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Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Primary Purpose

Kidney Failure, Acute, Acute Kidney Insufficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

minocycline

placebo

About this trial

This is an interventional prevention trial for Kidney Failure, Acute focused on measuring renal, kidney, injury, acute, bypass, cardiac, minocycline, prevention, Acute Kidney Failure

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Saint Louis University
Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

minocycline

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Post Operative Hospital Days

On Vent >48 Hours

on ventilator > 48 hours

Infections Post Operative

Stroke Post Operative

Re-operation

Full Information

NCT ID

NCT00556491

First Posted

November 9, 2007

Last Updated

November 27, 2017

Sponsor

Tarek M. El-Achkar

Collaborators

Satellite Healthcare, Triax Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00556491

Brief Title

Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Official Title

Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tarek M. El-Achkar

Collaborators

Satellite Healthcare, Triax Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Acute, Acute Kidney Insufficiency

Keywords

renal, kidney, injury, acute, bypass, cardiac, minocycline, prevention, Acute Kidney Failure

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

minocycline

Arm Type

Active Comparator

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

minocycline

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Development of Post-operative Acute Kidney Injury

Description

Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively

Time Frame

up to 5 days post cardiac surgery

Secondary Outcome Measure Information:

Title

Post Operative Hospital Days

Time Frame

30 days post-operative

Title

On Vent >48 Hours

Description

on ventilator > 48 hours

Time Frame

30 days post op

Title

Infections Post Operative

Time Frame

30 days post operative

Title

Stroke Post Operative

Time Frame

30 days post op

Title

Re-operation

Time Frame

30 days post-operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tarek M El-Achkar, MD

Organizational Affiliation

St. Louis University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint Louis University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63103

Country

United States

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25348221

Citation

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.

Results Reference

result

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Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

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