Health TrialsbyHealthPanel

Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)

ConditionsAortic Valve DiseaseSurgery--ComplicationsImmune System Disorder
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust

About this trial

There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are exposed during surgery.

The investigators have previously demonstrated that having higher pre-operative antibody levels is associated with a lower risk of infection and a shorter stay in hospital after cardiac surgery.

The investigators aim to study 150 patients undergoing aortic valve replacement and explore their dynamic immune responsiveness. The investigators will determine if this response is correlated with the post-operative outcome (development of post-operative infection or increased length of hospital stay).

The investigators will compare this response with the previously measured static markers of immune competence and also with a novel device that may give a more rapid measure of dynamic immunity.

The investigators will approach patients in the cardiac surgical pre-assessment clinic to see if they are willing to participate in the study.

Immediately once under anaesthetic blood will be taken for testing and then again at the end of surgery, 24h after surgery, at discharge from hospital, and at follow-up clinic approximately 4 weeks later. There will be no additional needle insertions on top of those routinely performed. The investigators will collect data from the routine observations as far as 1 year after surgery.

If the investigators can show an association between immune function and subsequent post-operative outcome it may be possible to determine ways to improve outcomes for patients undergoing heart surgery.

This might include better information on risks and benefits of surgery, actively boosting immune function (vaccination, immune-nutrition), passively improving immunity (administering antibodies), or consider current alternatives to open heart surgery where the threat of infection or inflammation may be markedly reduced (eg trans-catheter aortic valve implantation)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Age less than 18y (capacity to consent)

Ongoing sepsis (immunomodulatory effects, established influence on outcome from surgery)

Immunosuppressive therapy

Suffering from known immunosuppressive disease

Trial population

All adult patients undergoing first-time aortic valve replacement that do not fulfil any of the exclusion criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Aortic valve replacement

    Procedure/Surgery

    Open surgical replacement of aortic valve

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Number of participants who develop any post operative, healthcare associated infection.

Development of post-operative healthcare associated infection as defined in the Centre for Disease Control and National Healthcare Safety Network guidance.

Time frame
Development of a HealthCare Associated Infection (HCAI) will be evaluated at one year from date of discharge from hospital.

Secondary outcomes

1

Post-operative length of stay

Time spent in hospital following surgery measured in days

Time frame
Will be assessed at study completion, at one year following discharge from hospital.
2

Correlation of pre-operative antibody levels with in vitro immune response profiles

Determining if there is a correlation between those patients with low antibody levels pre-operatively to endotoxin core and staphylococcal epitopes with the dynamic immune responsiveness in an in vitro test of immune response

Time frame
2 years
3

Does the result from a simple, point of care test of immune function correlate with that from a more comprehensive, laboratory based test of immune function

To determine whether the result obtained from a bedside test of immune function (LITTM) correlates with the result obtained from an in-vitro, laboratory-based test of immune function. The bedside test relies on the chemiluminescence result from a supramaximal stimulus of neutrophils and gives a result in the form of a continuous variable, allowing the ranking of the subjects in order of their neutrophil responsiveness. The laboratory-based tests, performed using flow cytometry, will look at the immune function of monocytes and each assay of a number of cytokines and cell markers will give results as a continuous variable. This again will allow for an overall ranking of patients in terms of the value obtained for each parameter measured. Participants will also be ranked according to the summed rank positions for each variable. Correlation between the rank order of patients determined by the two separate assays of function will be compared by calculating correlation coefficient.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barts & The London NHS Trust

Lead sponsor

University College, London

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: