Hematologic Ratios in Postoperative Acute Kidney Injury

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Kidney Injury
• Intervention / Treatment: 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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 month (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Kidney Injury (AKI)	Occurrence of AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification (using serum creatinine)	up to 72 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Mortality	Mortality within 30 days after surgery (rate)	up to 30 days postoperative
1-year mortality	Mortality within 1 year after surgery (rate)	up to 1 year postoperative
Length of hospital stay	Total length of hospital stay (days)	up to 1 year postoperative
Length of Cardiac Intensive Care Unit (CICU) Stay	Total length of stay in the CICU (days)	up to 1 year postoperative
Length of mechanical ventilation	Total length of postoperative mechanical ventilator support (days)	up to 1 year postoperative
Vasoactive infusion-free days	(days)	up to 28 days postoperative
Postoperative infection	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	up to 3 days postoperative
Low Cardiac Output Syndrome	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	up to 2 days postoperative

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Cardiac Surgery; Biomarkers; Cardiopulmonary Bypass; Acute Kidney Injury
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: CIN001-AKI Hematologic Ratios

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No