Reply to Swenson: Balanced Crystalloid versus Saline Solution in Critically Ill Patients: Is Chloride the Villain?
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SUBMITTER: Semler MW
PROVIDER: S-EPMC6680297 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC6680295 | biostudies-literature
Project description:BACKGROUND:Both balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults, but it is not known which results in better clinical outcomes. METHODS:In a pragmatic, cluster-randomized, multiple-crossover trial conducted in five intensive care units at an academic center, we assigned 15,802 adults to receive saline (0.9% sodium chloride) or balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A) according to the randomization of the unit to which they were admitted. The primary outcome was a major adverse kidney event 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:Among the 7942 patients in the balanced-crystalloids group, 1139 (14.3%) had a major adverse kidney event, as compared with 1211 of 7860 patients (15.4%) in the saline group (marginal odds ratio, 0.91; 95% confidence interval [CI], 0.84 to 0.99; conditional odds ratio, 0.90; 95% CI, 0.82 to 0.99; P=0.04). In-hospital mortality at 30 days was 10.3% in the balanced-crystalloids group and 11.1% in the saline group (P=0.06). The incidence of new renal-replacement therapy was 2.5% and 2.9%, respectively (P=0.08), and the incidence of persistent renal dysfunction was 6.4% and 6.6%, respectively (P=0.60). CONCLUSIONS:Among critically ill adults, the use of balanced crystalloids for intravenous fluid administration resulted in a lower rate of the composite outcome of death from any cause, new renal-replacement therapy, or persistent renal dysfunction than the use of saline. (Funded by the Vanderbilt Institute for Clinical and Translational Research and others; SMART-MED and SMART-SURG ClinicalTrials.gov numbers, NCT02444988 and NCT02547779 .).
| S-EPMC5846085 | biostudies-literature
Project description:Objectives:Intravenous fluids are one of the most used medical therapy for patients, especially critically ill patients. We conducted a meta-analysis comparing between balanced crystalloids and normal saline in critically ill patients and its effect on various clinical outcomes. Design:Meta-analysis and systematic review of randomized clinical trials (RCTs). Methods and data source:Electronic search was performed using PubMed, Cochrane library, and clinical trials.gov from inception through March 1, 2018, with inclusion of prospective studies that investigated one of the primary outcomes which were acute kidney injury (AKI) and in-hospital mortality while secondary outcomes were intensive care unit (ICU) mortality and new renal replacement therapy (RRT). Results:Six RCTs were included. Total of 19,332 patients were included in the final analysis. There was no significant difference in in-hospital mortality (11.5% vs 12.2%; OR 0.92; 95% CI 0.85-1.01; P?=?0.09; I2 =?0%), incidence of AKI (12% vs 12.7%, OR 0.92; 95% CI 0.84-1.01; P?=?0.1; I2 =?0), overall ICU mortality (OR 0.9, 95% CI 0.81-1.01, P?=?0.08, I2 =?0%), or need for new RRT (OR 0.92, 95% CI 0.67-1.28, P?=?0.65, I2 =?38%) between balanced crystalloids and isotonic saline in critically ill patients. Conclusion:Balanced crystalloids and isotonic saline have no difference on various clinical outcomes including in-hospital mortality, AKI, overall ICU mortality, and new RRT. Further powerful clinical trials are required to determine the relationship between crystalloid fluid type and clinical outcomes.
