Trial Outcomes & Findings for Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery (NCT NCT00556491)

NCT ID: NCT00556491

Last Updated: 2017-12-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: up to 5 days post cardiac surgery
• Results posted on: 2017-12-22

Participant Flow

Participant milestones

Measure	Minocycline minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses	Placebo placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
Overall Study STARTED	20	20
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

Baseline characteristics by cohort

Measure	Minocycline n=20 Participants minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses	Placebo n=20 Participants placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	64.1 years STANDARD_DEVIATION 9.9 • n=5 Participants	60.8 years STANDARD_DEVIATION 11.5 • n=7 Participants	62 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
kidney function	71.9 ml/min STANDARD_DEVIATION 26.4 • n=5 Participants	77.3 ml/min STANDARD_DEVIATION 27.4 • n=7 Participants	74.3 ml/min STANDARD_DEVIATION 26.9 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Minocycline n=19 Participants	Placebo n=19 Participants
Development of Post-operative Acute Kidney Injury	10 participants meeting primary oputcome	7 participants meeting primary oputcome

SECONDARY outcome

Timeframe: 30 days post-operative

Outcome measures

Measure	Minocycline n=19 Participants	Placebo n=19 Participants
Post Operative Hospital Days	8.7 days Standard Error 3.8	9.8 days Standard Error 7.2

SECONDARY outcome

Timeframe: 30 days post op

on ventilator > 48 hours

Outcome measures

Measure	Minocycline n=19 Participants	Placebo n=19 Participants
On Vent >48 Hours	15.8 percentage of participant per group	26.3 percentage of participant per group

SECONDARY outcome

Timeframe: 30 days post operative

Outcome measures

Measure	Minocycline n=19 Participants	Placebo n=19 Participants
Infections Post Operative	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days post op

Outcome measures

Measure	Minocycline n=19 Participants	Placebo n=19 Participants
Stroke Post Operative	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days post-operative

Outcome measures

Measure	Minocycline n=19 Participants	Placebo n=19 Participants
Re-operation	2 Participants	1 Participants

Adverse Events

Minocycline

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Minocycline n=19 participants at risk minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses	Placebo n=19 participants at risk placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
Vascular disorders Stroke	10.5% 2/19	0.00% 0/19
Cardiac disorders Death	0.00% 0/19	10.5% 2/19
Cardiac disorders Reop	10.5% 2/19	5.3% 1/19

Other adverse events

Adverse event data not reported

Additional Information

Tarek El-Achkar

St Louis University

Phone: 317 278 6822

Email: telachka@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place