Protective effect of ulinastatin against negative inflammatory response and organ dysfunction in acute aortic dissection surgery: The PANDA trial

Ulinastatin is a protease-inhibiting drug with anti-inflammatory and other pharmacological properties. Little is known regarding its role following acute type A aortic dissection (ATAAD) surgery. We perform a randomized controlled trial to investigate the protective effect of ulinastatin against negative inflammatory response and organ dysfunction in ATAAD surgery (PANDA). The primary outcome of mean daily Sequential Organ Failure Assessment (SOFA) score from baseline to 7 days of surgery is 8.80 (SD, 4.11) in the ulinastatin group and 8.61 (SD, 4.47) in the control group (mean difference between groups was 0.04; 95% confidence interval [CI], −0.24 to 0.33; p = 0.765). Systemic inflammatory response syndrome (SIRS) within 7 days of surgery is lower in the ulinastatin group than in the control group ( p < 0.001). Additional ulinastatin to standard treatment is likely to reduce SIRS rates instead of preventing organ dysfunction, highlighting the potential importance of the benefits of anti-inflammatory pharmacotherapeutics. The trial is registered on clinicaltrials.org (NCT04711889). • Ulinastatin does not significantly reduce acute organ dysfunctions after ATAAD surgery • Ulinastatin has a protective effect against the SIRS rate within 7 days after ATAAD surgery • Ulinastatin has a neutral effect on postoperative mortality and mid-term mortality Liu et al. develop a randomized controlled trial (PANDA) to investigate the protective effect of ulinastatin against negative inflammatory response and organ dysfunctions in acute type A aortic dissection surgery. Additional ulinastatin to standard treatment could significantly reduce systemic inflammatory response syndrome, highlighting the importance of anti-inflammatory pharmacotherapeutics.