Hematologic Ratios in Postoperative Acute Kidney Injury

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03658148

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Procedure: Cardiac Surgery with Cardiopulmonary Bypass

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2018

Actual Primary Completion Date :

Nov 1, 2020

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Study Group Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease (CHD) between 2008-2017.	Procedure: Cardiac Surgery with Cardiopulmonary Bypass Cardiac Surgery with Cardiopulmonary Bypass

Arm

Intervention/Treatment

Study Group

Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease (CHD) between 2008-2017.

Procedure: Cardiac Surgery with Cardiopulmonary Bypass

Cardiac Surgery with Cardiopulmonary Bypass

Outcome Measures

Primary Outcome Measures

Acute Kidney Injury (AKI) [up to 72 hours postoperative]
Occurrence of AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification (using serum creatinine)

Secondary Outcome Measures

Operative Mortality [up to 30 days postoperative]
Mortality within 30 days after surgery (rate)
1-year mortality [up to 1 year postoperative]
Mortality within 1 year after surgery (rate)
Length of hospital stay [up to 1 year postoperative]
Total length of hospital stay (days)
Length of Cardiac Intensive Care Unit (CICU) Stay [up to 1 year postoperative]
Total length of stay in the CICU (days)
Length of mechanical ventilation [up to 1 year postoperative]
Total length of postoperative mechanical ventilator support (days)
Vasoactive infusion-free days [up to 28 days postoperative]
(days)
Postoperative infection [up to 3 days postoperative]
Occurrence 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 Syndrome [up to 2 days postoperative]
Occurrence of Low Cardiac Output Syndrome defined as any of the following at any time during the first 48 hours postoperative: Lactate >6mmol/l and mixed venous saturation (ScvO2) <60% (or SaO2-ScvO2 difference greater than 35% in a single ventricle), Vasoactive inotropic score (VIS)3 ≥ 10, Extracorporeal Membrane Oxygenation (ECMO

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 31 Days

Sexes Eligible for Study:

All

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).