Coronary Artery DiseaseNCT03635606
GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients
An observational study of Coronary Artery Disease, run by Sapere Bio at 3 sites in United States.
Trial summary
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 370 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Feb 2020to 28 Feb 2023
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects entered into this study will be patients at the participating institutions.
Who may be able to join
- Adult patients (>40 years) undergoing non-emergency (urgent or scheduled) cardiac surgery using cardiopulmonary bypass (CABG or combined CABG/valve).
- Patients must be able to understand English and be willing to sign informed consent.
Who cannot join
- Emergency surgery
- Off-pump coronary bypass grafting
- Aortic aneurysm repair
- Congenital heart disease repair
- Heart transplant or left ventricular assist device patient
- Severe heart failure (left ventricular ejection fraction <25%)
Show all 11Show fewer
- Hemodynamic instability or requiring preoperative vasopressors or IABP
- Pre-existing kidney disease (eGFR <30 mL/min/1.73 m2) or renal transplantation.
- Presence of major active infection (chronic or acute, eg, sepsis, HIV, pneumonia)
- Chronic liver disease/cirrhosis
- Participation in an additional trial at the time of surgery or anytime within 30d of surgery where intervention could potentially alter renal health (unless in the control arm)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
WakeMed Health and Hospitals
Raleigh, North Carolina, 27610
About this study
Official title: Validation of AKI-Sapere Model to Predict Patients at Risk for AKI After Cardiac Surgery: GUARD-AKI (GUiding Against Reserve Decline)
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes.
The primary purpose of this study is to validate a panel of biomarkers identified in the discovery study (referred to as AKI-Sapere prognostic) to identify patients at risk for all stages of CSA-AKI.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of stage 1 or higher postoperative AKI as defined by the KDIGO classification (stage 1 = sCr value of ≥0.3 mg/dL in the first 48h or a relative increase of ≥50% in peak sCr from baseline within 7 days post-surgery)
Measured: within 7 days post-surgery
Secondary outcomes (6)
Development of moderate to severe AKI (sCr increase of ≥100% within 7 days post surgery or a sCr increase of ≥100% from baseline within 7 days and urine output <0.5 mL/kg/h for >12h)
Measured: within 7 days post-surgery
Development of 30-day persistent kidney impairment (eGFR change of ≥25% from baseline at the 30-day follow-up visit)
Measured: 30 days post-surgery
Development of new onset atrial fibrilation
Measured: within 7 days post-surgery
Development of 30-day major adverse kidney events (MAKE30): a composite of persistently impaired renal function (sCr increase of ≥0.5 mg/dL from baseline [pre-surgery]), new dialysis, and death
Measured: 30 days post-surgery
Development of 30-day major adverse cardiac events (MACE30): a composite of myocardial infarction (MI), stroke, heart failure, and death
Measured: 30 days post-surgery
Development of the combination of MAKE30 and MACE30 (major adverse reno-cardiovascular events [MARCE30])
Measured: 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start24 Feb 2020
- Primary completion1 Sep 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sapere Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WakeMed Health and Hospitals, Johns Hopkins University, Hoag Memorial Hospital Presbyterian
- Responsible party
- Sponsor
- Investigators
- Natalia Mitin, PhD, Principal investigator, Sapere Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635606
- Sponsor's protocol ID
- HSDX-1801
- Status last verified
- Mar 2023
- First submitted
- 15 Aug 2018
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of AKI-Sapere Model to Predict Patients at Risk for AKI After Cardiac Surgery: GUARD-AKI (GUiding Against Reserve Decline)
- ClinicalTrials.gov ID
- NCT03635606
- Acronym / sponsor ID
- HSDX-1801
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Sapere BioIndustry (pharma, biotech, devices)
- Collaborators
- WakeMed Health and Hospitals, Johns Hopkins University, Hoag Memorial Hospital Presbyterian
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 17 Aug 2018 (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.
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes.
The primary purpose of this study is to validate a panel of biomarkers identified in the discovery study (referred to as AKI-Sapere prognostic) to identify patients at risk for all stages of CSA-AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects entered into this study will be patients at the participating institutions.
Key inclusion criteria (2 listed)
- Adult patients (>40 years) undergoing non-emergency (urgent or scheduled) cardiac surgery using cardiopulmonary bypass (CABG or combined CABG/valve).
- Patients must be able to understand English and be willing to sign informed consent.
Key exclusion criteria (11 listed)
- Emergency surgery
- Off-pump coronary bypass grafting
- Aortic aneurysm repair
- Congenital heart disease repair
- Heart transplant or left ventricular assist device patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of stage 1 or higher postoperative AKI as defined by the KDIGO classification (stage 1 = sCr value of ≥0.3 mg/dL in the first 48h or a relative increase of ≥50% in peak sCr from baseline within 7 days post-surgery)
Time frame: within 7 days post-surgery
6 secondary outcomes
Development of moderate to severe AKI (sCr increase of ≥100% within 7 days post surgery or a sCr increase of ≥100% from baseline within 7 days and urine output <0.5 mL/kg/h for >12h)
Time frame: within 7 days post-surgery
Development of 30-day persistent kidney impairment (eGFR change of ≥25% from baseline at the 30-day follow-up visit)
Time frame: 30 days post-surgery
Development of new onset atrial fibrilation
Time frame: within 7 days post-surgery
Development of 30-day major adverse kidney events (MAKE30): a composite of persistently impaired renal function (sCr increase of ≥0.5 mg/dL from baseline [pre-surgery]), new dialysis, and death
Time frame: 30 days post-surgery
Development of 30-day major adverse cardiac events (MACE30): a composite of myocardial infarction (MI), stroke, heart failure, and death
Time frame: 30 days post-surgery
Development of the combination of MAKE30 and MACE30 (major adverse reno-cardiovascular events [MARCE30])
Time frame: 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- 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.
Natalia Mitin, PhD principal investigator
Sapere Bio
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Sapere Bio at 3 sites 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Development of stage 1 or higher postoperative AKI as defined by the KDIGO classification (stage 1 = sCr value of ≥0.3 mg/dL in the first 48h or a relative increase of ≥50% in peak sCr from baseline within 7 days post-surgery) (time frame: within 7 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2023.