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Hematologic Ratios in Postoperative Acute Kidney Injury

Association Between Hematological Ratios and Acute Kidney Injury After Cardiovascular Surgery in Neonates: a Retrospective Observational Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03658148
Enrollment
0
Registered
2018-09-05
Start date
2018-07-01
Completion date
2021-06-01
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury, Cardiac Surgery, Cardiopulmonary Bypass, Congenital Heart Disease, Biomarkers

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.

Interventions

PROCEDURECardiac Surgery with Cardiopulmonary Bypass

Cardiac Surgery with Cardiopulmonary Bypass

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 31 Days
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Acute Kidney Injury (AKI)up to 72 hours postoperativeOccurrence of AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification (using serum creatinine)

Secondary

MeasureTime frameDescription
1-year mortalityup to 1 year postoperativeMortality within 1 year after surgery (rate)
Length of hospital stayup to 1 year postoperativeTotal length of hospital stay (days)
Length of Cardiac Intensive Care Unit (CICU) Stayup to 1 year postoperativeTotal length of stay in the CICU (days)
Operative Mortalityup to 30 days postoperativeMortality within 30 days after surgery (rate)
Vasoactive infusion-free daysup to 28 days postoperative(days)
Postoperative infectionup to 3 days postoperativeOccurrence of infection defined as: antibiotic use (other than perioperative) within 3 days postop, positive blood culture within 3 days postop, positive viral panel within 3 days postop
Low Cardiac Output Syndromeup to 2 days postoperativeOccurrence of Low Cardiac Output Syndrome defined as any of the following at any time during the first 48 hours postoperative: 1. Lactate \>6mmol/l and mixed venous saturation (ScvO2) \<60% (or SaO2-ScvO2 difference greater than 35% in a single ventricle), 2. Vasoactive inotropic score (VIS)3 ≥ 10, 3. Extracorporeal Membrane Oxygenation (ECMO
Length of mechanical ventilationup to 1 year postoperativeTotal length of postoperative mechanical ventilator support (days)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026