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GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635606
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : May 4, 2022
Sponsor:
Collaborators:
WakeMed Health and Hospitals
Johns Hopkins University
Information provided by (Responsible Party):
Sapere Bio

Brief 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. 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.


Condition or disease
Coronary Artery Disease

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Study Type : Observational
Estimated Enrollment : 592 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of AKI-Sapere Model to Predict Patients at Risk for AKI After Cardiac Surgery: GUARD-AKI (GUiding Against Reserve Decline)
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Development of 30-day persistent kidney impairment (sCr increase of ≥0.5 mg/dL from baseline at the 30-day follow-up visit) [ Time Frame: 30 days post-surgery ]
  3. Development of worsening renal function (a 25% reduction in eGFR at the 30-day follow-up visit) [ Time Frame: 30 days post-surgery ]
  4. 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 ]
  5. 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 ]
  6. Development of the combination of MAKE30 and MACE30 (major adverse reno-cardiovascular events [MARCE30]) [ Time Frame: 30 days post-surgery ]

Biospecimen Retention:   Samples With DNA
whole blood, plasma, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All subjects entered into this study will be patients at the participating institutions.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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%)
  • 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)

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): NCT03635606


Contacts
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Contact: Lena Randhawa, PhD 919-886-4553 lena.randhawa@sapere-bio.com
Contact: Natalia Mitin, PhD natalia.mitin@sapere-bio.com

Locations
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United States, California
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Contact: Terry Taylor       Terry.Taylor@hoag.org   
Principal Investigator: Asad Shah, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Michelle Parish       maparish@jhmi.edu   
Principal Investigator: Aliaksei Pustavoitau, MD         
United States, North Carolina
WakeMed Health and Hospitals Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Rhonda Norton       rnorton@wakemed.org   
Principal Investigator: Judson Williams, MD         
Sponsors and Collaborators
Sapere Bio
WakeMed Health and Hospitals
Johns Hopkins University
Investigators
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Principal Investigator: Natalia Mitin, PhD Sapere Bio
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Responsible Party: Sapere Bio
ClinicalTrials.gov Identifier: NCT03635606    
Other Study ID Numbers: HSDX-1801
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: May 2022
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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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases