Hematologic Ratios in Postoperative Acute Kidney Injury

Withdrawn

• Conditions: Acute Kidney Injury
• Interventions: Procedure: Cardiac Surgery with Cardiopulmonary Bypass

• Registration Number: NCT03658148
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-05
• Primary Completion: 2020-11-01
• Status Verified: 2021-06
• Study Completion: 2021-06-01
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Operative Mortality	up to 30 days postoperative	Mortality within 30 days after surgery (rate)
Length of Cardiac Intensive Care Unit (CICU) Stay	up to 1 year postoperative	Total length of stay in the CICU (days)
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: 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
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)
Vasoactive infusion-free days	up to 28 days postoperative	(days)
Length of mechanical ventilation	up to 1 year postoperative	Total length of postoperative mechanical ventilator support (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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States