Risk Factors,PREvention and OutComes for CI-AKI in PatientS undErgoing PCI at Intensive Care Unit(PRECISE-ICU) (PRECISE-ICU)

January 20, 2019 updated by: Kaiyang Lin

Risk Factors,PREvention and outComes for Contrast-Induced Acute Kidney Injury in patientS undErgoing Percutaneous Coronary Intervention at Intensive Care Unit：a Single-center Cohort Study(PRECISE-ICU)

A retrospective, observational study included all consecutively critically ill patients undergoing percutaneous coronary intervention(PCI) at intensive care unit (ICU) in Fujian Provincial Hospital from January 1st 2012 to December 31st 2018. The aim was to determine the incidence,risk factors,prophylactic strategy and outcomes of CI-AKI in critically ill patients undergoing PCI.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

755

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

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Provincial

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Critically ill patients undergoing PCI at ICU were enrolled

Description

Inclusion Criteria:

  • Critically ill patients undergoing PCI at ICU

Exclusion Criteria:

  • pregnancy
  • lactation
  • end-stage renal disease (eGFR <15 mL/min/1.73 m2)
  • long-term dialysis treatment
  • intravascular administration of contrast medium within the last 7 or 3 days postoperatively

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CI-AKI
Time Frame: 1 year
an absolute SCr increase ≥0.3 mg/dL or a relative increase in SCr ≥50% within 48 hours of contrast medium exposure
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-hospital adverse events
Time Frame: 1 year
congestive heart failure [CHF], bleeding, stroke, reinfarction, stent thrombosis, required renal replacement therapy, length of hospital stay, hospital costs, and mortality
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACEs for long-term follow up
Time Frame: 1 year
mortality,stent restenosis, recurrent myocardial infarction, target vessel revascularization,stroke,bleeding,required renal replacement therapy
1 year

Collaborators and Investigators

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

Sponsor

Kaiyang Lin

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)

January 1, 2012

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

December 31, 2018

First Submitted That Met QC Criteria

December 31, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 20, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • KLin

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.

Clinical Trials on CIN

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe