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Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00556491
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : March 9, 2015
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
Satellite Healthcare
Triax Pharmaceuticals
Information provided by (Responsible Party):
Tarek M. El-Achkar, St. Louis University

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Acute Acute Kidney Insufficiency Drug: minocycline Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
Study Start Date : December 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: minocycline Drug: minocycline
given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses

Placebo Comparator: placebo Drug: placebo
placebo will be given for at least 4 doses pre-op to a maximum of 14 doses




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


Secondary Outcome Measures :
  1. Post Operative Hospital Days [ Time Frame: 30 days post-operative ]
  2. On Vent >48 Hours [ Time Frame: 30 days post op ]
    on ventilator > 48 hours

  3. Infections Post Operative [ Time Frame: 30 days post operative ]
  4. Stroke Post Operative [ Time Frame: 30 days post op ]
  5. Re-operation [ Time Frame: 30 days post-operative ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556491


Locations
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63103
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Tarek M. El-Achkar
Satellite Healthcare
Triax Pharmaceuticals
Investigators
Principal Investigator: Tarek M El-Achkar, MD St. Louis University

Publications of Results:
Responsible Party: Tarek M. El-Achkar, Associate Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT00556491     History of Changes
Other Study ID Numbers: 15087
First Posted: November 12, 2007    Key Record Dates
Results First Posted: March 9, 2015
Last Update Posted: December 22, 2017
Last Verified: November 2017

Keywords provided by Tarek M. El-Achkar, St. Louis University:
renal
kidney
injury
acute
bypass
cardiac
minocycline
prevention
Acute Kidney Failure

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents