METHODS: Prospective, randomized, parallel group, noninferiority clinical trial.
METHODS: Single center, 42-bed state trauma, medical and surgical ICUs, from April 20, 2022, to July 1, 2022.
METHODS: Patients with serum phosphate concentration between 0.3 and 0.75 mmol/L.
METHODS: We randomized patients to either enteral or IV phosphate replacement using electronic medical record-embedded program.
RESULTS: Our primary outcome was serum phosphate at 24 hours with a noninferiority margin of 0.2 mmol/L. Secondary outcomes included cost savings and environmental waste reduction and additional IV fluid administered. The modified intention-to-treat cohort comprised 131 patients. Baseline phosphate concentrations were similar between the two groups. At 24 hours, mean ( sd ) serum phosphate concentration were enteral 0.89 mmol/L (0.24 mmol/L) and IV 0.82 mmol/L (0.28 mmol/L). This difference was noninferior at the margin of 0.2 mmol/L (difference, 0.07 mmol/L; 95% CI, -0.02 to 0.17 mmol/L). When assigned IV replacement, patients received 408 mL (372 mL) of solvent IV fluid. Compared with IV replacement, the mean cost per patient was ten-fold less with enteral replacement ($3.7 [$4.0] vs. IV: $37.7 [$31.4]; difference = $34.0 [95% CI, $26.3-$41.7]) and weight of waste was less (7.7 g [8.3 g] vs. 217 g [169 g]; difference = 209 g [95% CI, 168-250 g]). C O2 emissions were 60-fold less for comparable phosphate replacement (enteral: 2 g producing 14.2 g and 20 mmol of potassium dihydrogen phosphate producing 843 g of C O2 equivalents).
CONCLUSIONS: Enteral phosphate replacement in ICU is noninferior to IV replacement at a margin of 0.2 mmol/L but leads to a substantial reduction in cost and waste.
方法:前瞻性,随机化,平行组,非劣效性临床试验。
方法:单中心,42床状态创伤,医疗和外科ICU,从2022年4月20日至2022年7月1日。
方法:患者血清磷酸盐浓度在0.3-0.75mmol/L之间
方法:我们使用嵌入电子病历的程序,将患者随机分为肠内或静脉内磷酸盐替代。
结果:我们的主要结果是24小时的血清磷酸盐,非劣效性为0.2mmol/L。次要结果包括成本节约和环境废物减少以及额外的静脉输液管理。改良的意向治疗队列包括131名患者。两组之间的基线磷酸盐浓度相似。24小时后,平均(sd)血清磷酸盐浓度为肠内0.89mmol/L(0.24mmol/L)和静脉0.82mmol/L(0.28mmol/L)。这一差异在0.2mmol/L的边缘不差(差异,0.07mmol/L;95%CI,-0.02至0.17mmol/L)。当分配IV替换时,患者接受408mL(372mL)溶剂IV液.与IV替换相比,肠内替代治疗每位患者的平均费用减少了十倍(3.7美元[4.0美元]与IV:37.7美元[31.4美元];差异=34.0美元[95%CI,26.3-41.7美元]),废物重量较少(7.7克[8.3克]与217克[169克];差异=209克[95%CI,168-250克])。对于可比的磷酸盐替代(肠内:2g产生14.2g和20mmol磷酸二氢钾产生843gCO2当量),CO2排放量减少了60倍。
结论:在0.2mmol/L的范围内,ICU中的肠内磷酸盐替代不劣于静脉内替代,但成本和浪费显着降低。