NCT03791606

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
755

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

7 years

First QC Date

December 31, 2018

Last Update Submit

January 20, 2019

Conditions

CIN

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • in-hospital adverse events

    1 year

Other Outcomes (1)

  • MACEs for long-term follow up

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Critically ill patients undergoing PCI at ICU were enrolled

You may qualify if:

  • Critically ill patients undergoing PCI at ICU

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Provincial

Fuzhou, Fujian, 350001, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Fujian Provincial Hospital

Study Record Dates

First Submitted

December 31, 2018

First Posted

January 2, 2019

Study Start

January 1, 2012

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

CN(1)