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NCT Number: NCT03635606

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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 (eGFR change of ≥25% from baseline at the 30-day follow-up visit)

    Time frame: 30 days post-surgery

  3. Development of new onset atrial fibrilation

    Time frame: within 7 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

Sponsors and collaborators

Lead sponsor

Sapere Bio

Industry

Collaborators

  • Hoag Memorial Hospital Presbyterian
  • Johns Hopkins University
  • WakeMed Health and Hospitals

Registry information

Official study title

Validation of AKI-Sapere Model to Predict Patients at Risk for AKI After Cardiac Surgery: GUARD-AKI (GUiding Against Reserve Decline)

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 17, 2018
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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