Prevention of acute kidney injury by cardiopulmonary bypass: role of haptoglobin administration for hemolysis

JRCT ID: jRCT1031190038

Registered date:11/06/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Valvular heart disease
• Date of first enrollment: 11/06/2019
• Target sample size: 336
• Study type: Interventional

Intervention(s)

In patients who require a heart-lung machine for 2 or more hours, administer human haptoglobin based on plasma free hemoglobin concentration to prevent kidney damage, and examine whether the in dex of postoperative kidney damage approaches the normal value (both timing and value).
Results are compared in Intervention group or Control group randomly assigned groups.

Outcome(s)

• Primary Outcome: The occurrence of acute kidney failure is evaluated using the KDIGO classification Stage 1.

Secondary Outcome

Hemodialysis
Stage 3 in the AKI diagnostic criteria according to the KDIGO guidelines
Time from entering the ICU to extubation, and ICU stay time
Death during hospitalization or 30 days after surgery
MAKE 1, 3 and 5 years

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients aged >=20 years
2) Patients undergoing heart surgeries under artificial heart-lung machine for a long period of time at Tokyo Women's Medical University Hospital (Definition of long period of time: 2 hours or more)
3) Patients who have written consent to participate in this study

Exclude criteria

1) Dialysis patients, after kidney transplantation, on
e kidney
2) Congenital kidney disease
3) Emergency surgery

Related Information

• Primary Sponsor: Nagasaka Yasuko
• Source(s) of Monetary Support: Japan Blood Products Organization All rights reserved.,This study is supported by a research grant from the Department of Anesthesiology, Tokyo Women's Medical University