Hemodynamic Management guided by the Hypotension Prediction Index in Abdominal Surgery: A Multicenter Randomized Clinical Trial

Abstract

Background: Postoperative acute kidney injury (AKI) after major abdominal surgery leads to poor outcomes. The Hypotension Prediction Index (HPI) may aid in managing intraoperative hemodynamic instability. This study assessed if HPI-guided therapy reduces moderate-to-severe AKI incidence in moderate-to-high-risk elective abdominal surgery patients.

Methods: This multicenter randomized trial was conducted from October 2022 to February 2024 across 28 hospitals evaluating HPI-guided management compared to a wide range of real-world hemodynamic approaches. 917 patients (≥65 years or >18 years with ASA status >II) undergoing moderate-to-high-risk elective abdominal surgery were included in the intention-to-treat analysis. HPI-guided management triggered interventions when the HPI exceeded 80, using fluids and/or vasopressors/inotropes based on hemodynamic data. The primary outcome was the incidence of moderate-to-severe AKI within the first 7 days after surgery. Secondary outcomes included overall complications, the need for renal replacement therapy, duration of hospital stay, and 30-day mortality.

Results: Median age was 71 years (IQR, 65-77) in the HPI group and 70 years (IQR, 63-76) in standard care group. ASA status III/IV was 58.3% (268/459) in the HPI group and 57.9% (263/458) in standard care group. The incidence of moderate-to-severe AKI was 6.1% (28/459) in the HPI group and 7.0% (32/458) in the standard care group (RR 0.89, 95% 0.54-1.49; P=0.66). Overall complications occurred in 31.9% (146/459) of the HPI group and 29.7% (136/458) of the standard care group (RR 1.08, 95% CI 0.85-1.37; P = 0.52). The incidence of renal replacement therapy did not differ between groups. Median length of hospital stay was 6 days (IQR, 4-10) in both groups. The 30-day mortality was 1.1% (5/459) in the HPI group versus 0.9% (4/458) in standard care group (RR 1.35, 95% CI 0.36-5.10; P = 0.66).

Conclusions: HPI-guided hemodynamic therapy did not reduce the incidence of postoperative AKI or overall complications compared to standard care.

Clinicaltrialsgov identifier: NCT05569265.