NCT00556491

Brief Summary

This study proposes to investigate whether treatment with minocycline pre-operatively in patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce the occurence of kidney injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

November 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2007

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 9, 2015

Completed
Last Updated

December 22, 2017

Status Verified

November 1, 2017

Enrollment Period

3.6 years

First QC Date

November 9, 2007

Results QC Date

January 11, 2015

Last Update Submit

November 27, 2017

Conditions

Kidney Failure, AcuteAcute Kidney Insufficiency

Keywords

renalkidneyinjuryacutebypasscardiacminocyclinepreventionAcute Kidney Failure

Outcome Measures

Primary Outcomes (1)

  • Development of Post-operative Acute Kidney Injury

    Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively

    up to 5 days post cardiac surgery

Secondary Outcomes (5)

  • Post Operative Hospital Days

    30 days post-operative

  • On Vent >48 Hours

    30 days post op

  • Infections Post Operative

    30 days post operative

  • Stroke Post Operative

    30 days post op

  • Re-operation

    30 days post-operative

Study Arms (2)

minocycline

ACTIVE COMPARATOR
Drug: minocycline

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

minocyclineDRUG

given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses

minocycline
placeboDRUG

placebo will be given for at least 4 doses pre-op to a maximum of 14 doses

placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • planned CABG or valvular surgery with cardiopulmonary bypass
  • Serum creatinine available (within 30 days)
  • Estimated GFR 15-90ml/min using the abbreviated MDRD formula (CKD stages 2-4)

You may not qualify if:

  • Emergent or urgent surgery (to be performed within the next 36 hours)
  • End stage renal disease, or GFR \< 15ml/min (CKD stage 5)
  • Estimated GFR\>90ml/min (CKD stage 1 or no CKD)
  • Ongoing infection by positive blood, urine or sputum cultures or pneumonia on CXR
  • Allergy to minocycline or tetracyclines
  • inability to take oral medications
  • use of preoperative vasopressor agents at therapeutic doses
  • Pregnant or lactating females
  • Advanced liver disease by history or exam(cirrhosis, ascitis, jaundice)
  • Rising creatinine meeting the definition of acute kidney injury prior to surgery
  • Neurologic signs or symptoms or history of increased intracranial pressure
  • current participation in another research study involving an investigational drug or device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint Louis University

St Louis, Missouri, 63103, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

  • Golestaneh L, Lindsey K, Malhotra P, Kargoli F, Farkas E, Barner H, Qazi R, Schmidt A, Rauchman M, Al-Aly Z, Johnson R, Martin K, Dagher P, Friedman A, El-Achkar TM. Acute kidney injury after cardiac surgery: is minocycline protective? J Nephrol. 2015 Apr;28(2):193-9. doi: 10.1007/s40620-014-0152-2. Epub 2014 Oct 28.

    PMID: 25348221RESULT

MeSH Terms

Conditions

Acute Kidney InjuryWounds and Injuriescyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Tarek El-Achkar
Organization
St Louis University
telachka@iu.edu
317 278 6822

Study Officials

  • Tarek M El-Achkar, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 9, 2007

First Posted

November 12, 2007

Study Start

December 1, 2007

Primary Completion

July 1, 2011

Study Completion

December 1, 2013

Last Updated

December 22, 2017

Results First Posted

March 9, 2015

Record last verified: 2017-11

Locations

US(2)