Acute Kidney Injury After Cardiac Surgery on CPB

February 10, 2024 updated by: Perez Maria-Helena, Centre Hospitalier Universitaire Vaudois

Incidence of Acute Kidney Injury After Cardiac Surgery on Cardiopulmonary Bypass in the Pediatric Intensive Care Unit of Lausanne. A Retrospective Study

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Marie-Hélène Perez, MD, Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 5, 2023

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 1, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No sharing of patients data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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