An observational study in Right Ventricular Dysfunction, sponsored by NHS National Waiting Times Centre Board. Not yet recruiting at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by NHS National Waiting Times Centre Board · Observational
A study to see how common right heart failure (right ventricular dysfunction) after major surgery is, and to investigate if right ventricular dysfunction causes worse patient outcomes after surgery.
Heart attacks are relatively rare around the time of surgery, however by measuring blood markers of heart injury, recent research has revealed that heart injury which otherwise may not be immediately obvious is common. Whilst this type of heart injury appears to be strongly linked to patient outcomes (complications, recovery and survival), the causes and potential treatments for it are not well understood.
Our research group has specialist knowledge about the right-hand side of the heart (right-heart) - the side that pumps blood through the lungs - which is less commonly considered or studied around the time of surgery. We have shown in previous studies using magnetic resonance imaging (MRI) scans (specialised whole-body scans which use a magnet rather than X-rays), evidence of right-heart function deteriorating after surgery. We want to test the idea that some of the blood marker evidence of heart injury reflects injury to the right-heart and more importantly that we can protect the right-heart around the time of surgery, reducing injury and improving patient outcomes.
We will examine these questions in the following ways:
This study will give us a better understanding of which patients are likely to suffer heart injury around the time of surgery and how this injury occurs. With this knowledge, future patients could receive personalised treatment plans aimed at preventing injury and improving outcomes. We are not testing any new treatments in this study.
90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.
This study's planned enrollment of 175 is above the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.
Browse Ventricular Dysfunction, Right studies →NHS National Waiting Times Centre Board is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
175 patients of 18 years or older undergoing major non-cardiac surgery in the West of Scotland. Patients will be recruited from the Golden Jubilee National Hospital, Queen Elizabeth University Hospital, and Glasgow Royal Infirmary.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Main echocardiography study
Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria applicable to the T1 CMR sub-study includes:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
35 patients undergoing thoracic surgery with lung resection and one lung ventilation under primarily general anaesthesia.
Diagnostic Test: Echocardiography · Diagnostic Test: T1 Cardiovascular Magnetic Resonance · Diagnostic Test: Right heart catheterisation and coronary sinus blood sampling
35 patients undergoing upper gastrointestinal surgery with one lung ventilation under primarily general anaesthesia.
Diagnostic Test: Echocardiography · Diagnostic Test: T1 Cardiovascular Magnetic Resonance
35 patients undergoing elective colorectal surgery under primarily general anaesthesia.
Diagnostic Test: Echocardiography · Diagnostic Test: T1 Cardiovascular Magnetic Resonance
35 patients undergoing elective open abdominal aortic surgery under primarily general anaesthesia.
Diagnostic Test: Echocardiography · Diagnostic Test: T1 Cardiovascular Magnetic Resonance
35 patients undergoing elective primary hip or knee arthroplasty under spinal anaesthesia +/- sedation.
Diagnostic Test: Echocardiography · Diagnostic Test: T1 Cardiovascular Magnetic Resonance
Echocardiography will be performed by BSE accredited echocardiographers in all 175 patients preoperatively and on day 2-4 postoperatively.
T1 CMR will be performed in 10 patients from each of the 5 surgical groups (50 patients in total) preoperatively and on day 2-4 postoperatively.
10 patients from the thoracic surgical group will undergo right heart catheterisation and coronary sinus blood sampling.
Incidence of postoperative Right ventricular dysfunction (RVD)
RVD diagnosed by transthoracic echocardiography, defined as: * 2D-speckle tracking derived RV free wall peak longitudinal strain (FWLS) less negative than -20%. * Or, (where not available) two of Tricuspid Annular Plane Systolic Excursion (TAPSE) \<16mm, S' Wave velocity at the tricuspid annulus \<10cm/s or tissue doppler RV index of myocardial performance \>0.55
Time frame: Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in RV function
Days alive and at home at 30 days postoperatively (DAH30)
DAH30 is a continuous number between 0 and 30 which reflects, out of the 30 days following surgery, the total number of those days that a patient spends alive and at home. If a patient dies within those 30 days, their value is set to 0. Data for DAH30 will be obtained by follow-up phone calls following the 30th postoperative day.
Time frame: Day 30 postoperatively
Incidence of postoperative left ventricular dysfunction (LVD)
LVD classified as mild, moderately or severely impaired, defined by 2D-echocardiography derived biplane LV ejection fraction and the presence of wall motion abnormalities.
Time frame: Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in LV function
Cardiac biomarkers
Natriuretic peptides and high sensitivity troponin will be measured pre- and postoperatively.
Time frame: BNP and troponin measured preoperatively, on postoperative days 1 and 2 and on day of postoperative echocardiography (occurring on postoperative days 2-4).
Cardiovascular complications
Incidence of myocardial infarction, cardiac death, non-fatal cardiac arrest, coronary revascularisation, pulmonary embolus, deep-veined thrombosis, or new onset atrial fibrillation, and major adverse cardiac events
Time frame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Renal outcomes
Kidney Disease Improving Global Outcome (KDIGO) classification of Acute Kidney Injury (AKI).
Time frame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Pulmonary outcomes
Atelectasis, pneumonia, acute respiratory distress syndrome or pulmonary aspiration
Time frame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Infection Outcomes
Fever and clinical suspicion of infection
Time frame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Neurological outcomes
Delirium and stroke
Time frame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Sequential Organ Failure Assessment (SOFA) Score
Score 0-24, where higher scores are a worse outcome.
Time frame: Postoperative day 1,2, day of postoperative echocardiography in all patients. In patients admitted to HDU/ICU, SOFA score will be collected from postoperative day 0-7.
Fifteen-point Quality of Recovery Score (QoR-15)
Fifteen questions assessing the quality of a patients recovery, each question is scored 0-10 with higher scores indicating a worse outcome.
Time frame: Pre-operatively and day of postoperative echocardiography (day 2-4 postoperatively).
World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
WHODAS 2.0 is a self administered questionnaire that assesses a patient's health and disability. Twelve questions are scored 0-4, where a higher score indicates a worse outcome.
Time frame: Preoperatively, and at day 30, day 90, and one year postoperatively.
EuroQoL Dimension Health Related Quality of Life Questionnaire (EQ-5D-5L)
EQ-5D-5L is a self administered questionnaire that assesses 5 dimensions of a patient's quality of life. Each dimension is scored 1-5, where a higher score indicates a worse outcome.
Time frame: Preoperatively, and at day 30, day 90, and one year postoperatively.
Plan to share: No
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This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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