Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial.

Importance: It is not known if use of colloid solutions containing hydroxyethyl starch (HES) to correct for intravascular deficits in high-risk surgical patients is either effective or safe. Objective: To evaluate the effect of HES 130/0.4 compared with 0.9% saline for intravascular volume expansion on mortality and postoperative complications after major abdominal surgery. Design, Setting, and Participants: Multicenter, double-blind, parallel-group, randomized clinical trial of 775 adult patients at increased risk of postoperative kidney injury undergoing major abdominal surgery at 20 university hospitals in France from February 2016 to July 2018; final follow-up was in October 2018. Interventions: Patients were randomized to receive fluid containing either 6% HES 130/0.4 diluted in 0.9% saline (n = 389) or 0.9% saline alone (n = 386) in 250-mL boluses using an individualized hemodynamic algorithm during surgery and for up to 24 hours on the first postoperative day, defined as ending at 7:59 am the following day. Main Outcomes and Measures: The primary outcome was a composite of death or major postoperative complications at 14 days after surgery. Secondary outcomes included predefined postoperative complications within 14 days after surgery, durations of intensive care unit and hospital stays, and all-cause mortality at postoperative days 28 and 90. Results: Among 826 patients enrolled (mean age, 68 [SD, 7] years; 91 women [12%]), 775 (94%) completed the trial. The primary outcome occurred in 139 of 389 patients (36%) in the HES group and 125 of 386 patients (32%) in the saline group (difference, 3.3% [95% CI, -3.3% to 10.0%]; relative risk, 1.10 [95% CI, 0.91-1.34]; P = .33). Among 12 prespecified secondary outcomes reported, 11 showed no significant difference, but a statistically significant difference was found in median volume of study fluid administered on day 1: 1250 mL (interquartile range, 750-2000 mL) in the HES group and 1500 mL (interquartile range, 750-2150 mL) in the saline group (median difference, 250 mL [95% CI, 83-417 mL]; P = .006). At 28 days after surgery, 4.1% and 2.3% of patients had died in the HES and saline groups, respectively (difference, 1.8% [95% CI, -0.7% to 4.3%]; relative risk, 1.76 [95% CI, 0.79-3.94]; P = .17). Conclusions and Relevance: Among patients at risk of postoperative kidney injury undergoing major abdominal surgery, use of HES for volume replacement therapy compared with 0.9% saline resulted in no significant difference in a composite outcome of death or major postoperative complications within 14 days after surgery. These findings do not support the use of HES for volume replacement therapy in such patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02502773.

Positive end-expiratory pressure does not decrease cardiac output during laparoscopic liver surgery: A prospective observational evaluation.

BACKGROUND: Positive end-expiratory pressure (PEEP) has beneficial pulmonary effects but may worsen the hemodynamic repercussions induced by pneumoperitoneum (PNP) in patients undergoing laparoscopic liver resection. However, by increasing intraluminal vena cava (VC) pressures, PEEP may prevent PNP-induced VC collapse. The aim of this study was to test the validity of this hypothesis. METHODS: After IRB approval and written informed consent, 20 patients were evaluated prospectively. Measurements were performed before and after the application of 10 cmH2O PEEP on patients without PNP (Control group) and during a 12 cmH20 PNP. Results are provided as means [95%CI]. Comparison used paired-sample t test. RESULTS: PEEP induced a decrease in CI in Control subgroup (2.3 [2.0-2.6] and 2.1 [1.8-2.4] l min-1 m-2 before and after PEEP. P < 0.05). In contrast, PEEP on a pre-established PNP did not significantly modify cardiac index (CI). Transmural pressure on the abdominal vena cava decreased with PNP but was partly reversed by the addition of PEEP. CONCLUSION: The application of PEEP on a pre-established PNP during laparoscopic liver resection in normovolemic patients did not decrease CI. Analysis of transmural VC pressure variations confirms that the addition of PEEP may prevent the vena caval collapse induced by PNP.