Cardiac and Renal Biomarkers in Arthroplasty Surgery

Phase 4

Terminated

• Conditions: Renal Injury; Myocardial Injury; Arthropathy of Knee; Arthropathy of Hip; Anesthesia
• Interventions: Drug: Spinal Anesthesia; Drug: General Anesthetics

• Registration Number: NCT03940651
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The investigators will compare the effect of spinal anesthesia to general anesthesia on the level of high sensitivity cardiac biomarkers in patients undergoing hip or knee arthroplasty. The investigators will also measure renal biomarkers in urine to evaluate kidney injury in the postoperative period.

Detailed Description

The study will enroll a total of 140 adult patients undergoing hip or knee arthroplasty (equal numbers) at Barnes-Jewish-Hospital. These procedures will be randomized with 50% of the procedures performed under spinal anesthesia and 50% procedures performed under general anesthesia.

Patients randomized to spinal anesthesia will receive sedation with dexmedetomidine up to 1 mcg/kg/min, and then add small dose of propofol (up to 50 mcg/kg/min) and fentanyl at the discretion of the anesthesia provider the Richmond Agitation and Sedation Scale (RASS) -2 to -3. Headphones to play music will be offered to patients undergoing spinal anesthesia to minimize the noise generated from the surgical intervention.

The investigators will study the effect of spinal anesthesia versus general anesthesia on cardiac biomarker levels in hip and knee arthroplasty population (levels of Hs-cTnI postoperatively compared to baseline values) Also, the incidence of postoperative renal injury using investigational renal biomarkers, Myo-Inositol Oxygenase (MIOX) and Nephrocheck

Study Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-07
• Study Start: 2019-09-04
• Primary Completion: 2020-09-23
• Study Completion: 2020-09-23
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Adult patients, age 60 years or older
• Ability to provide informed consent
• American Society of Anesthesiologists (ASA) classification II or higher

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Exclusion Criteria

• Hip fracture procedures
• Contraindications to neuraxial anesthesia per The American Society of Regional Anesthesia (ASRA) guidelines
• Procedure anticipated duration is longer than expected planned spinal anesthesia duration

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hip Arthroplasty	General Anesthetics	Surgery to replace the hip joint with prothetic joint
Hip Arthroplasty	Spinal Anesthesia	Surgery to replace the hip joint with prothetic joint
Knee Arthroplasty	Spinal Anesthesia	Surgery to replace the knee joint with prothetic joint
Knee Arthroplasty	General Anesthetics	Surgery to replace the knee joint with prothetic joint

Primary Outcome Measures

Name	Time	Method
Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population	at time of postoperative visit (around 2 weeks post discharge)	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively	at time of postoperative visit (around 2 weeks post discharge)	Hs-cTnI increase \>50% above the sex-specific 99th percentile upper reference limit
Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population	at time of postoperative visit (around 2 weeks post discharge)	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Incidence of postoperative renal injury using investigational renal biomarkers	at time of postoperative visit (around 2 weeks post discharge)	MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml
Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population	at time of postoperative visit (around 2 weeks post discharge)	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Investigate the effect of spinal anesthesia on biomarker levels in knee arthroplasty population	at time of postoperative visit (around 2 weeks post discharge)	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values

Secondary Outcome Measures

Name	Time	Method
Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension	at time of postoperative visit (around 2 weeks post discharge)	Pain score assessment using the visual analog score
Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension	at time of postoperative visit (around 2 weeks post discharge)	Pain medication consumption measured in mg
Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension	before discharge	Pain score assessment using the visual analog score
The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension	at time of postoperative visit (around 2 weeks post discharge)	Pain medication consumption measured in mg
Difference in cardiac biomarker levels according to surgical groups - Pain scores and the incidence of intraoperative hypotension	at time of postoperative visit (around 2 weeks post discharge)	Pain score assessment using the visual analog score
Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension	at time of postoperative visit (around 2 weeks post discharge)	Pain medication consumption measured in mg
The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension	at time of postoperative visit (around 2 weeks post discharge)	Pain score assessment using the visual analog score

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States