Renal InjuryPhase 4NCT03940651
Cardiac and Renal Biomarkers in Arthroplasty Surgery
A Phase 4 study testing Spinal Anesthesia and General Anesthetics in people with Renal Injury and Anesthesia, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Renal Injury, Anesthesia, Myocardial Injury
- What is being tested?
- Spinal Anesthesia and General Anesthetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2019to 23 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, age 60 years or older
- Ability to provide informed consent
- American Society of Anesthesiologists (ASA) classification II or higher
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Spinal Anesthesia, General Anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal AnesthesiaDrug
Patients will be randomized to type of anesthesia
General AnestheticsDrug
Patients will be randomized to type of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Knee Arthroplasty | Experimental | Surgery to replace the knee joint with prothetic joint Receives: Drug: Spinal Anesthesia; Drug: General Anesthetics |
| Hip Arthroplasty | Experimental | Surgery to replace the hip joint with prothetic joint Receives: Drug: Spinal Anesthesia; Drug: General Anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively
Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Pain score assessment using the visual analog score
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at time of postoperative visit (around 2 weeks post discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start4 Sep 2019
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, BioMérieux
- Responsible party
- Sponsor
- Investigators
- Mohammad Helwani, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940651
- Sponsor's protocol ID
- 201812100
- Status last verified
- Feb 2021
- First submitted
- 3 Apr 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17403800Cram 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.
PubMed 23011713Khan 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.
PubMed 25029449
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spinal Versus General Anesthesia on Cardiac and Renal Biomarker Levels in Hip and Knee Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT03940651
- Acronym / sponsor ID
- 201812100
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Abbott, BioMérieux
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Arthroplasty | Experimental | Drug: Spinal Anesthesia, Drug: General AnestheticsSurgery to replace the knee joint with prothetic joint |
| Hip Arthroplasty | Experimental | Drug: Spinal Anesthesia, Drug: General AnestheticsSurgery to replace the hip joint with prothetic joint |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients, age 60 years or older
- Ability to provide informed consent
- American Society of Anesthesiologists (ASA) classification II or higher
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal AnesthesiaPatients will be randomized to type of anesthesia | Drug | Hip Arthroplasty, Knee Arthroplasty |
| General AnestheticsPatients will be randomized to type of anesthesia | Drug | Hip Arthroplasty, Knee Arthroplasty |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
13 secondary outcomes
Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension
Time frame: before discharge
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)
Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension
Time frame: before discharge
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)
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)
Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension
Time frame: before discharge
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)
Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension
Time frame: before discharge
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)
The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension
Time frame: before discharge
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)
The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension
Time frame: before discharge
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)
Results and safety
The study was stopped early (reason given: Funding ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Background: PubMed 17403800Kurtz 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.
- Background: PubMed 23011713Cram 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.
- Background: PubMed 25029449Khan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Helwani, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal Anesthesia and General Anesthetics in people with Renal Injury and Anesthesia, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively (time frame: Before discharge (approximately 24 hours after surgery)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940651, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.