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

CIN Clinical Trial

— PRECISE-ICU  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791606
• Other study ID #: KLin
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Fujian Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 755
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CIN

Locations

Country	Name	City	State
China	Fujian Provincial	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Kaiyang Lin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MACEs for long-term follow up	mortality,stent restenosis, recurrent myocardial infarction, target vessel revascularization,stroke,bleeding,required renal replacement therapy	1 year
Primary	CI-AKI	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	in-hospital adverse events	congestive heart failure [CHF], bleeding, stroke, reinfarction, stent thrombosis, required renal replacement therapy, length of hospital stay, hospital costs, and mortality	1 year