Kidney Failure, AcuteNCT00556491
Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
A study testing minocycline in people with Kidney Failure, Acute and Acute Kidney Insufficiency, run by Tarek M. El-Achkar at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Failure, Acute, Acute Kidney Insufficiency
- What is being tested?
- minocycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Saint Louis University
St Louis, Missouri, 63103
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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.
- Conditions
- Kidney Failure, Acute, Acute Kidney Insufficiency
- Being tested
- minocycline, placebo
- Keywords
- renal, kidney, injury, acute, bypass, cardiac, minocycline, prevention, Acute Kidney Failure
- Medical subject headings
- Acute Kidney Injury, Wounds and Injuries, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minocyclineDrug
given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
placeboDrug
placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
| Study group | Role | What they receive |
|---|---|---|
| minocycline | Active comparator | Not described Receives: Drug: minocycline |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Post-operative Acute Kidney Injury
Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively
Measured: up to 5 days post cardiac surgery
Secondary outcomes (5)
Post Operative Hospital Days
Measured: 30 days post-operative
On Vent >48 Hours
on ventilator > 48 hours
Measured: 30 days post op
Infections Post Operative
Measured: 30 days post operative
Stroke Post Operative
Measured: 30 days post op
Re-operation
Measured: 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionJul 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarek M. El-Achkar
- Sponsor type
- University, hospital or other
- Collaborators
- Satellite Healthcare, Triax Pharmaceuticals
- Responsible party
- Sponsor-investigator, Tarek M. El-Achkar, St. Louis University
- Investigators
- Tarek M El-Achkar, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556491
- Sponsor's protocol ID
- 15087
- Status last verified
- Nov 2017
- First submitted
- 9 Nov 2007
- Last updated
- 22 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Golestaneh L, Lindsey K, Malhotra P, Kargoli F, Farkas E, Barner H, Qazi R, Schmidt A, Rauchman M, Al-Aly Z, Johnson R, Martin K, Dagher P, Friedman A, El-Achkar TM. Acute kidney injury after cardiac surgery: is minocycline protective? J Nephrol. 2015 Apr;28(2):193-9. doi: 10.1007/s40620-014-0152-2. Epub 2014 Oct 28.
PubMed 25348221
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00556491
- Acronym / sponsor ID
- 15087
- Conditions
- Kidney Failure, Acute, Acute Kidney Insufficiency
- Keywords
- renal, kidney, injury, acute, bypass, cardiac, minocycline, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tarek M. El-AchkarUniversity, hospital or other
- Collaborators
- Satellite Healthcare, Triax Pharmaceuticals
- Study start
- Dec 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Posted 9 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minocycline | Active comparator | Drug: minocycline |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minocyclinegiven at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses | Drug | minocycline |
| placeboplacebo will be given for at least 4 doses pre-op to a maximum of 14 doses | Drug | placebo |
Primary outcome
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
5 secondary outcomes
Post Operative Hospital Days
Time frame: 30 days post-operative
On Vent >48 Hours
Time frame: 30 days post op
Infections Post Operative
Time frame: 30 days post operative
Stroke Post Operative
Time frame: 30 days post op
Re-operation
Time frame: 30 days post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25348221Golestaneh L, Lindsey K, Malhotra P, Kargoli F, Farkas E, Barner H, Qazi R, Schmidt A, Rauchman M, Al-Aly Z, Johnson R, Martin K, Dagher P, Friedman A, El-Achkar TM. Acute kidney injury after cardiac surgery: is minocycline protective? J Nephrol. 2015 Apr;28(2):193-9. doi: 10.1007/s40620-014-0152-2. Epub 2014 Oct 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek M El-Achkar, MD principal investigator
St. Louis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minocycline in people with Kidney Failure, Acute and Acute Kidney Insufficiency, run by Tarek M. El-Achkar at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Post-operative Acute Kidney Injury (time frame: up to 5 days post cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00556491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.