Hematologic Ratios in Postoperative Acute Kidney Injury | NCT03658148

Studies
Hematologic Ratios in Postoperative Acute Kidney Injury

NCT03658148

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Withdrawn

Last Update Posted

Nov 6, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Cardiac Surgery with Cardiopulmonary Bypass

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No charts were reviewed. This study never started.

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Aug 6, 2018

First Submission Date that Met QC Criteria

Aug 31, 2018

First Posted Date

Sep 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2024

Last Update Posted Date

Nov 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Surgery with Cardiopulmonary Bypass	Procedure	Cardiac Surgery with Cardiopulmonary Bypass	Study Group

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

31 Days

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center		Cincinnati	Ohio	45220	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006348	Cardiac Surgical Procedures
D002315	Cardiopulmonary Bypass

Ancestor Terms

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures
D005112	Extracorporeal Circulation

Browse Leaves

Not provided

Browse Branches

Not provided