Cardiac and Renal Biomarkers in Arthroplasty Surgery

Effect of Spinal Versus General Anesthesia on Cardiac and Renal Biomarker Levels in Hip and Knee Arthroplasty Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Myocardial Injury; Anesthesia; Arthropathy of Knee; Arthropathy of Hip; Renal Injury
• Intervention / Treatment: Drug: Spinal Anesthesia; Drug: General Anesthetics

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Knee Arthroplasty; Surgery to replace the knee joint with prothetic joint	Drug: Spinal Anesthesia; Patients will be randomized to type of anesthesia; Drug: General Anesthetics; Patients will be randomized to type of anesthesia
EXPERIMENTAL: Hip Arthroplasty; Surgery to replace the hip joint with prothetic joint	Drug: Spinal Anesthesia; Patients will be randomized to type of anesthesia; Drug: General Anesthetics; Patients will be randomized to type of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively	Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit	Before discharge (approximately 24 hours after surgery)
Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively	Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit	at time of postoperative visit (around 2 weeks post discharge)
Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values	Before discharge (approximately 24 hours after surgery)
Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values	at time of postoperative visit (around 2 weeks post discharge)
Investigate the effect of spinal anesthesia on biomarker levels in knee arthroplasty population	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values	at time of postoperative visit (around 2 weeks post discharge)
Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values	Before discharge (approximately 24 hours after surgery)
Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values	at time of postoperative visit (around 2 weeks post discharge)
Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values	Before discharge (approximately 24 hours after surgery)
Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population	cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values	at time of postoperative visit (around 2 weeks post discharge)
Incidence of postoperative renal injury using investigational renal biomarkers	MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml	Before discharge (approximately 24 hours after surgery)
Incidence of postoperative renal injury using investigational renal biomarkers	MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml	at time of postoperative visit (around 2 weeks post discharge)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Abbott; BioMérieux
• Investigators: Principal Investigator: Mohammad Helwani, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
• Cram P, Lu X, Kates SL, Singh JA, Li Y, Wolf BR. Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010. JAMA. 2012 Sep 26;308(12):1227-36. doi: 10.1001/2012.jama.11153.
• Khan J, Alonso-Coello P, Devereaux PJ. Myocardial injury after noncardiac surgery. Curr Opin Cardiol. 2014 Jul;29(4):307-11. doi: 10.1097/HCO.0000000000000069.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2019
• Primary Completion (ACTUAL): September 23, 2020
• Study Completion (ACTUAL): September 23, 2020

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (ACTUAL): May 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Anesthetics, General
• Other Study ID Numbers: 201812100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No