NCT02496234

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 measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CSA-AKI post surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

July 8, 2015

Last Update Submit

November 22, 2016

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Bypass Graft SurgeryAcute kidney injuryRenal failureBiomarker

Outcome Measures

Primary Outcomes (1)

  • Development of stage 1 or higher postoperative AKI as defined by the AKIN classification (stage 1- ≥ 0.5 mg/dL absolute or ≥ 50% relative rise in peak SCr over the baseline)

    48-72 hours

Secondary Outcomes (13)

  • Number of Participants who suffered postoperative stroke

    30 days

  • Number of Participants who suffered cognitive decline

    30 days

  • Number of Participants requiring prolonged mechanical ventilation (for longer than 24h)

    30 days

  • Number of Participants with : cardiac arrest, perioperative myocardial infarction and perioperative ventricular dysfunction.

    30 days

  • Number of Participants with cardiac arrest

    30 days

  • +8 more secondary outcomes

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All subjects entered into this study will be patients of the Duke University Health System.

You may qualify if:

  • Patients must fulfill all criteria to be eligible for this study:
  • Adult patients (\>18 yo) undergoing non-emergency cardiac surgery using cardiopulmonary bypass (CABG, combined CABG/valve, or valve surgery).

You may not qualify if:

  • Patients who fulfill any of the following criteria will be excluded:
  • Emergency surgery.
  • Off-pump coronary bypass grafting.
  • Aortic aneurysm repair.
  • Congenital heart disease repair.
  • Heart transplant or LVAD patient.
  • Severe heart failure (LVEF\<25%).
  • Hemodynamic instability or requiring preoperative vasopressors or IABP.
  • Pre-existing end-stage kidney disease (eGFR\< 15 mL/min/1.73 m2) or renal transplantation.
  • Presence of major active infection (chronic or acute, e.g. sepsis, HIV, pneumonia).
  • Chronic liver disease /cirrhosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

White blood cells Plasma

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Kidney InjuryRenal Insufficiency

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Mihai V Podgoreanu, MD, FASE

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 14, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

US(1)