Dataset Information

Statistical analysis plan for the Balanced Solution versus Saline in Intensive Care Study (BaSICS).

ABSTRACT:

Objective

To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS).

Methods

BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure.

Results

BaSICS will have 90-day mortality as its primary endpoint, which will be tested using mixed-effects Cox proportional hazard models, considering sites as a random variable (frailty models) adjusted for age, organ dysfunction and admission type. Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days.

Conclusion

This manuscript provides details on the first version of the statistical analysis plan for the BaSICS trial and will guide the study's analysis when follow-up is finished.

SUBMITTER: Damiani LP

PROVIDER: S-EPMC7853670 | biostudies-literature | 2020 Oct-Dec

REPOSITORIES: biostudies-literature

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Publications

Statistical analysis plan for the Balanced Solution versus Saline in Intensive Care Study (BaSICS).

Damiani Lucas Petri LP Cavalcanti Alexandre Biasi AB Biondi Rodrigo Santos RS Freitas Flávio Geraldo Rezende de FGR Figueiredo Rodrigo Cruvinel RC Lovato Wilson José WJ Amêndola Cristina Prata CP Serpa Neto Ary A Paranhos Jorge Luiz da Rocha JLDR Veiga Viviane Cordeiro VC Guedes Marco Antonio Vieira MAV Lúcio Eraldo de Azevedo EA Oliveira Júnior Lúcio Couto LC Lisboa Thiago Costa TC Lacerda Fabio Holanda FH Miranda Tamiris Abait TA Maia Israel Silva IS Grion Cintia Magalhães Carvalho CMC Machado Flavia Ribeiro FR Zampieri Fernando Godinho FG

Revista Brasileira de terapia intensiva 20201001 4

<h4>Objective</h4>To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS).<h4>Methods</h4>BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will ...[more]

PMID: 33263702

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Project description:BackgroundIntravenous fluid therapy is important for pediatric and adult patients in intensive care units (ICUs). However, medical professionals continue to struggle to determine the most appropriate fluids to obtain the best possible outcomes for each patient.ObjectiveWe conducted a meta-analysis involving cohort studies and randomized controlled trials (RCTs) to compare the influence of balanced crystalloid solutions and normal saline among patients in ICUs.Patients and methodsStudies that compared balanced crystalloid solutions and saline in ICU patients from databases including PubMed, Embase, Web of Science, and Cochrane Library were systematically searched up to July 25, 2022. The primary outcomes were mortality and renal-related outcomes, which included major adverse kidney events within 30 days (MAKE30), acute kidney injury (AKI), new receipt of renal replacement therapy (RRT), maximum creatinine increasing, maximum creatinine level, and final creatinine level ≥ 200% of baseline. Service utilization including length of hospital stay, ICU stay, ICU-free days and ventilator-free days were also reported.ResultsA total of 13 studies (10 RCTs and 3 cohort studies) involving 38,798 patients in ICUs met the selection criteria. Our analysis revealed that each subgroup had no significant difference in mortality outcomes among ICU patients between balanced crystalloid solutions and normal saline. A significant difference was detected between the adult groups (odds ratio [OR], 0.92; 95% confidence interval [CI], [0.86, 1.00]; p = 0.04) indicating that the AKI in the balanced crystalloid solutions group was lower than that in the normal saline group. Other renal-related outcomes, such as MAKE30, RRT, maximum creatinine increasing, maximum creatinine level, and final creatinine level ≥ 200% of baseline showed no significant difference between the two groups. Regarding secondary outcomes, the balanced crystalloid solution group had a longer ICU stay time (WMD, 0.02; 95% CI, [0.01, 0.03]; p = 0.0004 and I2 = 0%; p = 0.96) than the normal saline group among adult patients. Furthermore, children treated with balanced crystalloid solution had a shorter hospital stay time (WMD, - 1.10; 95% CI, [- 2.10, - 0.10]; p = 0.03 and I2 = 17%; p = 0.30) than those treated with saline.ConclusionsCompared with saline, balanced crystalloid solutions could not reduce the risk of mortality and renal-related outcomes, including MAKE30, RRT, maximum creatinine increasing, maximum creatinine level, and final creatinine level ≥ 200% of baseline, but the solutions may reduce total AKI incidence among adult patients in ICUs. For service utilization outcomes, balanced crystalloid solutions were associated with a longer length of ICU stay in the adult group and shorter length of hospital stay in the pediatric group.

