Official Title
Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
Phase
N/ALead Sponsor
St. Louis UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Kidney Failure, Acute Acute Kidney InsufficiencyIntervention/Treatment
minocycline ...Study Participants
40This 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.
given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
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
| Event Type | Organ System | Event Term | Minocycline | Placebo |
|---|
Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively
on ventilator > 48 hours
