Extended goal-directed fluid therapy shows no benefit for complications after esophagectomy in single-center trial
In a single-center, single-blind randomized controlled trial, 100 patients undergoing esophagectomy for esophageal cancer were assigned to receive either extended goal-directed fluid therapy or standard care. The intervention was individualized based on the patient's nighttime baseline cardiac output and mean arterial pressure thresholds and administered from tracheal intubation through to 7:00 am the following morning. The primary outcome was total postoperative morbidity measured by the Comprehensive Complication Index (CCI) at day 30.
The study found no difference in the primary outcome between groups (mean CCI: 39.0 ± 20.0 in the intervention group vs. 39.2 ± 21.0 in the standard group; mean difference -0.2, 95% CI -8.6 to 8.1, P = 0.95). Protocol adherence was demonstrated, with the intervention group having a higher mean fluid balance (mean difference 516 ml, 95% CI 57 to 974, P = 0.028), increased norepinephrine use (median 7,894 µg vs. 4,611 µg, P < 0.001), and a higher mean arterial pressure (mean difference 3 mmHg, 95% CI 1 to 5, P = 0.011).
Safety and tolerability data were not reported. Key limitations include the single-center design and small sample size of 100 patients. The study's practice relevance is restrained; while the protocol achieved its physiological targets, it did not translate to a reduction in postoperative complications. Funding and conflicts of interest were not reported.