Hematologic Ratios in Postoperative Acute Kidney Injury

NCT ID: NCT03658148

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-06-01

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Study Group

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

Cardiac Surgery with Cardiopulmonary Bypass

Intervention Type PROCEDURE

Cardiac Surgery with Cardiopulmonary Bypass

Interventions

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Cardiac Surgery with Cardiopulmonary Bypass

Cardiac Surgery with Cardiopulmonary Bypass

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

0 Days

Maximum Eligible Age

31 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CIN001-AKI Hematologic Ratios

Identifier Type: -

Identifier Source: org_study_id

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