Official Title: “Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: minocycline
• Placebo Comparator: placebo

Primary Measures

• development of post-operative acute kidney injury
  • Time Frame: up to 5 days post cardiac surgery
    Safety Issue?: Yes

Secondary Measures

• composite end-point of secondary outcomes of death, hospital days, major complications
  • Time Frame: 30 days post-operative
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: St. Louis University

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Tarek M El-Achkar, M.D. 314-5778765 telachka@slu.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00556491

Study ID Number: 15087

ClinicalTrials.gov Identifier: NCT00556491

Health Authority: United States: Institutional Review Board