Skip to content

Effect of Perioperative Inhaled Nitric Oxide on Postoperative Acute Kidney Injury in On-pump Cardiac Surgery Patients with Chronic Heart Failure: A Multicenter Randomized Controlled Trial

Effect of Perioperative Inhaled Nitric Oxide on Postoperative Acute Kidney Injury in On-pump Cardiac Surgery Patients with Chronic Heart Failure: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128412
Enrollment
Unknown
Registered
2026-07-20
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute kidney injury

Interventions

NO group:NO group will receive 40 ppm inhaled NO during CPB through the membrane oxygenator, followed by continuously administration of 40 ppm NO through the ventilator circuit until 12 hours after su
Control Group:NO therapy is not used during CPB or after surgery
routine surgical management and treatment measures are followed.

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age =18 years old 2. Planning to undergo heart surgery with cardiopulmonary bypass, with an expected bypass time of over 90 minutes; the planned heart surgeries include: Simple coronary artery bypass grafting (CABG) Simple valve surgery Combined surgeries [combined valve surgery (mitral valve repair/replacement and aortic valve repair/replacement); CABG plus valve surgery (mitral valve repair/replacement and/or aortic valve repair/replacement); valve surgery (mitral valve repair/replacement and/or aortic valve repair/replacement); aortic surgery (major vessels surgery without deep hypothermic circulatory arrest); CABG plus aortic surgery (major vessels surgery without deep hypothermic circulatory arrest)] 3. Meet the CHF diagnostic criteria 4. Study participants sign written informed consent and acknowledge the risks and benefits stated in the consent form.

Exclusion criteria

Exclusion criteria: 1. Participated in another clinical trial within the past 1 month; 2. Age <18 years; 3. Undergoing emergency surgery; 4. Undergoing LVAD surgery, heart transplant, or combined heart-lung transplant; 5. Undergoing a second chest surgery; 6. Undergoing hybrid surgery; 7. Undergoing major vascular surgery requiring deep hypothermic circulatory arrest under cardiopulmonary bypass; 8. Preoperative hemodynamic instability (systolic BP <90 mmHg) or preoperative use of vasoactive drugs; 9. Preoperative (from admission to surgery) acute kidney injury defined by KDIGO criteria (serum creatinine rise =26.5 µmol/L within 48 hours, or a rise to =1.5 times baseline within 7 days); 10. Preoperative CKD stage 4-5 or using renal replacement therapy; 11. Having severe infection, tumors, active bleeding, or severe liver, lung, or kidney disease; 12. Allergic to NO or contraindicated: known history of allergy to inhaled NO or severe adverse reactions; 13. Known hemolysis (intravascular or extravascular) before surgery; 14. Preoperative hemoglobin <90 g/L; 15. Or other conditions that the investigator considers unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
The incidence of AKI within 7 days after cardiac surgery;

Secondary

MeasureTime frame
AKI stage within 7 days after cardiac surgery;The levels of plasma neutrophil gelatinase-associated lipocalin (NGAL);The levels of plasma malondialdehyde (MDA);Major perioperative complications;duration of postoperative mechanical ventilation;Length of ICU stay;Length of hospital stay;in-hospital mortality;

Countries

China

Contacts

Public ContactBingyang Ji

Fuwai Hospital, Chinese Academy of Medical Sciences

jibingyang@fuwai.com+86 138 0125 1767

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026