Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

This study is currently recruiting participants.

Verified by St. Louis University, February 2009

First Received: November 9, 2007 Last Updated: February 9, 2009 History of Changes

Sponsor:	St. Louis University
Collaborators:	Satellite Healthcare, Norman Coplon Grant Triax Pharmaceuticals
Information provided by:	St. Louis University
ClinicalTrials.gov Identifier:	NCT00556491

Purpose

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	Intervention
Kidney Failure, Acute Acute Kidney Insufficiency	Drug: minocycline Drug: placebo

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Kidney Failure Surgery

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

Further study details as provided by St. Louis University:

Primary Outcome Measures:

development of post-operative acute kidney injury [ Time Frame: up to 5 days post cardiac surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

composite end-point of secondary outcomes of death, hospital days, major complications [ Time Frame: 30 days post-operative ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	126
Study Start Date:	December 2007
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556491

Contacts

Contact: Tarek M El-Achkar, M.D.

314-5778765

telachka@slu.edu

Locations

United States, Missouri
Saint Louis University	Recruiting
Saint Louis, Missouri, United States, 63103
Contact: Tarek M. El-Achkar, MD 314-577-8765 telachka@slu.edu
Principal Investigator: Tarek M El-Achkar, MD

Sponsors and Collaborators

St. Louis University

Satellite Healthcare, Norman Coplon Grant

Triax Pharmaceuticals

Investigators

Principal Investigator:

Tarek M El-Achkar, MD

St. Louis University

More Information

No publications provided

Responsible Party:	St Louis University ( Tarek El-Achkar, MD )
Study ID Numbers:	15087
Study First Received:	November 9, 2007
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00556491 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Louis University:

renal
kidney
injury
acute
bypass

cardiac
minocycline
prevention
Acute Kidney Failure
Minocycline

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Minocycline
Renal Insufficiency
Urologic Diseases
Therapeutic Uses

Kidney Diseases
Renal Insufficiency, Acute
Kidney Failure, Acute
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010