N/A
N=40
Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
Kidney Failure, Acute · Acute Kidney Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00556491 ↗Enrolled (actual)
40
Serious AEs
18.4%
Results posted
Mar 2015
Primary outcome: Primary: Development of Post-operative Acute Kidney Injury — 10; 7 participants meeting primary oputcome
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- minocycline (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tarek M. El-Achkar
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Development of Post-operative Acute Kidney Injury |
10; 7 | — |
| SECONDARY Post Operative Hospital Days |
8.7; 9.8 | — |
| SECONDARY On Vent >48 Hours |
15.8; 26.3 | — |
| SECONDARY Infections Post Operative |
2; 3 | — |
| SECONDARY Stroke Post Operative |
2; 0 | — |
| SECONDARY Re-operation |
2; 1 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00556491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.