Association between Type of Fluid Received Prior to Enrollment, Type of Admission, and Effect of Balanced Crystalloid in Critically Ill Adults : A Secondary Exploratory Analysis of the BaSICS Clinical Trial
Rationale: The effects of balanced crystalloid versus saline on clinical outcomes for ICU patients may be modified by the type of fluid that patients received for initial resuscitation and by the type of admission. Objectives: To assess whether the results of a randomized controlled trial could be affected by fluid use before enrollment and admission type. Methods: Secondary post hoc analysis of the BaSICS (Balanced Solution in Intensive Care Study) trial, which compared a balanced solution (Plasma-Lyte 148) with 0.9% saline in the ICU. Patients were categorized according to fluid use in the 24 hours before enrollment in four groups (balanced solutions only, 0.9% saline only, a mix of both, and no fluid before enrollment) and according to admission type (planned, unplanned with sepsis, and unplanned without sepsis). The association between 90-day mortality and the randomization group was assessed using a hierarchical logistic Bayesian model. Measurements and Main Results: A total of 10,520 patients were included. There was a low probability that the balanced solution was associated with improved 90-day mortality in the whole trial population (odds ratio [OR], 0.95; 89% credible interval [CrI], 0.66-10.51; probability of benefit, 0.58); however, probability of benefit was high for patients who received only balanced solutions before enrollment (regardless of admission type, OR, 0.78; 89% CrI, 0.56-1.03; probability of benefit, 0.92), mostly because of a benefit in unplanned admissions due to sepsis (OR, 0.70; 89% CrI, 0.50-0.97; probability of benefit, 0.96) and planned admissions (OR, 0.79; 89% CrI, 0.65-0.97; probability of benefit, 0.97). Conclusions: There is a high probability that balanced solution use in the ICU reduces 90-day mortality in patients who exclusively received balanced fluids before trial enrollment. Clinical trial registered with www.clinicaltrials.gov (NCT02875873).
| Errataetall: |
CommentIn: Am J Respir Crit Care Med. 2022 Jun 15;205(12):1372-1374. - PMID 35486860 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:205 |
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| Enthalten in: |
American journal of respiratory and critical care medicine - 205(2022), 12 vom: 15. Juni, Seite 1419-1428 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zampieri, Fernando G [VerfasserIn] |
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| Links: |
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| Themen: |
Balanced solutions |
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| Anmerkungen: |
Date Completed 17.06.2022 Date Revised 12.03.2023 published: Print ClinicalTrials.gov: NCT02875873 CommentIn: Am J Respir Crit Care Med. 2022 Jun 15;205(12):1372-1374. - PMID 35486860 Citation Status MEDLINE |
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| doi: |
10.1164/rccm.202111-2484OC |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM338794832 |
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| 100 | 1 | |a Zampieri, Fernando G |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Association between Type of Fluid Received Prior to Enrollment, Type of Admission, and Effect of Balanced Crystalloid in Critically Ill Adults |b A Secondary Exploratory Analysis of the BaSICS Clinical Trial |
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| 500 | |a Date Completed 17.06.2022 | ||
| 500 | |a Date Revised 12.03.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT02875873 | ||
| 500 | |a CommentIn: Am J Respir Crit Care Med. 2022 Jun 15;205(12):1372-1374. - PMID 35486860 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Rationale: The effects of balanced crystalloid versus saline on clinical outcomes for ICU patients may be modified by the type of fluid that patients received for initial resuscitation and by the type of admission. Objectives: To assess whether the results of a randomized controlled trial could be affected by fluid use before enrollment and admission type. Methods: Secondary post hoc analysis of the BaSICS (Balanced Solution in Intensive Care Study) trial, which compared a balanced solution (Plasma-Lyte 148) with 0.9% saline in the ICU. Patients were categorized according to fluid use in the 24 hours before enrollment in four groups (balanced solutions only, 0.9% saline only, a mix of both, and no fluid before enrollment) and according to admission type (planned, unplanned with sepsis, and unplanned without sepsis). The association between 90-day mortality and the randomization group was assessed using a hierarchical logistic Bayesian model. Measurements and Main Results: A total of 10,520 patients were included. There was a low probability that the balanced solution was associated with improved 90-day mortality in the whole trial population (odds ratio [OR], 0.95; 89% credible interval [CrI], 0.66-10.51; probability of benefit, 0.58); however, probability of benefit was high for patients who received only balanced solutions before enrollment (regardless of admission type, OR, 0.78; 89% CrI, 0.56-1.03; probability of benefit, 0.92), mostly because of a benefit in unplanned admissions due to sepsis (OR, 0.70; 89% CrI, 0.50-0.97; probability of benefit, 0.96) and planned admissions (OR, 0.79; 89% CrI, 0.65-0.97; probability of benefit, 0.97). Conclusions: There is a high probability that balanced solution use in the ICU reduces 90-day mortality in patients who exclusively received balanced fluids before trial enrollment. Clinical trial registered with www.clinicaltrials.gov (NCT02875873) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a balanced solutions | |
| 650 | 4 | |a critical care | |
| 650 | 4 | |a fluid challenge | |
| 650 | 7 | |a Crystalloid Solutions |2 NLM | |
| 650 | 7 | |a Saline Solution |2 NLM | |
| 700 | 1 | |a Machado, Flávia R |e verfasserin |4 aut | |
| 700 | 1 | |a Biondi, Rodrigo S |e verfasserin |4 aut | |
| 700 | 1 | |a Freitas, Flávio G R |e verfasserin |4 aut | |
| 700 | 1 | |a Veiga, Viviane C |e verfasserin |4 aut | |
| 700 | 1 | |a Figueiredo, Rodrigo C |e verfasserin |4 aut | |
| 700 | 1 | |a Lovato, Wilson J |e verfasserin |4 aut | |
| 700 | 1 | |a Amêndola, Cristina P |e verfasserin |4 aut | |
| 700 | 1 | |a Serpa-Neto, Ary |e verfasserin |4 aut | |
| 700 | 1 | |a Paranhos, Jorge L R |e verfasserin |4 aut | |
| 700 | 1 | |a Lúcio, Eraldo A |e verfasserin |4 aut | |
| 700 | 1 | |a Oliveira-Júnior, Lúcio C |e verfasserin |4 aut | |
| 700 | 1 | |a Lisboa, Thiago C |e verfasserin |4 aut | |
| 700 | 1 | |a Lacerda, Fábio H |e verfasserin |4 aut | |
| 700 | 1 | |a Maia, Israel S |e verfasserin |4 aut | |
| 700 | 1 | |a Grion, Cintia M C |e verfasserin |4 aut | |
| 700 | 1 | |a Assunção, Murillo S C |e verfasserin |4 aut | |
| 700 | 1 | |a Manoel, Airton L O |e verfasserin |4 aut | |
| 700 | 1 | |a Corrêa, Thiago D |e verfasserin |4 aut | |
| 700 | 1 | |a Guedes, Marco Antonio V A |e verfasserin |4 aut | |
| 700 | 1 | |a Azevedo, Luciano C P |e verfasserin |4 aut | |
| 700 | 1 | |a Miranda, Tamiris A |e verfasserin |4 aut | |
| 700 | 1 | |a Damiani, Lucas P |e verfasserin |4 aut | |
| 700 | 1 | |a Brandão da Silva, Nilton |e verfasserin |4 aut | |
| 700 | 1 | |a Cavalcanti, Alexandre B |e verfasserin |4 aut | |
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