Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.

Cardiovascular Diseases Clinical Trial

— PRINCIPAL  

Official title:

Effects of Remote Ischaemic Preconditioning in Cemented Total Hip Arthroplasty: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323018
• Other study ID #: 384T-26
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: University of Tartu
• Contact: Kaspar Tootsi, PhD
• Phone: +372 7318282
• Email: kaspar.tootsi[@]kliinikum.ee
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Kidney Diseases
• Osteoarthritis, Hip

Intervention

Procedure:
• Remote Ischemic Preconditioning
4 cycles of 5 min pressure (produces an ischemia episode in subject's upper limb) with AutoRIC device (Starfish Medical, Canada)

Other:
• SHAM
4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure

Locations

Country	Name	City	State
Estonia	University of Tartu	Tartu	Tartumaa

Sponsors (1)

Lead Sponsor	Collaborator
University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial injury	Peak hs-cTnT value; baseline characteristics are measured before surgery; measuring is repeated 1h after surgery and up to 3 days postoperatively	From enrollment to 3. postoperative day
Secondary	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)	From enrollment to 3. postoperative day
Secondary	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	From enrollment to 1 year postoperatively
Secondary	Carotid-femoral pulse velocity	Measured with Sphygmocor XCEL; baseline characteristics are measured before surgery; measuring is repeated 24 h after surgery	From enrollment to 1. postoperative day
Secondary	Augmentation index	Measured with Sphygmocor XCEL; baseline characteristics are measured before surgery; measuring is repeated 24 h after surgery	From enrollment to 1. postoperative day
Secondary	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	From enrollment to 3. postoperative day
Secondary	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	From enrollment to 3. postoperative day
Secondary	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	From enrollment to 3. postoperative day
Secondary	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	From enrollment to 3. postoperative day
Secondary	Inflammation level	Change in baseline of inflammation markers (HIF1a, IL6, IL-1ß, TNF-a, IL-10); baseline characteristics are measured before surgery; measuring is repeated 1h after surgery and on the first postoperative day	From enrollment to 3. postoperative day
Secondary	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	From enrollment to 1. postoperative day