Bone Cement Implantation Syndrome, Cardiovascular Diseases, Kidney Diseases, Osteoarthritis, Hip
Conditions
Brief summary
Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Bone cement implantation syndrome is associated with cemented hip arthroplasty and it has been shown to increase cardiovascular and renal complication and brain damage postoperatively. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients.
Detailed description
Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Cemented hip arthroplasty is strongly associated with bone cement implantation syndrome (BCIS). It is characterized by hypoxia, hypotension and/or unexpected loss of consciousness occurring around the time of cementation, prosthesis insertion or reduction of the joint. It has been shown to increase cardiovascular and renal complication and brain damage postoperatively. Remote-ischemic preconditioning has shown kidney, myocardial and brain injury protective effect on non-cardiac surgery patients. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients.
Interventions
PROCEDURERemote Ischemic Preconditioning
4 cycles of 5 min pressure (produces an ischemia episode in subject's upper limb) with AutoRIC device (Starfish Medical, Canada)
OTHERSHAM
4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure
Sponsors
University of Tartu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization and intervention is done by a dedicated study nurse. Patient, orthopedic surgeon, investigator and outcomes assessor and statistician are all blinded to the study intervention.
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* age \>65 years * undergoing total hip cemented hip arthroplasty
Exclusion criteria
* previously diagnosed peripheral artery disease on both upper limb * RIPC is contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial injury | From enrollment to 3. postoperative day | Peak hs-cTnT value * baseline characteristics are measured before surgery * measuring is repeated 1h after surgery and up to 3 days postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical serious complications | From enrollment to 1 year postoperatively | Mortality, Bone cement implantation syndrome, serious cardiovascular complications (heart attack, heart failure, stroke, arrhythmia, peripheral artery thrombosis) * data is collected trough Estonian National Health database Digilugu * blood pressure, saturation and patient's mental state are monitored during the operation to register any case of bone cement implantation syndrome |
| Carotid-femoral pulse velocity | From enrollment to 1. postoperative day | Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery |
| Augmentation index | From enrollment to 1. postoperative day | Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery |
| Brain injury | From enrollment to 3. postoperative day | Change in baseline of S-100B and NSE * baseline characteristics are measured before surgery * measuring is repeated 1h after surgery and up to 3 days postoperatively Change in baseline of Choice-reaction test results done pre-and postoperatively * baseline test result is measured before surgery * measuring is repeated 24h after surgery |
| Cardiovascular injury | From enrollment to 3. postoperative day | Change in baseline of hs-cTnT and NT-proBNP * baseline characteristics are measured before surgery * measurements are repeated 1h after surgery and up to 3 days postoperatively (once a day) |
| Total antioxidative capacity (TAC) | From enrollment to 3. postoperative day | Change in baseline of total antioxidant capacity (TAC) * baseline characteristics are measured before surgery * measuring is repeated 1h after surgery and up to 3 days postoperatively |
| Oxidative stress level (total peroxide levels) | From enrollment to 3. postoperative day | Change in baseline total peroxide levels (TPX) * baseline characteristics are measured before surgery * measuring is repeated 1h after surgery and up to 3 days postoperatively |
| Inflammation level | From enrollment to 3. postoperative day | Change in baseline of inflammation markers (HIF1α, IL6, IL-1β, TNF-α, IL-10) * baseline characteristics are measured before surgery * measuring is repeated 1h after surgery and on the first postoperative day |
| Low molecular weight metabolites (uM) | From enrollment to 1. postoperative day | Change in baseline of: Acylcarnitines Phosphatidylcholines Lysophosphatidylcholines Sphingomyelins Ceramides Dihydroceramides Hexosylceramides Dihexosylceramides Trihexosylceramides Cholesteryl esters Diglycerides Triglycerides Amino acids Amino acid related Bile acids Biogenic amines Carboxylic acids Fatty acids Hormones Indoles and derivatives |
| Kidney Injury | From enrollment to 3. postoperative day | Change in baseline of creatinine and cystatin C * baseline characteristics are measured before surgery * measuring is repeated 1h after surgery and up to 3 days postoperatively |
Countries
Estonia
Contacts
Primary ContactKaspar Tootsi, PhD
Backup ContactKaarel Ernits, MD
Outcome results
None listed