Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00556491

Recruitment Status : Completed

First Posted : November 12, 2007

Results First Posted : March 9, 2015

Last Update Posted : December 22, 2017

Sponsor:

Collaborators:

Satellite Healthcare

Triax Pharmaceuticals

Information provided by (Responsible Party):

Tarek M. El-Achkar, St. Louis University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Kidney Failure, Acute Acute Kidney Insufficiency	Drug: minocycline Drug: placebo	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Prevention
Official Title:	Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
Study Start Date :	December 2007
Actual Primary Completion Date :	July 2011
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: minocycline	Drug: minocycline given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
Placebo Comparator: placebo	Drug: placebo placebo will be given for at least 4 doses pre-op to a maximum of 14 doses

Outcome Measures

Primary Outcome Measures :

Development of Post-operative Acute Kidney Injury [ Time Frame: up to 5 days post cardiac surgery ]
Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively

Secondary Outcome Measures :

Post Operative Hospital Days [ Time Frame: 30 days post-operative ]
On Vent >48 Hours [ Time Frame: 30 days post op ]
on ventilator > 48 hours
Infections Post Operative [ Time Frame: 30 days post operative ]
Stroke Post Operative [ Time Frame: 30 days post op ]
Re-operation [ Time Frame: 30 days post-operative ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556491

Locations

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United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63103
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467

Sponsors and Collaborators

Tarek M. El-Achkar

Satellite Healthcare

Triax Pharmaceuticals

Investigators

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Principal Investigator:	Tarek M El-Achkar, MD	St. Louis University

More Information

Publications of Results:

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.

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Responsible Party:	Tarek M. El-Achkar, Associate Professor, St. Louis University
ClinicalTrials.gov Identifier:	NCT00556491
Other Study ID Numbers:	15087
First Posted:	November 12, 2007 Key Record Dates
Results First Posted:	March 9, 2015
Last Update Posted:	December 22, 2017
Last Verified:	November 2017

Keywords provided by Tarek M. El-Achkar, St. Louis University:


renal kidney injury acute bypass	cardiac minocycline prevention Acute Kidney Failure

Additional relevant MeSH terms:

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Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases	Minocycline Anti-Bacterial Agents Anti-Infective Agents

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