Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.
- Conditions
- Osteoarthritis, HipKidney DiseasesBone Cement Implantation SyndromeCardiovascular Diseases
- Interventions
- Other: SHAMProcedure: Remote Ischemic Preconditioning
- Registration Number
- NCT06323018
- Lead Sponsor
- University of Tartu
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- age >65 years
- undergoing total hip cemented hip arthroplasty
- previously diagnosed peripheral artery disease on both upper limb
- RIPC is contraindicated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group SHAM SHAM procedure is done one hour before cemented hip arthroplasty and comprises of 4 cycles of 5min sham procedure. Everything apart from the pressure in the cuff is similar to the RIPC procedure. Remote Ischemic preconditioning group Remote Ischemic Preconditioning RIPC procedure is done one hour before cemented hip arthroplasty and comprises of 4 ischemia (using brachial cuff with suprasystolic blood pressure for 5 min) and reperfusion (5 min) cycles.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 postoperativelyCardiovascular 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)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 postoperativelyClinical 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 syndromeCarotid-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 surgeryOxidative 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 postoperativelyAugmentation index From enrollment to 1. postoperative day Measured with Sphygmocor XCEL
* baseline characteristics are measured before surgery
* measuring is repeated 24 h after surgeryBrain 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 surgeryInflammation 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 dayLow 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
Trial Locations
- Locations (1)
University of Tartu
🇪🇪Tartu, Tartumaa, Estonia