Effect of ulinastatin on postoperative renal function in patients undergoing robot-assisted laparoscopic partial nephrectomy: a randomized trial

Abstract

BACKGROUND: Robot-assisted laparoscopic partial nephrectomy (RLPN) is an emerging technique for treating small renal masses. Although RLPN has many advantages, ischemic kidney injury is inevitable during renal artery clamping. The overall incidence of acute kidney injury (AKI) after partial nephrectomy has been reported to be up to 39%. Moreover, effective pharmacological protection against AKI after partial nephrectomy has not yet been demonstrated. Ulinastatin has been shown to protect the kidney from ischemia/reperfusion injury via its anti-inflammatory and anti-oxidant activities. Therefore, this study aimed to evaluate the effect of ulinastatin on postoperative kidney function in patients undergoing RLPN. METHODS: In this randomized, double-blinded, placebo-controlled study, patients undergoing RLPN received either intravenous ulinastatin (100,000 units/10 kg: ulinastatin group, n = 35) or the same volume of normal saline (control group, n = 35) for 1 h starting 10 min before renal artery clamping. The primary outcome was incidence of postoperative AKI. Secondary outcomes were levels of serum creatinine, estimated glomerular filtration rate (eGFR), cystatin C, and inflammatory markers and were measured before operation and at 1, 24, 48, and 72 h postoperatively. RESULTS: The incidence of postoperative AKI was 18% in the ulinastatin group, whereas it was 30% in the control group (p = 0.251). No significant differences in postoperative changes of serum creatinine, eGFR, or cystatin C were observed between the two groups. Postoperative inflammatory markers including C-reactive protein, white blood cell count, and neutrophil percentage were significantly increased until 72 h after operation compared to the preoperative values in both groups, with no significant differences between the groups. CONCLUSIONS: Administration of ulinastatin (100,000 units/10 kg) during the warm ischemia and reperfusion periods did not show any beneficial effects on postoperative kidney function or inflammatory responses in patients undergoing RLPN.