Perioperative Nitric Oxide Conditioning Reduces Acute Kidney Injury in Cardiac Surgery Patients with Chronic Kidney Disease (the DEFENDER-trial): a Randomized Controlled Trial
Abstract
BACKGROUND
Postoperative Acute kidney injury (AKI) is a significant concern for cardiac surgery patients with chronic kidney disease (CKD). Effective pharmacological interventions to mitigate these risks are urgently needed. This study aimed to evaluate the efficacy and safety of perioperative nitric oxide (NO) administration in preventing AKI and limiting CKD progression in patients undergoing cardiac surgery.
METHODS
A total of 136 patients with CKD undergoing elective cardiac surgery with cardiopulmonary bypass (CPB) were randomized into two equal groups: the NO group (n=68), receiving 80 parts per million NO during the intraoperative period and for 6 hours post-surgery, and the control group (n=68), receiving a sham treatment. The primary outcome was AKI incidence within 7 days post-surgery.
RESULTS
AKI incidence was significantly lower in the NO group (16/68 patients, 23.5%) compared to the control group (27/68 patients, 39.7%) with a relative risk (RR) of 0.59 (95% CI 0.35-0.99; р=0.043). Six months post-surgery, the glomerular filtration rate was higher in the NO group (50 mL/min/1.73 m2 [45; 54]) compared to the control group (45 mL/min/1.73 m2 [41; 51], p=0.038). Postoperative pneumonia was significantly less frequent in the NO group: 10/68 (14.7%) vs 20/68 (29.4%) RR 0.5; (95% CI 0.25-0.99; р=0.039). NO administration was safe: methemoglobin and nitrogen dioxide levels remained within acceptable ranges, oxidative-nitrosyl stress did not increase, and there were no…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 136 participants or records.
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