Hematologic Ratios in Postoperative Acute Kidney Injury
Stopped: No charts were reviewed. This study never started.
United States0Started 2018-07-01
Plain-language summary
Acute kidney injury (AKI) is a common complication after surgery for congenital heart disease and is associated with significant morbidity and mortality. To-date, no biomarker has been universally implemented for predicting AKI in neonates after cardiac surgery. In this study, the use of hematological ratios will be evaluated for predicting AKI and postoperative outcomes in this patient cohort.
Who can participate
Age range
0 Days – 31 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease.
Exclusion Criteria:
* Patients with missing relevant preoperative or postoperative data points
* Patients with previous palliation or reoperation,
* Thymus hypo/aplasia (DiGeorge Syndrome, Ataxia-telangiectasia, or Nezelof syndrome),
* Primary immunodeficiency,
* Episode of cardiac arrest within 1 week before surgery,
* Signs or history of preoperative renal impairment or AKI (KDIGO Stage ≥1 observed on preoperative labs),
* Hypothyroidism,
* Patients with a history of infection within a week prior to surgery or antibiotics administered within the first 3 days after surgery (except for postoperative antibiotics).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute Kidney Injury (AKI)
Timeframe: up to 72 hours postoperative
Trial details
NCT IDNCT03658148
SponsorChildren's Hospital Medical Center, Cincinnati