Clinical trial NCT03658148: Hematologic Ratios in Postoperative Acute Kidney Injury
Official title: Association Between Hematological Ratios and Acute Kidney Injury After Cardiovascular Surgery in Neonates: a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
Cardiac Surgery
Cardiopulmonary Bypass
Congenital Heart Disease
Biomarkers
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease between 2008-2017.

Brief 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.

Detailed description: In adults, hematological ratios which can be calculated from a routinely ordered complete blood count with differential, such as the neutrophil/lymphocyte ratio, have been demonstrated to be correlated with acute kidney injury (AKI) and other clinical outcomes after cardiovascular surgery. In this retrospective observational study, the association between hematological ratios (neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, neutrophil/lymphocyte\*platelet ratio, monocyte/lymphocyte ratio, and plateletcrit) and postoperative AKI, morbidity (length of ICU stay, hospital stay, mechanical ventilation, vasoactive infusion-free days, etc.) and mortality will be evaluated in neonates who underwent cardiac surgery with cardiopulmonary bypass.

Eligibility criteria: 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).

Primary outcomes:
measure: Acute Kidney Injury (AKI)
timeFrame: up to 72 hours postoperative
Secondary outcomes:
measure: Operative Mortality
timeFrame: up to 30 days postoperative
measure: 1-year mortality
timeFrame: up to 1 year postoperative
measure: Length of hospital stay
timeFrame: up to 1 year postoperative
measure: Length of Cardiac Intensive Care Unit (CICU) Stay
timeFrame: up to 1 year postoperative
measure: Length of mechanical ventilation
timeFrame: up to 1 year postoperative
measure: Vasoactive infusion-free days
timeFrame: up to 28 days postoperative
measure: Postoperative infection
timeFrame: up to 3 days postoperative
measure: Low Cardiac Output Syndrome
timeFrame: up to 2 days postoperative
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References: