Nitric oxide for the prevention of postoperative acute kidney injury in patients undergoing surgery for Stanford type A aortic dissection: study protocol for a randomized controlled trial.

BACKGROUND

Acute kidney injury (AKI) is a frequent and serious complication following surgery for acute type A aortic dissection (ATAAD). Nitric oxide (NO) may reduce AKI incidence through renal-protective mechanisms, but evidence in the ATAAD population remains limited. This trial aims to evaluate whether perioperative administration of NO can reduce the incidence of postoperative AKI in this population.

METHODS

This single-center, randomized, parallel-group superiority trial will enroll 106 adult patients undergoing ATAAD emergency surgery. Participants will be randomly allocated in a 1:1 ratio to either receive 60 parts per million of NO during cardiopulmonary bypass and for 12 h post-surgery, or to receive standard care without NO. The primary outcome is AKI incidence within 48 h postoperatively, defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary outcomes include AKI severity, urine output, vasoactive-inotropic score, neutrophil gelatinase-associated lipocalin levels, sequential organ failure assessment score, ventilator support duration, intensive care unit (ICU) and hospital length of stay, and major adverse kidney events, cumulative mediastinal and pericardial drainage volume.

DISCUSSION

This trial will evaluate whether perioperative NO administration can reduce early AKI and improve renal and clinical outcomes in high-risk ATAAD patients. Findings may provide evidence for a novel nephroprotective strategy in aortic surgery.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06622291. Registered on June 26, 2024.