Acute Kidney Injury After Cardiac Surgery on CPB | NCT03513718

Studies
Acute Kidney Injury After Cardiac Surgery on CPB

NCT03513718

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Completed

Last Update Posted

Feb 13, 2024Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Acute Kidney Injury
Congenital Heart Disease
Surgery
CBP
Child, Only

Interventions

Not provided

Countries

Switzerland

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 5, 2023Actual

First Submitted Date

Apr 9, 2018

First Submission Date that Met QC Criteria

Apr 30, 2018

First Posted Date

May 1, 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

Feb 10, 2024

Last Update Posted Date

Feb 13, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Perez Maria-Helena, MD, Centre Hospitalier Universitaire VaudoisPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire VaudoisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this retrospective study is to determine the incidence and severity of acute kidney injuries (AKI) after heart surgery on cardiopulmonary bypass (CPB) in the pediatric intensive care unit (PICU) in Lausanne, Switzerland.

Detailed Description

The investigators will review in a retrospective way, all patients aged between 0 and 16 years, admitted in the PICU after cardiac surgery on CPB from 01.01.2014 to 31.12.2016. They will asses for AKI. The first step is to determine the incidence and severity, the second step is to determine the risk factors for AKI and/or protecting factors.

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

250Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence and severity of an AKI occurring during stay in the PICU	Scoring AKI with pRiffle	up to 3 month

Secondary Outcomes

Measure	Description	Time Frame
PICU stay and ventilation time	correlation between AKI and invasive ventilation/duration and PICU stay	up to 3 month
Persisting AKI after release from PICU according to RIFLE score	After leaving ICU

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- all pediatric patients (0-16 years) admitted to PICU after cardiac surgery with CPB.

Exclusion Criteria:

Preexisting kidney injury,
no preoperative creatinine lab value

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

Retrospective inclusion of all pediatric patients (0-16 years) admitted in our PICU after cardiac surgery with CPB between January 2014 and December 2016

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Hélène Perez, MD	Centre Hospitalier Universitaire Vaudois	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHUV		Lausanne	Canton of Vaud	1011	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

No sharing of patients data

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