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Background: Ulinastatin is a serine protease inhibitor with anti-inflammatory effects. Evidence for the effects of ulinastatin on renal outcomes remains sparse in patients receiving cardiac surgery with cardiopulmonary bypass (CPB).Methods: This prospective cohort study evaluated 413 patients aged 18–70 years who underwent cardiac surgery with CPB, from Aug 2008 to Jul 2019 in Fuwai Hospital, Beijing ,China. The ulinastatin group included 135 patients who received intravenous ulinastatin (1×106 U) after induction of anesthesia. The remaining 278 patients without ulinastatin served as the control group. The primary outcome was the rate of new-onset postoperative acute kidney injury (AKI). The secondary outcome was renal replacement therapy(RRT). Serum creatinine, plasma NGAL, and serum IL-6 levels were evaluated and the CSANGAL Score was calculated. In addition, in-hospital mortality, morbidity, adverse outcomes and 10-year follow-up the survival rate was analyzed.Results: Rate of new-onset AKI was significantly lower in the ulinastatin group than in the control group (20.00% vs. 32.40%, p=0.009). There was no significant difference of RRT between the two groups (0.00% vs. 2.16%, p=0.09). In-hospital mortality, morbidity, and adverse outcomes were comparable between the two groups except for a significantly lower incidence of respiratory failure in the ulinastatin group compared with the control group (0.76% vs. 5.40%, p=0.02). The 10-year follow-up survival rates did not differ significantly between the two groups.Conclusions: Ulinastatin significantly reduced postope rative AKI and respiratory failure in patients receiving cardiac surgery with CPB. But ulinastatin did not reduce ICU and hospital stay and mortality.Clinical trial registration: NCT01060189 |
