Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial

Abstract

Background: Despite several clinical trials on haemodynamic therapy, the optimal intraoperative haemodynamic management for high-risk patients undergoing major abdominal surgery remains unclear. We tested the hypothesis that personalised haemodynamic management targeting each individual's baseline cardiac index at rest reduces postoperative morbidity. Methods: In this single-centre trial, 188 high-risk patients undergoing major abdominal surgery were randomised to either routine management or personalised haemodynamic management requiring clinicians to maintain personal baseline cardiac index (determined at rest preoperatively) using an algorithm that guided intraoperative i.v. fluid and/or dobutamine administration. The primary outcome was a composite of major complications (European Perioperative Clinical Outcome definitions) or death within 30 days of surgery. Secondary outcomes included postoperative morbidity (assessed by a postoperative morbidity survey), hospital length of stay, mortality within 90 days of surgery, and neurocognitive function assessed after postoperative Day 3. Results: The primary outcome occurred in 29.8% (28/94) of patients in the personalised management group, compared with 55.3% (52/94) of patients in the routine management group (relative risk: 0.54, 95% confidence interval [CI]: 0.38 to 0.77; absolute risk reduction: e25.5%, 95% CI: e39.2% to e11.9%; P<0.001). One patient assigned to the personalised management group, compared with five assigned to the routine management group, died within 30 days after surgery (P¼0.097). There were no clinically relevant differences between the two groups for secondary outcomes. Conclusions: In high-risk patients undergoing major abdominal surgery, personalised haemodynamic management reduces a composite outcome of major postoperative complications or death within 30 days after surgery compared with routine care. Clinical trial registration: NCT02834377.

Computer-assisted Individualized Hemodynamic Management Reduces Intraoperative Hypotension in Intermediate- and High-risk Surgery: A Randomized Controlled Trial

“…28,29 Futier et al 11 also reported that "individualized" arterial pressure management resulted in less postoperative organ dysfunction. More recently, Nicklas et al 12 demonstrated that individualizing hemodynamic management by using patient baseline cardiac index value as a target to guide fluid administration resulted in fewer postoperative complications. However, adoption of these strategies by clinicians has been slow, and even if used during surgery, results may be limited because of poor protocol compliance.…”

Perioperative Individualized Goal Directed Therapy for Cardiac Surgery: A Historical-Prospective, Comparative Effectiveness Study

“…These thresholds were determined intraoperatively, post-CPB, by the intraoperative team (surgery and anesthesiology) utilizing a variety of inputs including: patient's comorbidity, pre-CPB and post-CPB HD data, echocardiography, cerebral oximetry, urine output, CPB duration and surgical variables. The concept of individualized hemodynamic management using patient's baseline cardiac index in high-risk abdominal surgical patients had demonstrated to reduce postoperative complications [26]. And It is the authors' belief, that identifying individualized targets was a key component of impacting patient improvement and supported the high compliance of GDT protocol adoption.…”

Pulse Wave Analysis to Estimate Cardiac Output

“…51 In this regard, noninvasive pulse wave analysis systems enable clinicians to determine baseline CO before surgery (e.g., the day before surgery on the ward). In the Targeting Preoperatively Assessed Personal Cardiac Index in Major Abdominal Surgery Patients (TAPIR) trial, 52 noninvasive pulse wave analysis (CNAP system) was used to determine the individual patient's baseline cardiac index the day before surgery. In patients assigned to personalized management, clinicians strove to maintain this baseline cardiac index during surgery-where cardiac index was measured using minimally invasive internally calibrated pulse wave analysis (ProAQT/ Pulsioflex system)-by using fluids and dobutamine based on a goal-directed therapy algorithm.…”