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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
4 cycles of 5 min pressure (produces an ischemia episode in subject's upper limb) with AutoRIC device (Starfish Medical, Canada)
4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure
University of Tartu
Tartu, Tartu, Estonia
RECRUITINGMyocardial injury
Peak hs-cTnT value * baseline characteristics are measured before surgery * measuring is repeated 1h after surgery and up to 3 days postoperatively
Time frame: From enrollment to 3. postoperative day
Cardiovascular injury
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)
Time frame: From enrollment to 3. postoperative day
Clinical serious complications
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
Time frame: From enrollment to 1 year postoperatively
Carotid-femoral pulse velocity
Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery
Time frame: From enrollment to 1. postoperative day
Augmentation index
Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery
Time frame: From enrollment to 1. postoperative day
Brain injury
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
Time frame: From enrollment to 3. postoperative day
Kidney Injury
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
Time frame: From enrollment to 3. postoperative day
Total antioxidative capacity (TAC)
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
Time frame: From enrollment to 3. postoperative day
Oxidative stress level (total peroxide levels)
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
Time frame: From enrollment to 3. postoperative day
Inflammation level
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
Time frame: From enrollment to 3. postoperative day
Low molecular weight metabolites (uM)
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
Time frame: From enrollment to 1. postoperative day
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