| S-EPMC6098635 | biostudies-literature
Project description:ObjectiveTo compare the safety of balanced crystalloids and saline among critically ill patients in intensive care unit (ICU).MethodsThe Medline, EMBASE, Web of Science, Cochrane Library databases were systematically searched from the inception dates to May 17, 2020 in order to identify randomized controlled trials which evaluated the safety of balanced crystalloids and saline in critically ill patients. The primary outcome was major adverse kidney events within 30 days (MAKE30). The second outcomes included 30-day mortality, ICU mortality, In-hospital mortality, ICU length of stay, hospital length of stay, creatinine highest before discharge (mg/dl) and needs for renal replacement therapy (RRT).ResultsA total of nine randomized controlled trials involving 19,578 critical ill patients fulfilled the inclusion criteria. The outcomes of this meta-analysis showed that balanced crystalloids treatment shared the same risk of MAKE30 with saline treatment among critical ill patients [RR = 0.95; 95%CI, 0.88 to 1.01; Z = 1.64 (P = .102)]. The clinical mortality which included 30-day mortality [RR = 0.92; 95%CI, 0.85 to 1.01; Z = 1.78 (P = .075)], ICU mortality [RR = 0.92; 95%CI, 0.83 to 1.02; Z = 1.67 (P = .094)] and In-hospital mortality [RR = 0.93; 95%CI, 0.71 to 1.21; Z = 0.55 (P = .585)] were similar between balanced crystalloids treatment and saline treatment among critical ill patients. Patients who received balanced crystalloids treatment or saline treatment needed the same length of ICU stay [WMD = 0.00; 95%CI, -0.09 to 0.10; Z = 0.09 (P = .932)] and hospital stay [WMD = 0.59; 95%CI, -0.33 to 1.51; Z = 1.26 (P = .209)]. Critical ill patients who received balanced crystalloids treatment or saline treatment had the same level of creatinine highest before discharge [WMD = 0.01; 95%CI, -0.02 to 0.04; Z = 0.76 (P = .446)] and needs for RRT [RR = 1.04; 95%CI, 0.75 to 1.43; Z = 0.21 (P = .830)]. Similar results were obtained in subgroups of trials stratified according to the age of patients (children or adults).ConclusionsWhen compared with saline, balanced crystalloids could not reduce the risk of MAKE30, 30-day mortality, ICU mortality and in-hospital mortality, could not reduce the length of ICU stay, length of hospital stay, the level of creatinine highest before discharge and the needs for RRT among critical ill children and adults. Therefore, it was still too early for balanced crystalloids to replace normal saline among critical ill patients.
| S-EPMC8462635 | biostudies-literature
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 .).
| S-EPMC5846618 | biostudies-literature
Project description:BackgroundRecent trials have suggested use of balanced crystalloids may decrease the incidence of major adverse kidney events compared to saline in critically ill adults. The effect of crystalloid composition on biomarkers of early acute kidney injury remains unknown.MethodsFrom February 15 to July 15, 2016, we conducted an ancillary study to the Isotonic Solutions and Major Adverse Renal Events Trial (SMART) comparing the effect of balanced crystalloids versus saline on urinary levels of neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) among 261 consecutively-enrolled critically ill adults admitted from the emergency department to the medical ICU. After informed consent, we collected urine 36 ± 12 h after hospital admission and measured NGAL and KIM-1 levels using commercially available ELISAs. Levels of NGAL and KIM-1 at 36 ± 12 h were compared between patients assigned to balanced crystalloids versus saline using a Mann-Whitney U test.ResultsThe 131 patients (50.2%) assigned to the balanced crystalloid group and the 130 patients (49.8%) assigned to the saline group were similar at baseline. Urinary NGAL levels were significantly lower in the balanced crystalloid group (median, 39.4 ng/mg [IQR 9.9 to 133.2]) compared with the saline group (median, 64.4 ng/mg [IQR 27.6 to 339.9]) (P < 0.001). Urinary KIM-1 levels did not significantly differ between the balanced crystalloid group (median, 2.7 ng/mg [IQR 1.5 to 4.9]) and the saline group (median, 2.4 ng/mg [IQR 1.3 to 5.0]) (P = 0.36).ConclusionsIn this ancillary analysis of a clinical trial comparing balanced crystalloids to saline among critically ill adults, balanced crystalloids were associated with lower urinary concentrations of NGAL and similar urinary concentrations of KIM-1, compared with saline. These results suggest only a modest reduction in early biomarkers of acute kidney injury with use of balanced crystalloids compared with saline.Trial registrationClinicalTrials.gov number: NCT02444988 . Date registered: May 15, 2015.
