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Cardiac and Renal Biomarkers in Arthroplasty Surgery

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ClinicalTrials.gov Identifier: NCT03940651
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.)
First Posted : May 7, 2019
Last Update Posted : May 7, 2020
Sponsor:
Collaborators:
Abbott
BioMérieux
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Renal Injury Anesthesia Myocardial Injury Arthropathy of Knee Arthropathy of Hip Drug: Spinal Anesthesia Drug: General Anesthetics Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Spinal Versus General Anesthesia on Cardiac and Renal Biomarker Levels in Hip and Knee Arthroplasty Surgery
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

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




Primary Outcome Measures :
  1. Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively [ Time Frame: Before discharge (approximately 24 hours after surgery) ]
    Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit

  2. Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively [ Time Frame: at time of postoperative visit (around 2 weeks post discharge) ]
    Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit

  3. Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population [ Time Frame: Before discharge (approximately 24 hours after surgery) ]
    cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values

  4. Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population [ Time Frame: 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

  5. Investigate the effect of spinal anesthesia on biomarker levels in knee arthroplasty population [ Time Frame: 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

  6. Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population [ Time Frame: Before discharge (approximately 24 hours after surgery) ]
    cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values

  7. Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population [ Time Frame: 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

  8. Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population [ Time Frame: Before discharge (approximately 24 hours after surgery) ]
    cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values

  9. Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population [ Time Frame: 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

  10. Incidence of postoperative renal injury using investigational renal biomarkers [ Time Frame: Before discharge (approximately 24 hours after surgery) ]
    MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml

  11. Incidence of postoperative renal injury using investigational renal biomarkers [ Time Frame: 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


Secondary Outcome Measures :
  1. Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension [ Time Frame: before discharge ]
    Pain score assessment using the visual analog score

  2. Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension [ Time Frame: at time of postoperative visit (around 2 weeks post discharge) ]
    Pain score assessment using the visual analog score

  3. Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension [ Time Frame: before discharge ]
    Pain medication consumption measured in mg

  4. Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension [ Time Frame: at time of postoperative visit (around 2 weeks post discharge) ]
    Pain medication consumption measured in mg

  5. Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension [ Time Frame: before discharge and at time of postoperative visit (around 2 weeks post discharge) ]
    Pain score assessment using the visual analog score

  6. Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension [ Time Frame: before discharge ]
    Pain score assessment using the visual analog score

  7. Difference in cardiac biomarker levels according to surgical groups - Pain scores and the incidence of intraoperative hypotension [ Time Frame: at time of postoperative visit (around 2 weeks post discharge) ]
    Pain score assessment using the visual analog score

  8. Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension [ Time Frame: before discharge ]
    Pain medication consumption measured in mg

  9. Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension [ Time Frame: at time of postoperative visit (around 2 weeks post discharge) ]
    Pain medication consumption measured in mg

  10. The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension [ Time Frame: before discharge ]
    Pain score assessment using the visual analog score

  11. The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension [ Time Frame: at time of postoperative visit (around 2 weeks post discharge) ]
    Pain score assessment using the visual analog score

  12. The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension [ Time Frame: before discharge ]
    Pain medication consumption measured in mg

  13. The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension [ Time Frame: at time of postoperative visit (around 2 weeks post discharge) ]
    Pain medication consumption measured in mg



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940651


Locations
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United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Abbott
BioMérieux
Investigators
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Principal Investigator: Mohammad Helwani, MD Washington University School of Medicine
Publications:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03940651    
Other Study ID Numbers: 201812100
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Wounds and Injuries
Musculoskeletal Diseases
Anesthetics
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs