Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock-Bayesian analyses of the CLASSIC trial

P. Sivapalan, TS. Meyhoff, PB. Hjortrup, T. Lange, BS. Kaas-Hansen, MN. Kjaer, JH. Laake, M. Cronhjort, SM. Jakob, M. Cecconi, M. Nalos, M. Ostermann, MLNG. Malbrain, MH. Møller, A. Perner, A. Granholm

. 2024 ; 68 (2) : 236-246. [pub] 20231023

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc24007427

Grantová podpora
Laege Sophus Carl Emil Friis og hustru Olga Doris Friis' Legat
NNF17OC0028608 Novo Nordisk Fonden
Rigshospitalet

BACKGROUND: The CLASSIC trial assessed the effects of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock. This pre-planned study provides a probabilistic interpretation and evaluates heterogeneity in treatment effects (HTE). METHODS: We analysed mortality, serious adverse events (SAEs), serious adverse reactions (SARs) and days alive without life-support within 90 days using Bayesian models with weakly informative priors. HTE on mortality was assessed according to five baseline variables: disease severity, vasopressor dose, lactate levels, creatinine values and IV fluid volumes given before randomisation. RESULTS: The absolute difference in mortality was 0.2%-points (95% credible interval: -5.0 to 5.4; 47% posterior probability of benefit [risk difference <0.0%-points]) with restrictive IV fluid. The posterior probabilities of benefits with restrictive IV fluid were 72% for SAEs, 52% for SARs and 61% for days alive without life-support. The posterior probabilities of no clinically important differences (absolute risk difference ≤2%-points) between the groups were 56% for mortality, 49% for SAEs, 90% for SARs and 38% for days alive without life-support. There was 97% probability of HTE for previous IV fluid volumes analysed continuously, that is, potentially relatively lower mortality of restrictive IV fluids with higher previous IV fluids. No substantial evidence of HTE was found in the other analyses. CONCLUSION: We could not rule out clinically important effects of restrictive IV fluid therapy on mortality, SAEs or days alive without life-support, but substantial effects on SARs were unlikely. IV fluids given before randomisation might interact with IV fluid strategy.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc24007427
003      
CZ-PrNML
005      
20240423155941.0
007      
ta
008      
240412s2024 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1111/aas.14345 $2 doi
035    __
$a (PubMed)37869991
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Sivapalan, Praleene $u Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark $u Deptartment of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $1 https://orcid.org/0000000204420032
245    10
$a Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock-Bayesian analyses of the CLASSIC trial / $c P. Sivapalan, TS. Meyhoff, PB. Hjortrup, T. Lange, BS. Kaas-Hansen, MN. Kjaer, JH. Laake, M. Cronhjort, SM. Jakob, M. Cecconi, M. Nalos, M. Ostermann, MLNG. Malbrain, MH. Møller, A. Perner, A. Granholm
520    9_
$a BACKGROUND: The CLASSIC trial assessed the effects of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock. This pre-planned study provides a probabilistic interpretation and evaluates heterogeneity in treatment effects (HTE). METHODS: We analysed mortality, serious adverse events (SAEs), serious adverse reactions (SARs) and days alive without life-support within 90 days using Bayesian models with weakly informative priors. HTE on mortality was assessed according to five baseline variables: disease severity, vasopressor dose, lactate levels, creatinine values and IV fluid volumes given before randomisation. RESULTS: The absolute difference in mortality was 0.2%-points (95% credible interval: -5.0 to 5.4; 47% posterior probability of benefit [risk difference <0.0%-points]) with restrictive IV fluid. The posterior probabilities of benefits with restrictive IV fluid were 72% for SAEs, 52% for SARs and 61% for days alive without life-support. The posterior probabilities of no clinically important differences (absolute risk difference ≤2%-points) between the groups were 56% for mortality, 49% for SAEs, 90% for SARs and 38% for days alive without life-support. There was 97% probability of HTE for previous IV fluid volumes analysed continuously, that is, potentially relatively lower mortality of restrictive IV fluids with higher previous IV fluids. No substantial evidence of HTE was found in the other analyses. CONCLUSION: We could not rule out clinically important effects of restrictive IV fluid therapy on mortality, SAEs or days alive without life-support, but substantial effects on SARs were unlikely. IV fluids given before randomisation might interact with IV fluid strategy.
650    _2
$a dospělí $7 D000328
650    _2
$a lidé $7 D006801
650    _2
$a Bayesova věta $7 D001499
650    _2
$a tekutinová terapie $7 D005440
650    _2
$a jednotky intenzivní péče $7 D007362
650    12
$a septický šok $x terapie $7 D012772
650    _2
$a randomizované kontrolované studie jako téma $7 D016032
655    _2
$a časopisecké články $7 D016428
700    1_
$a Meyhoff, Tine Sylvest $u Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $1 https://orcid.org/0000000218401596
700    1_
$a Hjortrup, Peter Buhl $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $u Department of Cardiothoracic Anaesthesia and Intensive Care, The Heart Center, Copenhagen University Hospital-Rigshospitalet Copenhagen, Copenhagen, Denmark $1 https://orcid.org/0000000238473247
700    1_
$a Lange, Theis $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $u Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark $1 https://orcid.org/0000000168078347
700    1_
$a Kaas-Hansen, Benjamin Skov $u Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $u Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark $1 https://orcid.org/0000000310230371
700    1_
$a Kjaer, Maj-Brit N $u Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark $u Deptartment of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $1 https://orcid.org/0000000265360504
700    1_
$a Laake, Jon Henrik $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $u Department of Intensive Care, Oslo University Hospital, Oslo, Norway $1 https://orcid.org/0000000161575359
700    1_
$a Cronhjort, Maria $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $u Department of Clinical sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden $1 https://orcid.org/0000000204448553
700    1_
$a Jakob, Stephan M $u University of Bern, Bern, Switzerland $1 https://orcid.org/0000000221950473
700    1_
$a Cecconi, Maurizio $u Biomedical Sciences Department, Humanitas University, Milan, Italy $u Department of Anaesthesia and Intensive Care, IRCCS-Humanitas Research Hospital, Milan, Italy $1 https://orcid.org/0000000243766538
700    1_
$a Nalos, Marek $u Department of Intensive Care, University Hospital Pilsen, Pilsen, Czech Republic $1 https://orcid.org/0000000279779410 $7 xx0078873
700    1_
$a Ostermann, Marlies $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $u Department of Intensive Care, Guy's and St Thomas' Hospital, London, UK $1 https://orcid.org/0000000195009080
700    1_
$a Malbrain, Manu L N G $u First Department of Anaesthesiology and Intensive Therapy, Medical University of Lublin, Lublin, Poland $1 https://orcid.org/0000000218165255
700    1_
$a Møller, Morten Hylander $u Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark $u Deptartment of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $1 https://orcid.org/0000000263789673
700    1_
$a Perner, Anders $u Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark $u Deptartment of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $1 https://orcid.org/0000000246680123
700    1_
$a Granholm, Anders $u Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark $u Deptartment of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark $u Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark $1 https://orcid.org/0000000157997655
773    0_
$w MED00000016 $t Acta anaesthesiologica Scandinavica $x 1399-6576 $g Roč. 68, č. 2 (2024), s. 236-246
856    41
$u https://pubmed.ncbi.nlm.nih.gov/37869991 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20240412 $b ABA008
991    __
$a 20240423155937 $b ABA008
999    __
$a ok $b bmc $g 2081419 $s 1217194
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2024 $b 68 $c 2 $d 236-246 $e 20231023 $i 1399-6576 $m Acta anaesthesiologica Scandinavica $n Acta Anaesthesiol Scand $x MED00000016
GRA    __
$p Laege Sophus Carl Emil Friis og hustru Olga Doris Friis' Legat
GRA    __
$a NNF17OC0028608 $p Novo Nordisk Fonden
GRA    __
$p Rigshospitalet
LZP    __
$a Pubmed-20240412

Najít záznam

Citační ukazatele

Možnosti archivace