Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Conditions
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Kidney Failure, Acute, Acute Kidney Insufficiency

Intervention / Treatment
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* Drug: minocycline
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Hospital Days |  | 30 days post-operative | 
| On Vent >48 Hours | on ventilator > 48 hours | 30 days post op | 
| Infections Post Operative |  | 30 days post operative | 
| Stroke Post Operative |  | 30 days post op | 
| Re-operation |  | 30 days post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal, kidney, injury, acute, bypass, cardiac, minocycline, prevention, Acute Kidney Failure