Hematologic Ratios in Postoperative Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03658148
• Other study ID #: CIN001-AKI Hematologic Ratios
• Status: Withdrawn
• Start date: July 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2021
• Est. primary completion date: November 1, 2020
• Gender: All
• Age group: N/A to 31 Days

Eligibility

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).

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Procedure:
• Cardiac Surgery with Cardiopulmonary Bypass
Cardiac Surgery with Cardiopulmonary Bypass

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative Mortality	Mortality within 30 days after surgery (rate)	up to 30 days postoperative
Secondary	1-year mortality	Mortality within 1 year after surgery (rate)	up to 1 year postoperative
Secondary	Length of hospital stay	Total length of hospital stay (days)	up to 1 year postoperative
Secondary	Length of Cardiac Intensive Care Unit (CICU) Stay	Total length of stay in the CICU (days)	up to 1 year postoperative
Secondary	Length of mechanical ventilation	Total length of postoperative mechanical ventilator support (days)	up to 1 year postoperative
Secondary	Vasoactive infusion-free days	(days)	up to 28 days postoperative
Secondary	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
Secondary	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