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Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

T

Tarek M. El-Achkar

Status

Completed

Conditions

Acute Kidney Insufficiency
Kidney Failure, Acute

Treatments

Drug: minocycline
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups, including a placebo group

minocycline
Active Comparator group
Treatment:
Drug: minocycline
placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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