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  • 2020 Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery. JAMA, 323(3), 225 _ 10.1001_jama.2019.20833

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    2020 Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery. JAMA, 323(3), 225 _ 10.1001_jama.2019.20833

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    JAMA | Original investigation 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 manuel Fut, MD, PO, Matthias att, MD; Thomas Gadet, MD, PhO; Matthieu Bas, MO, PhD; Oa eral, MO, Alexandre Ouatara, MO PhO, Divir Huet, MD Ph; Thomas Lesot, MD. PhDs Giles Lebufe MD, Ph; Anteine Det, MD, Ph; Ann Cadi, MD; AymaricRestoux MD, PRD; Karim Asehoune, MO, PhO: Catherine Paugam Butz MO. Ph: Philippe Cullen. MD PhO: Marion Faucher. MO, PhD: Caml ase. MO. ‘YouresEl Amine, HO, Hele Bele MO, PAO: Marc Leone, MO, PHO: Er No MD, PhO; Vincent Pou, MD, PhO: Sigsenand Lack, MD, PRO: Jean Etienne Bazin. MO, PRO: Bruno ere, PRO: Samir faber, MO, PRD: fr the FLASH Tl Group Visual Abstract IMPORTANCE itisnotknowm fuse of collid solutions contaninghycronyettytstarch(HES) px ear poge 27 toconect for intravascular deficits in high-sk surgical patients ether effective or sae. ‘OBJECTIVE To evaluate the effect of HES 130/0.4 compared with 0.9% sain for intravascular volume expansion on mortality and postoperative complications after major abdominal surgery. DESIGN, SETTING, AND PARTICIPANTS Multicenter, double-blind, parallel-group, randomized linia til of 775 adult patients at increased rik of postoperative kidney injury undergoing ‘major abdominal surgery at 20 university hospitals in France from February 2016 to July 2018; final follow up wasin October 2078, INTERVENTIONS Patents were randomized to receive Nuld contaling ether 6% HES 120/04 dilute in 0.9% saline (n = 389) oF 0.9% saline alone (n = 386) in 250-ml. boluses using an individualized hemodynamic algorithm during surgery and for upto 24 hours on the fist postoperative day, defined as ending at 7:9 au the fllowing day. Supplemental content "MAIN OUTCOMES AND MEASURES The primary outcome was composite of death or major Postoperative complications a 4 days after surgery. Secondary outcomes included predefined postoperative complications within ¥4 days after surgery, durations of intensive ‘areunit and hospital stays, and all-cause mortality at postoperative days 28 and 80. RESULTS Among 826 patients enrolled (mean age, 68 [SD 7] years: 91 women {12%), 775. (9496) completed the tra. The primary outcome occured in 139 of 389 patients (36% nthe HES group and 125 of 386 patients (32%) in the saline group (flrence, 3336 [95% I, 33% 10 10.0% relative rik, 110 95% CI, 091134]; P= 33). Among 2 prespecified secondary outcomes reported 1 showed no significant ference, but a statistically significant eifference was found in median volume of study fd administered on day 1250 mL (interquartile range, 750-2000 mi) in the HES group and 1500 mi (interquartile range, 50-2150 mi) in the saline group (median cifference, 250 mL [95% Cl, 83-417 mL: P=.006).At28 days after surgery, 4.1% and 2.3% of patientshad dledin the HES and saline .r0Ups. respectively (lifference, 189 [95% Cl, ~0.7% to 4.3%]: relative risk, 176 [95% Cl 079.394); 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% sane resulted no significant ifference na composite outcome of death or ‘thor eins thor major postoperative complcatons within day aftr surgry These ining 0% ‘creneteedactherdothe Suppor the se of HES for volume replacement hrapyinsuh patients. =e "MIAL REAISTRATION Gia gov enti: NCTO2502773 rsh cpm pes theondofthe sre, Corresponding Author: Eman Fur MO, Po. Ogparterartde Medecine Perepeatare Anesthése Résnmation Pace Lie Abe 163003 Clermont Ferrand ese France tute ec {na.2020.330).25 236 dob10100\jame201920833 ermerterand © 2020 American Medical Association. llrightsreserved. Downloaded From: httpsi//jamanetwork.com/ by a Columbia University Libraries User on 01/21/2020 esearch Orgallnvesgation ‘dministation of intravenous uid therapy is critical aspect of maintaining fuid balance during surgery and ‘can result in perioperative complications iftoo much or too little given. During surgery, extracellular fuld vol- ‘ume is maintained by giving continuous infusions of intrave ‘nous fluids. When hypovolemia occurs, fluid bolusesaregiven, torestore intravascular volume.” Itis not known fits better to.use colloid or crystalloid solutions to cortect for intravas- cular volume deficit that occur during surgery. Hydroxyetiy starches (HES) are semisynthetic colloid so lutions that have been used for uid replacement therapy in patients undergoing major surgery* because of their hypo- thetleal ability to provide faster hemodynamic stabilization > 1 ce Gandini ern {08 tndonindioeceveioneth Sensis 19 Denote sy fad Psp rset Tamales {9 Hanintedo ecehe 09 abe yt second 22 Dianerecove sway fd Siuthren coset Seege att Ieee eco 5 Soran cteed 1 Bede Ganordin era 39 cul wen to ve as 19 Clue ne reves i) 1 teued Garey wn Nee recht hd 283 fetdein epoca rt 2 ried Gay ti intraoperative clinical variables were not imputed. With the exception of components of the composite primary out- come, no adjustment was made for multiple comparisons. Because of the potential for type I error due to multiple comparisons, findings for analyses of secondary end points should be interpreted as exploratory. ‘A post hoc subgroup analysis was performed to test fora differencein treatment effect within patients with kidney dys- function as defined by preoperative serum creatinine level greater than L.2:mg/aL (yes vsno) at randomization. P values {or interaction were derived from the multivariable random effect logistic regression modelincludingtreatmentand anin- teraction term. ‘ll analyses were conducted using Stata software, ver- sion 13,0 (StataCorp), using the gllamm module. A 2-sided «05 was considered to indicate statistical significance. 228 MMA Jansry22020 vume323 Numbers 6 een et ue as “Stuy rudnot vate ares ofdspensng are seit iin efit dota ‘entctingonging vestigations

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