Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

This study has been completed.
Sponsor:
Collaborators:
Satellite Healthcare
Triax Pharmaceuticals
Information provided by (Responsible Party):
Tarek M. El-Achkar, Saint Louis University
ClinicalTrials.gov Identifier:
NCT00556491
First received: November 9, 2007
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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 Intervention
Kidney Failure, Acute
Acute Kidney Insufficiency
Drug: minocycline
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • development of post-operative acute kidney injury [ Time Frame: up to 5 days post cardiac surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • composite end-point of secondary outcomes of death, hospital days, major complications [ Time Frame: 30 days post-operative ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: December 2007
Study Completion Date: December 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Tarek M. El-Achkar, Associate Professor, Saint Louis University
ClinicalTrials.gov Identifier: NCT00556491     History of Changes
Other Study ID Numbers: 15087
Study First Received: November 9, 2007
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Louis University:
renal
kidney
injury
acute
bypass
cardiac
minocycline
prevention
Acute Kidney Failure
Minocycline

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

ClinicalTrials.gov processed this record on September 18, 2014