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Cardiac and Renal Biomarkers in Arthroplasty Surgery

Primary Purpose

Renal Injury, Anesthesia, Myocardial Injury

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Spinal Anesthesia
General Anesthetics
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Injury

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Knee Arthroplasty

Hip Arthroplasty

Arm Description

Surgery to replace the knee joint with prothetic joint

Surgery to replace the hip joint with prothetic joint

Outcomes

Primary Outcome Measures

Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively
Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit
Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively
Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension
Pain score assessment using the visual analog score
Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension
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
Pain medication consumption measured in mg
Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension
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
Pain score assessment using the visual analog score
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
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
Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension
Pain medication consumption measured in mg
Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension
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
Pain score assessment using the visual analog score
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
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
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

Full Information

First Posted
April 3, 2019
Last Updated
February 2, 2021
Sponsor
Washington University School of Medicine
Collaborators
Abbott, BioMérieux
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1. Study Identification

Unique Protocol Identification Number
NCT03940651
Brief Title
Cardiac and Renal Biomarkers in Arthroplasty Surgery
Official Title
Effect of Spinal Versus General Anesthesia on Cardiac and Renal Biomarker Levels in Hip and Knee Arthroplasty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Funding ended
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
September 23, 2020 (Actual)
Study Completion Date
September 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Abbott, BioMérieux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Injury, Anesthesia, Myocardial Injury, Arthropathy of Knee, Arthropathy of Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knee Arthroplasty
Arm Type
Experimental
Arm Description
Surgery to replace the knee joint with prothetic joint
Arm Title
Hip Arthroplasty
Arm Type
Experimental
Arm Description
Surgery to replace the hip joint with prothetic joint
Intervention Type
Drug
Intervention Name(s)
Spinal Anesthesia
Intervention Description
Patients will be randomized to type of anesthesia
Intervention Type
Drug
Intervention Name(s)
General Anesthetics
Intervention Description
Patients will be randomized to type of anesthesia
Primary Outcome Measure Information:
Title
Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively
Description
Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit
Time Frame
Before discharge (approximately 24 hours after surgery)
Title
Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively
Description
Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Title
Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population
Description
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Time Frame
Before discharge (approximately 24 hours after surgery)
Title
Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population
Description
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Title
Investigate the effect of spinal anesthesia on biomarker levels in knee arthroplasty population
Description
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Title
Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population
Description
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Time Frame
Before discharge (approximately 24 hours after surgery)
Title
Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population
Description
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Title
Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population
Description
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Time Frame
Before discharge (approximately 24 hours after surgery)
Title
Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population
Description
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Title
Incidence of postoperative renal injury using investigational renal biomarkers
Description
MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml
Time Frame
Before discharge (approximately 24 hours after surgery)
Title
Incidence of postoperative renal injury using investigational renal biomarkers
Description
MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Secondary Outcome Measure Information:
Title
Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension
Description
Pain score assessment using the visual analog score
Time Frame
before discharge
Title
Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension
Description
Pain score assessment using the visual analog score
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Title
Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension
Description
Pain medication consumption measured in mg
Time Frame
before discharge
Title
Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension
Description
Pain medication consumption measured in mg
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Title
Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension
Description
Pain score assessment using the visual analog score
Time Frame
before discharge and at time of postoperative visit (around 2 weeks post discharge)
Title
Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension
Description
Pain score assessment using the visual analog score
Time Frame
before discharge
Title
Difference in cardiac biomarker levels according to surgical groups - Pain scores and the incidence of intraoperative hypotension
Description
Pain score assessment using the visual analog score
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Title
Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension
Description
Pain medication consumption measured in mg
Time Frame
before discharge
Title
Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension
Description
Pain medication consumption measured in mg
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Title
The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension
Description
Pain score assessment using the visual analog score
Time Frame
before discharge
Title
The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension
Description
Pain score assessment using the visual analog score
Time Frame
at time of postoperative visit (around 2 weeks post discharge)
Title
The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension
Description
Pain medication consumption measured in mg
Time Frame
before discharge
Title
The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension
Description
Pain medication consumption measured in mg
Time Frame
at time of postoperative visit (around 2 weeks post discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Helwani, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17403800
Citation
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.
Results Reference
background
PubMed Identifier
23011713
Citation
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.
Results Reference
background
PubMed Identifier
25029449
Citation
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.
Results Reference
background

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Cardiac and Renal Biomarkers in Arthroplasty Surgery

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