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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.


ABSTRACT: 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.

SUBMITTER: Futier E 

PROVIDER: S-EPMC6990683 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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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.

Futier Emmanuel E   Garot Matthias M   Godet Thomas T   Biais Matthieu M   Verzilli Daniel D   Ouattara Alexandre A   Huet Olivier O   Lescot Thomas T   Lebuffe Gilles G   Dewitte Antoine A   Cadic Anna A   Restoux Aymeric A   Asehnoune Karim K   Paugam-Burtz Catherine C   Cuvillon Philippe P   Faucher Marion M   Vaisse Camille C   El Amine Younes Y   Beloeil Hélène H   Leone Marc M   Noll Eric E   Piriou Vincent V   Lasocki Sigismond S   Bazin Jean-Etienne JE   Pereira Bruno B   Jaber Samir S   Lasocki Sigismond   Huet Olivier   Cadic Anna   Jacob Christophe   Paugam-Burtz Catherine   Restoux Aymeric   Ouattara Alexandre   Feitita Ioana   Deloge Elsa   Defaye Mylène   Joannes-Boyau Olivier   Carles Pauline   Napolitano Guya   Monziols Simon   Futier Emmanuel   Vignaud Marie   Paul Solène   Gahbiche Karim   Fayon Julie   Laroche Erwan   Bazin Jean-Etienne   Brandely Antoine   Le Moal Charlene   Lebuffe Gilles   Garot Matthias   Piriou Vincent   Jaber Samir   Chanques Gérald   Verzilli Daniel   De Jong Audrey   Millot Alice   Castagnoli Anna   Leone Marc   Pastene Bruno   Castelli Caroline   Medam Sophie   Velly Lionel   Vaisse Camille   Faucher Marion   Asehnoune Karim   Samba Esther   Roquilly Antoine   Le Penndu Marguerite   Cuvillon Philippe   Yves Lefrant Jean   Wira Olivier   Dubout Elisabeth   Mfam Willy-Serge   Lescot Thomas   Begneu Emilie   Burey Julien   Cirilovic Teodora   Beloeil Hélène   Allo Guillaume   Pottecher Julien   Lebas Benjamin   Venot Clementine   Rameau Jean Pierre   Dimache Florin   Léger Pierre Saint   El Amine Younes  

JAMA 20200101 3


<h4>Importance</h4>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.<h4>Objective</h4>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.<h4>Design, setting, and participants</h4>Multicenter, double-blind, parallel-group, randomized clinical trial  ...[more]

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