A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients.

Background: This prospective multicentre pilot study of patients scheduled for elective major abdominal surgery aimed to validate the fluid challenge (FC) proposed by the closed-loop (CL) system via anaesthesiologist assessment. Methods: This was a phase II trial consisting of two inclusion stages (SIMON method). Each FC (250 mL saline solution for 10 min) proposed by the CL was systematically validated by the anaesthesiologist who could either confirm or refuse the FC or give FC without the CL system. A ≥ 95% agreement between the CL and the anaesthesiologist was considered acceptable. Results: The study was interrupted after interim analysis of the first 19 patients (10 men, median age = 61 years, median body mass index = 26 kg/m2). The anaesthesiologists accepted 165/205 (80%) of fluid boluses proposed by the CL. Median cardiac index (CI) was 2.9 (interquartile: IQ (2.7; 3.4) L/min/m2) and the median coefficient of variation (CV) for CI was 13% (10; 17). Fifteen out of nineteen patients (79%) had a mean CI > 2.5 L/min/m2 or spent > 85% surgery time with pulse pressure variation < 13%. No adverse events related to the CL were reported. Conclusion: In this study of patients scheduled for elective major abdominal surgery, the agreement between CL and anaesthesiologist for giving fluid challenge was 80%, suggesting that CL cannot replace the physician but could help in decision making.

Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial.

Importance: Perioperative hypotension is associated with an increase in postoperative morbidity and mortality, but the appropriate management strategy remains uncertain. Objective: To evaluate whether an individualized blood pressure management strategy tailored to individual patient physiology could reduce postoperative organ dysfunction. Design, Setting, and Participants: The Intraoperative Norepinephrine to Control Arterial Pressure (INPRESS) study was a multicenter, randomized, parallel-group clinical trial conducted in 9 French university and nonuniversity hospitals. Adult patients (n = 298) at increased risk of postoperative complications with a preoperative acute kidney injury risk index of class III or higher (indicating moderate to high risk of postoperative kidney injury) undergoing major surgery lasting 2 hours or longer under general anesthesia were enrolled from December 4, 2012, through August 28, 2016 (last follow-up, September 28, 2016). Interventions: Individualized management strategy aimed at achieving a systolic blood pressure (SBP) within 10% of the reference value (ie, patient's resting SBP) or standard management strategy of treating SBP less than 80 mm Hg or lower than 40% from the reference value during and for 4 hours following surgery. Main Outcomes and Measures: The primary outcome was a composite of systemic inflammatory response syndrome and dysfunction of at least 1 organ system of the renal, respiratory, cardiovascular, coagulation, and neurologic systems by day 7 after surgery. Secondary outcomes included the individual components of the primary outcome, durations of ICU and hospital stay, adverse events, and all-cause mortality at 30 days after surgery. Results: Among 298 patients who were randomized, 292 patients completed the trial (mean [SD] age, 70 [7] years; 44 [15.1%] women) and were included in the modified intention-to-treat analysis. The primary outcome event occurred in 56 of 147 patients (38.1%) assigned to the individualized treatment strategy vs 75 of 145 patients (51.7%) assigned to the standard treatment strategy (relative risk, 0.73; 95% CI, 0.56 to 0.94; P = .02; absolute risk difference, -14%, 95% CI, -25% to -2%). Sixty-eight patients (46.3%) in the individualized treatment group and 92 (63.4%) in the standard treatment group had postoperative organ dysfunction by day 30 (adjusted hazard ratio, 0.66; 95% CI, 0.52 to 0.84; P = .001). There were no significant between-group differences in severe adverse events or 30-day mortality. Conclusions and Relevance: Among patients predominantly undergoing abdominal surgery who were at increased postoperative risk, management targeting an individualized systolic blood pressure, compared with standard management, reduced the risk of postoperative organ dysfunction. Trial Registration: clinicaltrials.gov Identifier: NCT01536470.

Interest of Urinary [TIMP-2] × [IGFBP-7] for Predicting the Occurrence of Acute Kidney Injury After Cardiac Surgery: A Gray Zone Approach.

BACKGROUND: This study assessed the ability of 3-hour postoperative urinary tissue inhibitor of metalloproteinases-2 × insulin-like growth factor binding protein-7 ([TIMP-2] × [IGFBP-7]) to predict postoperative acute kidney injury (AKI) in patients undergoing cardiopulmonary bypass during cardiac surgery. METHODS: Patients undergoing cardiac surgery with cardiopulmonary bypass were eligible for this study. Patients with initial chronic renal insufficiency requiring renal replacement therapy, patients <18 years of age, and parturients were not included. Anesthesia and hemodynamic management followed current practices. Urinary [TIMP2] × [IGFBP-7] was measured in 3-hour postoperative period. The primary objective was the occurrence of AKI (Kidney Disease: Improving Global Outcome [KDIGO] stage >0) within the first 48 hours postoperatively. The ability of urinary [TIMP-2] × [IGFBP-7] to predict postoperative AKI was assessed by building a receiver operating characteristic curve (with 95% confidence interval [CI] and by a gray zone approach that allowed either the prediction or the exclusion of postoperative AKI with a sensitivity >0.90 and a specificity >0.90). RESULTS: AKI occurred in 34 of 93 patients included (37%). The area under the receiver operating characteristic curve of urinary [TIMP-2] × [IGFBP-7] was 0.73 (95% CI, 0.62-0.83). The best cutoff value for urinary [TIMP-2] × [IGFBP-7] in predicting AKI was 0.3 ng/mL/1000 [0.09-1.40] (sensitivity = 76%; 95% CI, 73-97, specificity = 64%; 95% CI, 42-69). Urinary [TIMP-2] × [IGFBP-7] of <0.09 ng/mL/1000 and >1.40 ng/mL/1000 had a sensitivity and specificity >90% in predicting postoperative AKI. Fifty-nine patients (63%) were within the gray zone. CONCLUSIONS: In patients undergoing cardiopulmonary bypass during cardiac surgery, urinary [TIMP-2] × [IGFBP-7] could not accurately predict the occurrence of postoperative AKI.