NCT01547455

Brief Summary

Statins were reported to have pleiotropic effects including antiinflammatory, anti-oxidative stress effects and stabilise plaque in some conditions. Some researches indicate loading dose statin can reduce contrast induced nephropathy, and the levels of inflammatory markers were significantly decreased. The investigators hypothesis loading dose atorvastatin may attenuate inflammatory response during cardiopulmonary bypass (CPB) and therefore reduce postoperative acute kidney injury in cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

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

First Submitted

Initial submission to the registry

February 26, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

1.2 years

First QC Date

February 26, 2012

Last Update Submit

July 24, 2013

Conditions

Acute Kidney Injury

Keywords

Statinkidney functionantiinflammatory effect

Outcome Measures

Primary Outcomes (1)

  • acute kidney injury

    Proportion developing AKI using AKIN criteria(stage 1,stage 2, stage3).we plan to measure serum creatinine in baseline, ICU admission,postoperative 6h、Day 1、Day 2 and Day 3.If multiple SCr was measured in one day ,then the highest value will be recorded.Also, we measure creatinine clearance via Cock-croft-Gault formula.

    72 hours after surgery

Secondary Outcomes (7)

  • Change of inflammatory biomarkers

    48h after surgery

  • Requirement of renal replacement therapy

    participants will be followed for the duration of hospital stay , an expected average of 2 weeks

  • liver function

    participants will be followed for the duration of hospital stay , an expected average of 2 weeks

  • death

    30 days after discharge from hospital

  • MACCE events

    30 days after discharge from hospital

  • +2 more secondary outcomes

Study Arms (2)

Atorvastatin

EXPERIMENTAL

participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery

Drug: Atorvastatin(Lipitor)

Control

PLACEBO COMPARATOR

Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery

Drug: Placebo

Interventions

Atorvastatin(Lipitor)DRUG

participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery

Also known as: Lipitor
Atorvastatin
PlaceboDRUG

Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years old
  • elective coronary artery bypass surgery in CPB

You may not qualify if:

  • emergent surgery
  • re-operation
  • acute kidney dysfunction
  • chronic kidney disease
  • GFR \< 60ml/min
  • liver dysfunction
  • existing myopathy
  • LEVF \< 40%
  • statin allergic or contradictive
  • pregnancy
  • breast feed period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Institute&Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Weipeng Wang, MD,PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2012

First Posted

March 7, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations

CN(1)