Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

November 27, 2017 updated by: Tarek M. El-Achkar
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63103
        • Saint Louis University
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 5 days post cardiac surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Hospital Days
Time Frame: 30 days post-operative
30 days post-operative
On Vent >48 Hours
Time Frame: 30 days post op
on ventilator > 48 hours
30 days post op
Infections Post Operative
Time Frame: 30 days post operative
30 days post operative
Stroke Post Operative
Time Frame: 30 days post op
30 days post op
Re-operation
Time Frame: 30 days post-operative
30 days post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarek M. El-Achkar

Collaborators

Satellite Healthcare
Triax Pharmaceuticals

Investigators

  • Principal Investigator: Tarek M El-Achkar, MD, St. Louis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (Estimate)

November 12, 2007

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15087

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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