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Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

NCT ID: NCT00556491

Last Updated: 2017-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Failure, Acute Acute Kidney Insufficiency

Keywords

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renal kidney injury acute bypass cardiac minocycline prevention Acute Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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minocycline

Group Type ACTIVE_COMPARATOR

minocycline

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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minocycline

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Satellite Healthcare

OTHER

Sponsor Role collaborator

Triax Pharmaceuticals

UNKNOWN

Sponsor Role collaborator

Tarek M. El-Achkar

OTHER

Sponsor Role lead

Responsible Party

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Tarek M. El-Achkar

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tarek M El-Achkar, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

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Saint Louis University

St Louis, Missouri, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25348221 (View on PubMed)

Other Identifiers

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15087

Identifier Type: -

Identifier Source: org_study_id