Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
Information source: St. Louis University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Failure, Acute; Acute Kidney Insufficiency
Intervention: minocycline (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: St. Louis University Official(s) and/or principal investigator(s):
Tarek M El-Achkar, MD, Principal Investigator, Affiliation: St. Louis University
Overall contact:
Tarek M El-Achkar, M.D., Phone: 314-5778765, Email: telachka@slu.edu
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.
Clinical Details
Official title: Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: development of post-operative acute kidney injury
Secondary outcome: composite end-point of secondary outcomes of death, hospital days, major complications
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Tarek M El-Achkar, M.D., Phone: 314-5778765, Email: telachka@slu.edu
Saint Louis University, Saint Louis, Missouri 63103, United States; Recruiting
Tarek M. El-Achkar, MD, Phone: 314-577-8765, Email: telachka@slu.edu
Tarek M El-Achkar, MD, Principal Investigator
Additional Information
Starting date: December 2007
Ending date: January 2011
Last updated: February 9, 2009
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