Trial Outcomes & Findings for The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury (NCT NCT03007537)

NCT ID: NCT03007537

Last Updated: 2023-01-26

Results Overview

Occurrence of acute kidney injury according to KDIGO guideline

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2023-01-26

Participant Flow

Participant milestones

Measure	Control Group 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery 0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases	Erythropoietin Group 10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery Erythropoietin: 10000 IU erythropoietin, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases
Overall Study STARTED	51	50
Overall Study COMPLETED	46	46
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control Group n=46 Participants 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery 0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases	Erythropoietin Group n=46 Participants 10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery Erythropoietin: 10000 IU erythropoietin, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=46 Participants	0 Participants n=46 Participants	0 Participants n=92 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=46 Participants	41 Participants n=46 Participants	81 Participants n=92 Participants
Age, Categorical >=65 years	6 Participants n=46 Participants	5 Participants n=46 Participants	11 Participants n=92 Participants
Sex: Female, Male Female	28 Participants n=46 Participants	28 Participants n=46 Participants	56 Participants n=92 Participants
Sex: Female, Male Male	18 Participants n=46 Participants	18 Participants n=46 Participants	36 Participants n=92 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
serum creatinine	74.5 μmo/L STANDARD_DEVIATION 27.6 • n=46 Participants	76.0 μmo/L STANDARD_DEVIATION 26.2 • n=46 Participants	75.2 μmo/L STANDARD_DEVIATION 26.6 • n=92 Participants

PRIMARY outcome

Timeframe: 7 days

Occurrence of acute kidney injury according to KDIGO guideline

Outcome measures

Measure	Control Group n=46 Participants 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery 0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases	Erythropoietin Group n=46 Participants 10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery Erythropoietin: 10000 IU erythropoietin, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases
Number of Participants With Acute Kidney Injury	15 participants	9 participants

SECONDARY outcome

Timeframe: 3 months

suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours.

Outcome measures

Measure	Control Group n=46 Participants 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery 0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases	Erythropoietin Group n=46 Participants 10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery Erythropoietin: 10000 IU erythropoietin, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases
Number of Participants With Renal Replacement Therapy	0 participants	0 participants

Adverse Events

Control Group

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Erythropoietin Group

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control Group n=46 participants at risk 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery 0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases	Erythropoietin Group n=46 participants at risk 10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery Erythropoietin: 10000 IU erythropoietin, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases
Vascular disorders Thrombotic events	0.00% 0/46 • 3 months pulmonary infection, thrombotic events	0.00% 0/46 • 3 months pulmonary infection, thrombotic events
Infections and infestations pulmonary infection	21.7% 10/46 • Number of events 10 • 3 months pulmonary infection, thrombotic events	19.6% 9/46 • Number of events 9 • 3 months pulmonary infection, thrombotic events

Other adverse events

Adverse event data not reported

Additional Information

Dr. Xiaobin Ji

Nanjing First Hospital, Nanjing Medical University

Phone: 13705174622

Email: xbji007@126.com

Results disclosure agreements

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