Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)

NCT04430972 | Not Yet Recruiting

• 1 other identifier: 263703
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Aortic Valve Disease; Surgery--Complications; Immune System Disorder

Keywords

staphylococcus; EndoCAb; Immunity; Cardiac Surgical Procedure; sepsis

Outcome Measures

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.

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

Secondary Outcomes (3)

• Post-operative length of stay

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

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

  2 years

• 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

  2 years

Interventions

Aortic valve replacement PROCEDURE

Open surgical replacement of aortic valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients undergoing first-time open aortic valve replacement surgery

You may not qualify if:

• Age less than 18y (capacity to consent)
• Ongoing sepsis (immunomodulatory effects, established influence on outcome from surgery)
• Immunosuppressive therapy
• Suffering from known immunosuppressive disease
• Pregnancy (immunosuppressive aspects to pregnancy)

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• University College, London: collaborator

Study Sites (1)

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Related Publications (6)

• Smith A, Moravcova S, Treibel TA, Colque-Navarro P, Mollby R, Moon JC, Hamilton-Davies C. Relationship between endotoxin core, staphylococcal and varicella antibody levels and outcome following aortic valve replacement surgery: a prospective observational study. Perioper Med (Lond). 2018 Sep 20;7:20. doi: 10.1186/s13741-018-0101-z. eCollection 2018.

  PMID: 30250733 RESULT

• Moravcova S, Kyle B, Shanahan H, Giannaris S, Smith A, Hamilton-Davies C. Variability of anti-staphylococcal antibodies in healthy volunteers and pre-cardiac surgery patients. Perioper Med (Lond). 2016 May 27;5:13. doi: 10.1186/s13741-016-0039-y. eCollection 2016.

  PMID: 27239299 RESULT

• Hamilton-Davies C, Barclay GR, Cardigan RA, McDonald SJ, Purdy G, Machin SJ, Webb AR. Relationship between preoperative endotoxin immune status, gut perfusion, and outcome from cardiac valve replacement surgery. Chest. 1997 Nov 5;112(5):1189-96. doi: 10.1378/chest.112.5.1189.

  PMID: 9367456 RESULT

• Bennett-Guerrero E, Ayuso L, Hamilton-Davies C, White WD, Barclay GR, Smith PK, King SA, Muhlbaier LH, Newman MF, Mythen MG. Relationship of preoperative antiendotoxin core antibodies and adverse outcomes following cardiac surgery. JAMA. 1997 Feb 26;277(8):646-50.

  PMID: 9039883 RESULT

• Hamilton-Davies C, Barclay GR, Murphy WG, Machin SJ, Webb AR. Passive immunisation with IgG endotoxin core antibody hyperimmune fresh frozen plasma. Vox Sang. 1996;71(3):165-9. doi: 10.1046/j.1423-0410.1996.7130165.x.

  PMID: 8912459 RESULT

• Poland GA, Ovsyannikova IG, Jacobson RM. Vaccine immunogenetics: bedside to bench to population. Vaccine. 2008 Nov 18;26(49):6183-8. doi: 10.1016/j.vaccine.2008.06.057. Epub 2008 Jul 1.

  PMID: 18598732 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum Plasma PaxGene for genetic sequencing Monocytes

MeSH Terms

Conditions

Aortic Valve Disease; Immune System Diseases; Sepsis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Chris Thiemermann

  Queen Mary University London

  STUDY DIRECTOR

Central Study Contacts

Colin Hamilton-Davies, MBBS MD

CONTACT

+44(0)2037658348; colin.hamilton-davies@qmul.ac.uk

Robert Smith, MBBS FRCA

CONTACT

+44(0)2037658348; andrew.smith@qmul.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 16, 2020
• Study Start: September 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

GB (1)