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Randomized Controlled Trial
. 2025 Jan 21;6(1):101888.
doi: 10.1016/j.xcrm.2024.101888.

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

Hong Liu  1 , Si-Chong Qian  2 , Kai Zhu  2 , Yi-Fei Diao  3 , Xiu-Fan Xu  3 , Zhi-Wei Tang  3 , Guo-Liang Fan  4 , Hong-Hua Yue  5 , Jun-Quan Chen  6 , Ji-Nong Yang  7 , Ying-Yuan Zhang  8 , Chao Ma  9 , Xiang Liu  10 , Ying Wu  11 , Zhong Wu  5 , Nan Liu  2 , Ao Li  3 , Bu-Qing Ni  3 , Yong-Feng Shao  12 , Sheng Zhao  13 , Hai-Yang Li  14 , Hong-Jia Zhang  2 ; China Additive Anti-inflammatory Actions for Aortopathy and Arteriopathy (5A); PANDA Trial Investigators
Affiliations
Randomized Controlled Trial

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

Hong Liu et al. Cell Rep Med. .

Abstract

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).

Keywords: mortality; systemic inflammatory response syndrome; type A aortic dissection; ulinastatin.

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Conflict of interest statement

Declaration of interests The authors declare no competing interests.

Figures

None
Graphical abstract
Figure 1
Figure 1
Recruitment and randomization of the patients CTA, computed tomography angiography; ATAAD, acute type A aortic dissection.
Figure 2
Figure 2
Kaplan-Meier estimates of the probability of survival to day 30 after surgery with landmark analysis Cumulative mortality at 30 days after surgery was estimated with Kaplan-Meier’s method and compared with the log rank test. Cox proportional hazards regression was used to estimate the hazard ratios (HRs) and their 95% confidence intervals (CIs). The shadow zone indicated the 95% CI.
Figure 3
Figure 3
Sequential trajectory of peripheral laboratory profiles of interest (A) The change of arterial lactate within 7 days after surgery. (B) The change of serum procalcitonin within 7 days after surgery. (C) The change of peripheral WBC counts within 7 days after surgery. (D) The change of serum bilirubin within 7 days after surgery. For each biomarker, the repeated-measures analysis is performed, and the p value is presented for the test of between-subjects effects. ∗Indicates the time point of intensive care unit admission immediately after surgery. Data are represented as median ± interquartile range (IQR); WBC, white blood cell.
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