Project description:BackgroundSaline, the intravenous fluid most commonly administered to critically ill adults, contains a high chloride content, which may be associated with acute kidney injury and death. Whether using balanced crystalloids rather than saline decreases the risk of acute kidney injury and death among critically ill adults remains unknown.MethodsThe Isotonic Solutions and Major Adverse Renal Events Trial (SMART) is a pragmatic, cluster-level allocation, cluster-level crossover trial being conducted between 1 June 2015 and 30 April 2017 in five intensive care units at Vanderbilt University Medical Center in Nashville, TN, USA. SMART compares saline (0.9% sodium chloride) with balanced crystalloids (clinician's choice of lactated Ringer's solution or Plasma-Lyte A®). Each intensive care unit is assigned to provide either saline or balanced crystalloids each month, with the assigned crystalloid alternating monthly over the course of the trial. All adults admitted to participating intensive care units during the study period are enrolled and followed until hospital discharge or 30 days after enrollment. The anticipated enrollment is approximately 14,000 patients. The primary outcome is Major Adverse Kidney Events within 30 days-the composite of in-hospital death, receipt of new renal replacement therapy, or persistent renal dysfunction (discharge creatinine ≥200% of baseline creatinine). Secondary clinical outcomes include in-hospital mortality, intensive care unit-free days, ventilator-free days, vasopressor-free days, and renal replacement therapy-free days. Secondary renal outcomes include new renal replacement therapy receipt, persistent renal dysfunction, and incidence of stage 2 or higher acute kidney injury.DiscussionThis ongoing pragmatic trial will provide the largest and most comprehensive comparison to date of clinical outcomes with saline versus balanced crystalloids among critically ill adults.Trial registrationFor logistical reasons, SMART was prospectively registered separately for the medical ICU (SMART-MED; ClinicalTrials.gov identifier: NCT02444988 ; registered on 11 May 2015; date of first patient enrollment: 1 June 2015) and the nonmedical ICUs (SMART-SURG; ClinicalTrials.gov identifier: NCT02547779 ; registered on 9 September 2015; date of first patient enrollment: 1 October 2015).

Project description:Intravenous fluids are used for almost all intensive care unit (ICU) patients. Clinical and laboratory studies have questioned whether specific fluid types result in improved outcomes, including mortality and acute kidney injury. To determine the effect of a balanced solution vs saline solution (0.9% sodium chloride) on 90-day survival in critically ill patients. Double-blind, factorial, randomized clinical trial conducted at 75 ICUs in Brazil. Patients who were admitted to the ICU with at least 1 risk factor for worse outcomes, who required at least 1 fluid expansion, and who were expected to remain in the ICU for more than 24 hours were randomized between May 29, 2017, and March 2, 2020; follow-up concluded on October 29, 2020. Patients were randomized to 2 different fluid types (a balanced solution vs saline solution reported in this article) and 2 different infusion rates (reported separately). Patients were randomly assigned 1:1 to receive either a balanced solution (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids. The primary outcome was 90-day survival. Among 11 052 patients who were randomized, 10 520 (95.2%) were available for the analysis (mean age, 61.1 [SD, 17] years; 44.2% were women). There was no significant interaction between the 2 interventions (fluid type and infusion speed; P = .98). Planned surgical admissions represented 48.4% of all patients. Of all the patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment. Patients in both groups received a median of 1.5 L of fluid during the first day after enrollment. By day 90, 1381 of 5230 patients (26.4%) assigned to a balanced solution died vs 1439 of 5290 patients (27.2%) assigned to saline solution (adjusted hazard ratio, 0.97 [95% CI, 0.90-1.05]; P = .47). There were no unexpected treatment-related severe adverse events in either group. Among critically ill patients requiring fluid challenges, use of a balanced solution compared with 0.9% saline solution did not significantly reduce 90-day mortality. The findings do not support the use of this balanced solution. ClinicalTrials.gov Identifier: NCT02875873.

Project description:BackgroundComparative clinical effects of balanced crystalloids and saline are uncertain, particularly in noncritically ill patients cared for outside an intensive care unit (ICU).MethodsWe conducted a single-center, pragmatic, multiple-crossover trial comparing balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A) with saline among adults who were treated with intravenous crystalloids in the emergency department and were subsequently hospitalized outside an ICU. The type of crystalloid that was administered in the emergency department was assigned to each patient on the basis of calendar month, with the entire emergency department crossing over between balanced crystalloids and saline monthly during the 16-month trial. The primary outcome was hospital-free days (days alive after discharge before day 28). Secondary outcomes included major adverse kidney events within 30 days - a composite of death from any cause, new renal-replacement therapy, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline) - all censored at hospital discharge or 30 days, whichever occurred first.ResultsA total of 13,347 patients were enrolled, with a median crystalloid volume administered in the emergency department of 1079 ml and 88.3% of the patients exclusively receiving the assigned crystalloid. The number of hospital-free days did not differ between the balanced-crystalloids and saline groups (median, 25 days in each group; adjusted odds ratio with balanced crystalloids, 0.98; 95% confidence interval [CI], 0.92 to 1.04; P=0.41). Balanced crystalloids resulted in a lower incidence of major adverse kidney events within 30 days than saline (4.7% vs. 5.6%; adjusted odds ratio, 0.82; 95% CI, 0.70 to 0.95; P=0.01).ConclusionsAmong noncritically ill adults treated with intravenous fluids in the emergency department, there was no difference in hospital-free days between treatment with balanced crystalloids and treatment with saline. (Funded by the Vanderbilt Institute for Clinical and Translational Research and others; SALT-ED ClinicalTrials.gov number, NCT02614040 .).

Dataset Information

Statistical analysis plan for the Balanced Solution versus Saline in Intensive Care Study (BaSICS).

Objective

Methods

Results

Conclusion

Publications

Statistical analysis plan for the Balanced Solution versus Saline in Intensive Care Study (BaSICS).

Similar Datasets

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