Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Hip; Kidney Diseases; Bone Cement Implantation Syndrome; Cardiovascular Diseases

• 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.

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-19
• Study Start: 2024-03-20
• Study First Posted: 2024-03-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2026-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 postoperatively
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)
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
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
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
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
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

Trial Locations

Locations (1)

University of Tartu; 🇪🇪 Tartu, Tartumaa, Estonia