Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Not Applicable

Completed

• Conditions: Kidney Failure, Acute; Acute Kidney Insufficiency
• Interventions: Drug: minocycline; Drug: placebo

• Registration Number: NCT00556491
• Lead Sponsor: Tarek M. El-Achkar

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Study Start: 2007-12
• Primary Completion: 2011-07
• Study Completion: 2013-12
• Results First Submitted: 2015-01-11
• Results First Submitted QC: 2015-03-05
• Results First Posted: 2015-03-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
minocycline	minocycline	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Development of Post-operative Acute Kidney Injury	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 Outcome Measures

Name	Time	Method
Post Operative Hospital Days	30 days post-operative
On Vent >48 Hours	30 days post op	on ventilator \> 48 hours
Infections Post Operative	30 days post operative
Stroke Post Operative	30 days post op
Re-operation	30 days post-operative

Trial Locations

Locations (2)

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States