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Balanced Crystalloid versus Saline in Adults with Traumatic Brain Injury: Secondary Analysis of a Clinical Trial.

ABSTRACT: Balanced crystalloids may improve outcomes compared with saline for some critically ill adults. Lower tonicity of balanced crystalloids could worsen cerebral edema in patients with intracranial pathology. The effect of balanced crystalloids versus saline on clinical outcomes in patients with traumatic brain injury (TBI) requires further study. We planned an a priori subgroup analysis of TBI patients enrolled in the pragmatic, cluster-randomized, multiple-crossover Isotonic Solutions and Major Adverse Renal Events Trial (SMART) (ClinicalTrials.gov: NCT02444988, NCT02547779). Primary outcome was 30-day in-hospital mortality. Secondary outcomes included hospital discharge disposition (home, facility, death). Regression models adjusted for pre-specified baseline covariates compared outcomes. TBI patients assigned to balanced crystalloids (n = 588) and saline (n = 569) had similar baseline characteristics including Injury Severity Score 19 (10); mean maximum head/neck Abbreviated Injury Score, 3.4 (1.0). Isotonic crystalloid volume administered between intensive care unit admission and first of hospital discharge or 30 days was 2037 (3470) mL and 1723 (2923) mL in the balanced crystalloids and saline groups, respectively (p = 0.18). During the study period, 94 (16%) and 82 (14%) patients (16%) died in the balanced crystalloid and saline groups, respectively (adjusted odds ratio [aOR], 1.03; 95% confidence interval [CI], 0.60 to 1.75; p = 0.913). Patients in the balanced crystalloid group were more likely to die or be discharged to another medical facility (aOR 1.38 [1.02-1.86]; p = 0.04). Overall, balanced crystalloids were associated with worse discharge disposition in critically injured patients with TBI compared with saline. The confidence intervals cannot exclude a clinically relevant increase in mortality when balanced crystalloids are used for patients with TBI.

SUBMITTER: Lombardo S

PROVIDER: S-EPMC9422787 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Balanced Crystalloid versus Saline in Adults with Traumatic Brain Injury: Secondary Analysis of a Clinical Trial.

Lombardo Sarah S Smith Michael C MC Semler Matthew W MW Wang Li L Dear Mary Lynn ML Lindsell Christopher J CJ Freundlich Robert E RE Guillamondegui Oscar D OD Self Wesley H WH Rice Todd W TW

Journal of neurotrauma 20220901 17-18

Balanced crystalloids may improve outcomes compared with saline for some critically ill adults. Lower tonicity of balanced crystalloids could worsen cerebral edema in patients with intracranial pathology. The effect of balanced crystalloids versus saline on clinical outcomes in patients with traumatic brain injury (TBI) requires further study. We planned an <i>a priori</i> subgroup analysis of TBI patients enrolled in the pragmatic, cluster-randomized, multiple-crossover Isotonic Solutions and M ...[more]

PMID: 35443809

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Project description:BACKGROUND:Comparative clinical effects of balanced crystalloids and saline are uncertain, particularly in noncritically ill patients cared for outside an intensive care unit (ICU). METHODS:We 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. RESULTS:A 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). CONCLUSIONS:Among 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 .).

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:BackgroundFluid resuscitation is a cornerstone of septic shock management in pediatric patients, with normal saline (NS) being the traditional choice. However, balanced solutions (BS) have gained attention due to their potential to mitigate acid-base and electrolyte disturbances. Despite this, the optimal choice between BS and NS for pediatric sepsis remains unclear. Therefore, we aimed to conduct a meta-analysis comparing the clinical outcomes of BS versus NS in pediatric patients with sepsis.MethodsWe systematically searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials, along with reference lists of retrieved publications, for studies comparing clinical outcomes in pediatric patients with sepsis treated with BS versus NS. Our outcomes of interest included acute kidney injury (AKI), hospital mortality, hospital length of stay, pediatric intensive care unit (PICU) length of stay, need for renal replacement therapy, hyperchloremia and mechanical ventilation. We performed statistical analysis using Review Manager Web 8.0.0 and Rstudio.ResultsWe included 12,231 patients from 8 studies, of which 4 were randomized clinical trials (RCTs). BS was used to treat septic shock in 2,460 (20.1%) patients. The mean age was 5.98 ± 3.08 years, with 43.82% female patients. Follow-up ranged from 3 to 90 days. We found no statistically significant difference between groups in AKI, hospital mortality, mechanical ventilation, need for renal replacement therapy, and PICU length of stay. Hospital length of stay in days was significantly longer with BS compared to NS (MD 3.38; 95% CI 1.13 to 5.64; p = 0.003; I² = 0%) and the occurrence of hyperchloremia was lower in the BS compared to NS (RR 0.70; 95% CI 0.59 to 0.82; p = 0.0001; I² = 0%). In a subgroup analysis of RCTs only, AKI occurrence was not significantly different between BS and NS groups (RR 0.81; 95% CI 0.48 to 1.38; p = 0.44; I² = 18%). However, the need for renal replacement therapy was significantly less frequent in patients treated with BS compared to NS (RR 0.58; 95% CI 0.39 to 0.87; p = 0.008; I² = 0%).ConclusionIn pediatric septic shock patients, treatment with balanced solutions (BS) was associated with a lower need for renal replacement therapy and a reduced occurrence of hyperchloremia. However, hospital length of stay was longer in patients treated with BS compared to those receiving normal saline (NS). These results underscore the complexity of fluid management in pediatric septic shock and emphasize the need for further research.

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Balanced Crystalloid versus Saline in Adults with Traumatic Brain Injury: Secondary Analysis of a Clinical Trial.

Publications

Balanced Crystalloid versus Saline in Adults with Traumatic Brain Injury: Secondary Analysis of a Clinical Trial.

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