Effect of Hydroxyethyl Starch vs Saline ...
Type de document :
Article dans une revue scientifique: Article original
DOI :
PMID :
URL permanente :
Titre :
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.
Auteur(s) :
Futier, Emmanuel [Auteur]
Service d'Anésthésie Réanimation [CHU Clermont-Ferrand]
Garot, Matthias [Auteur]
Hôpital Claude Huriez [Lille]
Godet, Thomas [Auteur]
Service d'Anésthésie Réanimation [CHU Clermont-Ferrand]
Biais, Matthieu [Auteur]
Service Anesthésie - Réanimation [Bordeaux]
Verzilli, Daniel [Auteur]
Département d'anesthésie-réanimation[Montpellier]
Ouattara, Alexandre [Auteur]
Service Anesthésie - Réanimation [Bordeaux]
Huet, Olivier [Auteur]
CHRU Brest - Département d'Anesthésie Réanimation [CHU - BREST - DAR]
Lescot, Thomas [Auteur]
Fresenius Kabi, Paris, France
Lebuffe, Gilles [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Dewitte, A. [Auteur]
Cadic, A. [Auteur]
Restoux, A. [Auteur]
Asehnoune, K. [Auteur]
Paugam-Burtz, C. [Auteur]
Cuvillon, P. [Auteur]
Faucher, M. [Auteur]
Vaisse, C. [Auteur]
El Amine, Y. [Auteur]
Beloeil, H. [Auteur]
Leone, M. [Auteur]
Noll, E. [Auteur]
Piriou, V. [Auteur]
Lasocki, S. [Auteur]
Bazin, J. E. [Auteur]
Pereira, B. [Auteur]
Jaber, S. [Auteur]
Service d'Anésthésie Réanimation [CHU Clermont-Ferrand]
Garot, Matthias [Auteur]
Hôpital Claude Huriez [Lille]
Godet, Thomas [Auteur]
Service d'Anésthésie Réanimation [CHU Clermont-Ferrand]
Biais, Matthieu [Auteur]
Service Anesthésie - Réanimation [Bordeaux]
Verzilli, Daniel [Auteur]
Département d'anesthésie-réanimation[Montpellier]
Ouattara, Alexandre [Auteur]
Service Anesthésie - Réanimation [Bordeaux]
Huet, Olivier [Auteur]
CHRU Brest - Département d'Anesthésie Réanimation [CHU - BREST - DAR]
Lescot, Thomas [Auteur]
Fresenius Kabi, Paris, France
Lebuffe, Gilles [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Dewitte, A. [Auteur]
Cadic, A. [Auteur]
Restoux, A. [Auteur]
Asehnoune, K. [Auteur]
Paugam-Burtz, C. [Auteur]
Cuvillon, P. [Auteur]
Faucher, M. [Auteur]
Vaisse, C. [Auteur]
El Amine, Y. [Auteur]
Beloeil, H. [Auteur]
Leone, M. [Auteur]
Noll, E. [Auteur]
Piriou, V. [Auteur]
Lasocki, S. [Auteur]
Bazin, J. E. [Auteur]
Pereira, B. [Auteur]
Jaber, S. [Auteur]
Titre de la revue :
JAMA
Numéro :
323
Pagination :
225-236
Date de publication :
2020-01-27
ISSN :
1538-3598
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
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 ...
Lire la suite >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.Lire moins >
Lire la suite >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.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
CHU Lille
CHU Lille
Collections :
Date de dépôt :
2023-05-25T03:42:28Z
2023-09-13T06:34:14Z
2024-04-23T07:52:35Z
2023-09-13T06:34:14Z
2024-04-23T07:52:35Z
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