NCT03940651

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 4, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2020

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

April 3, 2019

Last Update Submit

February 2, 2021

Conditions

Renal InjuryAnesthesiaMyocardial InjuryArthropathy of KneeArthropathy of Hip

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (13)

  • Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension

    before discharge

  • 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)

  • Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension

    before discharge

  • 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)

  • Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension

    before discharge and at time of postoperative visit (around 2 weeks post discharge)

  • +8 more secondary outcomes

Study Arms (2)

Knee Arthroplasty

EXPERIMENTAL

Surgery to replace the knee joint with prothetic joint

Drug: Spinal AnesthesiaDrug: General Anesthetics

Hip Arthroplasty

EXPERIMENTAL

Surgery to replace the hip joint with prothetic joint

Drug: Spinal AnesthesiaDrug: General Anesthetics

Interventions

Spinal AnesthesiaDRUG

Patients will be randomized to type of anesthesia

Hip ArthroplastyKnee Arthroplasty
General AnestheticsDRUG

Patients will be randomized to type of anesthesia

Hip ArthroplastyKnee Arthroplasty

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • 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.

    PMID: 17403800BACKGROUND

  • 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.

    PMID: 23011713BACKGROUND

  • 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.

    PMID: 25029449BACKGROUND

MeSH Terms

Interventions

Anesthesia, SpinalAnesthetics, General

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Mohammad Helwani, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

May 7, 2019

Study Start

September 4, 2019

Primary Completion

September 23, 2020

Study Completion

September 23, 2020

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)