeks post discharge
Validated tool for assessing functional capacity. Scores 0 - 58.2, with higher scores indicating better functional capacity.
6-10 weeks post discharge
Vitality Domain of Short Form 36 - Score
Time Frame: 6-10 weeks post discharge
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.
6-10 weeks post discharge
MRC Breathlessness Scale
Time Frame: 6-10 weeks post discharge
Widely used grading system for breathlessness in survivors of critical illness. Graded 0-4.4 indicates more severe breathlessness.
6-10 weeks post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Glasgow
NHS Ayrshire and Arran
Golden Jubilee National Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN22CA029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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