Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Kidney Failure, Acute Clinical Trial

Official title:

Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556491
• Other study ID #: 15087
• Status: Completed
• Phase: N/A
• First received: November 9, 2007
• Last updated: November 27, 2017
• Start date: December 2007
• Est. completion date: December 2013

Study information

• Verified date: November 2017
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Insufficiency
• Kidney Failure, Acute
• Renal Insufficiency

Intervention

Drug:
• minocycline
given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
• placebo
placebo will be given for at least 4 doses pre-op to a maximum of 14 doses

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Tarek M. El-Achkar	Satellite Healthcare, Triax Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 5 days post cardiac surgery
Secondary	Post Operative Hospital Days		30 days post-operative
Secondary	On Vent >48 Hours	on ventilator > 48 hours	30 days post op
Secondary	Infections Post Operative		30 days post operative
Secondary	Stroke Post Operative		30 days post op
Secondary	Re-operation		30 days post-operative