Hematologic Ratios in Postoperative Acute Kidney Injury

NCT03658148 | Withdrawn

• 1 other identifier: CIN001-AKI Hematologic Ratios
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Operative Mortality

  up to 30 days postoperative

• 1-year mortality

  up to 1 year postoperative

• Length of hospital stay

  up to 1 year postoperative

• Length of Cardiac Intensive Care Unit (CICU) Stay

  up to 1 year postoperative

• Length of mechanical ventilation

  up to 1 year postoperative

Study Arms (1)

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

Interventions

Cardiac Surgery with Cardiopulmonary Bypass PROCEDURE

Cardiac Surgery with Cardiopulmonary Bypass

Study Group

Eligibility Criteria

• Age: 0 Days - 31 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Heart Defects, Congenital

Interventions

Cardiac Surgical Procedures; Cardiopulmonary Bypass

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Extracorporeal Circulation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: September 5, 2018
• Study Start: July 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: June 1, 2021
• Last Updated: November 6, 2024

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)