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Completed

NCT Number: NCT00556491

Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

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.

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Key information

Conditions

Kidney Failure, Acute Acute Kidney Injury Acute Kidney Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Wounds and Injuries cyclopia sequence

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis University, St Louis, Missouri, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minocycline

Drug

given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tarek M. El-Achkar

Other

Collaborators

  • Satellite Healthcare
  • Triax Pharmaceuticals

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Nov 12, 2007
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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