Trial Outcomes & Findings for Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery (NCT NCT00654992)

NCT ID: NCT00654992

Last Updated: 2009-06-16

Results Overview

number of participants who had 50% increase in serum creatinine levels from baseline

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 71 participants
• Primary outcome timeframe: at any time within the first 5 days after surgery
• Results posted on: 2009-06-16

Participant Flow

Participant milestones

Measure	Erythropoietin (EPO) Group received 300 U/kg of erythropoietin intraveously following induction of anesthesia	Placebo Group received normal saline intraveously following induction of anesthesia
Overall Study STARTED	36	35
Overall Study COMPLETED	36	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery

Baseline characteristics by cohort

Measure	Erythropoietin (EPO) Group n=36 Participants received 300 U/kg of erythropoietin intraveously following induction of anesthesia	Placebo Group n=35 Participants received normal saline intraveously following induction of anesthesia	Total n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29.0 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	21 Participants n=7 Participants	42.0 Participants n=5 Participants
Age Continuous	65 years STANDARD_DEVIATION 11 • n=5 Participants	69 years STANDARD_DEVIATION 8 • n=7 Participants	67 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	12 Participants n=7 Participants	18.0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	23 Participants n=7 Participants	53.0 Participants n=5 Participants
Region of Enrollment Korea, Republic of	36 participants n=5 Participants	35 participants n=7 Participants	71.0 participants n=5 Participants

PRIMARY outcome

Timeframe: at any time within the first 5 days after surgery

number of participants who had 50% increase in serum creatinine levels from baseline

Outcome measures

Measure	Erythropoietin (EPO) Group n=36 Participants received 300 U/kg of erythropoietin intraveously following induction of anesthesia	Placebo Group n=35 Participants received normal saline intraveously following induction of anesthesia
Number of Participants Who Had AKI (Acute Kidney Injury)	3 participants	10 participants

SECONDARY outcome

Timeframe: during the first 5 days after surgery

estimated glomerular filtration rate (eGFR)as ml/min/1.73m2

Outcome measures

Measure	Erythropoietin (EPO) Group n=36 Participants received 300 U/kg of erythropoietin intraveously following induction of anesthesia	Placebo Group n=35 Participants received normal saline intraveously following induction of anesthesia
Change in Estimated Glomerular Filtration Rate (eGFR)	-1.5 ml/min/1.73m2 Standard Deviation 7.3	-9.1 ml/min/1.73m2 Standard Deviation 14.5

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Effect of erythropoietin in kidney after cardiac surgery

Seoul National University Bundang Hospital

Phone: 82-31-787-7014

Email: kyna@snubh.org

Results disclosure agreements

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