Trial Outcomes & Findings for Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest (NCT NCT01369732)

Results Overview

Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

66 participants

Primary outcome timeframe

upto 7 days after surgery

Results posted on

2013-09-26

Participant Flow

This study was conducted at the university hospital between May 2011 and January 2013.

Six patients were dropped out regarding wrong dose-count of erythropoietin (n = 1), death within 24 hours after surgery (n = 2), and screening failure due to chronic kidney disease (n = 3).

Participant milestones

Participant milestones
Measure	Saline Group We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.	Erythropoietin Group We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
Overall Study STARTED	33	33
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline Group n=33 Participants We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.	Erythropoietin Group n=33 Participants We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.	Total n=66 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	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Age Continuous	65 years STANDARD_DEVIATION 12 • n=5 Participants	61 years STANDARD_DEVIATION 13 • n=7 Participants	63 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	20 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment Korea, Republic of	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: upto 7 days after surgery

Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: upto 7 days after surgery

Outcome measures

Outcome measures
Measure	Saline Group n=29 Participants We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.	Erythropoietin Group n=31 Participants We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
Incidence of Acute Kidney Injury Based on RIFLE Criteria	18 participants	18 participants

SECONDARY outcome

Timeframe: upto 1 month after surgery

Participants will be followed for the mortality, an expected average of 1 month after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: upto 2 weeks after surgery

Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: upto 2 weeks after surgery

Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: upto 1 month after surgery

Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.

Outcome measures

Outcome data not reported

Adverse Events

Saline Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Erythropoietin Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yon Hee Shim

Yonsei University College of Medicine

Phone: 82220193547

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place