| S-EPMC7863046 | biostudies-literature
Project description:Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To determine the effects of balanced crystalloid solutions in comparison to 0.9% saline to rehydrate children with severe dehydration due to acute diarrhoea.
| S-EPMC7266490 | biostudies-literature
Project description:ObjectiveTo report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS).MethodsBaSICS 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.ResultsBaSICS 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.ConclusionThis 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.
| S-EPMC7853670 | biostudies-literature
Project description:Intravenous fluid therapy is the most common intervention received by acutely ill patients. Historically, saline (0.9% sodium chloride) has been the most frequently administered intravenous fluid, especially in North America. Balanced crystalloid solutions (e.g., lactated Ringer's, Plasma-Lyte) are an increasingly used alternative to saline. Balanced crystalloids have a sodium, potassium, and chloride content closer to that of extracellular fluid and, when given intravenously, have fewer adverse effects on acid-base balance. Preclinical research has demonstrated that saline may cause hyperchloremic metabolic acidosis, inflammation, hypotension, acute kidney injury, and death. Studies of patients and healthy human volunteers suggest that even relatively small volumes of saline may exert physiological effects. Randomized trials in the operating room have demonstrated that using balanced crystalloids rather than saline prevents the development of hyperchloremic metabolic acidosis and may reduce the need for vasopressors. Observational studies among critically ill adults have associated receipt of balanced crystalloids with lower rates of complications, including acute kidney injury and death. Most recently, large randomized trials among critically ill adults have examined whether balanced crystalloids result in less death or severe renal dysfunction than saline. Although some of these trials are still ongoing, a growing body of evidence raises fundamental concerns regarding saline as the primary intravenous crystalloid for critically ill adults and highlights fundamental unanswered questions for future research about fluid therapy in critical illness.
| S-EPMC6467313 | biostudies-literature
Project description:ObjectivesTo compare 5% albumin with 0.9% saline for large-volume resuscitation (> 60 mL/Kg within 24 hr), on mortality and development of acute kidney injury.DesignRetrospective cohort study.SettingPatients admitted to ICUs in 13 hospitals across Western Pennsylvania. We analyzed two independent cohorts, the High-Density Intensive Care databases: High-Density Intensive Care-08 (July 2000 to October 2008, H08) and High-Density Intensive Care-15 (October 2008 to December 2014, H15).PatientsTotal of 18,629 critically ill patients requiring large-volume resuscitation.InterventionsFive percent of albumin in addition to saline versus 0.9% saline.Measurements and main resultsAfter excluding patients with acute kidney injury prior to large-volume resuscitation, 673 of 2,428 patients (27.7%) and 1,814 of 16,201 patients (11.2%) received 5% albumin in H08 and H15, respectively. Use of 5% albumin was associated with decreased 30-day mortality by multivariate regression in H08 (odds ratio 0.65; 95% CI 0.49-0.85; p = 0.002) and in H15 (0.52; 95% CI 0.44-0.62; p < 0.0001) but was associated with increased acute kidney injury in H08 (odds ratio 1.98; 95% CI 1.56-2.51; p < 0.001) and in H15 (odds ratio 1.75; 95% CI 1.58-1.95; p < 0.001). However, 5% albumin was not associated with persistent acute kidney injury and resulted in decreased major adverse kidney event at 30, 90, and 365 days. Propensity matched analysis confirmed similar associations with mortality and acute kidney injury.ConclusionsDuring large-volume resuscitation, 5% albumin was associated with reduced mortality and major adverse kidney event at 30, 90, and 365 days. However, a higher rate of acute kidney injury of any stage was observed that did not translate into persistent renal dysfunction.
| S-EPMC7746571 | biostudies-literature