plasmalyte-a and Critical-Illness

The choice of resuscitation fluid in patients with cirrhosis and sepsis-induced hypotension is unclear. 5% albumin was superior to normal saline in the FRISC study. We compared the efficacy and safety of 20% albumin, which has greater oncotic properties, to plasmalyte in reversing sepsis-induced hypotension.. Critically ill patients with cirrhosis underwent open-label randomization to receive either 20% albumin (0.5-1.0 g/kg over 3 hours; n = 50) or plasmalyte (30 ml/kg over 3 hours, n = 50). The primary endpoint of the study was the attainment of mean arterial pressure (MAP) above 65 mmHg at 3 hours.. Baseline characteristics were comparable in albumin and plasmalyte groups; arterial lactate (6.16±3.18 mmol/L vs. 6.38±4.77 mmol/L; p = 0.78), MAP (51.4±6.52 mmHg vs. 49.9±4.45 mmHg; p = 0.17) and SOFA score (10.8±2.96 vs. 11.1±4.2; p = 0.68), respectively. Most patients were alcoholics (39%) and had pneumonia (40%). In the intention-to-treat analysis, albumin was superior to plasmalyte in achieving the primary endpoint (62% vs. 22%; p <0.001). A faster decline in arterial lactate (p = 0.03), a reduced need for dialysis (48% vs. 62%; p = 0.16), and a longer time to initiation of dialysis (in hours) (68.13±47.79 vs. 99.7± 63.4; p = 0.06) were seen with albumin. However, the 28-day mortality rate was not different (58% vs. 62%, p = 0.57) and treatment had to be discontinued in 11 (22%) patients in the albumin group due to adverse effects compared to no discontinuations in the plasmalyte group.. In patients with cirrhosis and sepsis-induced hypotension, 20% albumin leads to a faster improvement in hemodynamics and lactate clearance than plasmalyte, while 28-day survival was similar. However, patients on 20% albumin need to be closely monitored as it was more often associated with pulmonary complications.. NCT02721238.. The current randomized-controlled trial performed in critically ill patients with cirrhosis and sepsis-induced hypotension highlights that 20% albumin restores arterial pressure more quickly but causes more pulmonary complications than plasmalyte. The impact on renal functions was also modest. These effects did not result in improvement in survival at 28 days. Plasmalyte is safer and well-tolerated and can be considered for volume resuscitation in patients with cirrhosis and sepsis-induced hypotension.

Topics: Albumins; Critical Illness; Electrolytes; Fluid Therapy; Humans; Hypotension, Controlled; Lactic Acid; Liver Cirrhosis; Sepsis; Shock, Septic

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.. 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.. 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).. 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 .).

Topics: Adult; Aged; Critical Illness; Cross-Over Studies; Electrolytes; Emergency Service, Hospital; Female; Fluid Therapy; Humans; Infusions, Intravenous; Intensive Care Units; Isotonic Solutions; Kidney Diseases; Male; Middle Aged; Renal Replacement Therapy; Ringer's Lactate; Sodium Chloride

Saline, 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.. The 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.. This 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.. For 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).

Topics: Acute Kidney Injury; Clinical Protocols; Critical Illness; Cross-Over Studies; Crystalloid Solutions; Electrolytes; Fluid Therapy; Hospital Mortality; Humans; Infusions, Intravenous; Intensive Care Units; Isotonic Solutions; Plasma Substitutes; Prospective Studies; Renal Replacement Therapy; Research Design; Ringer's Lactate; Risk Factors; Sodium Chloride; Tennessee; Time Factors; Treatment Outcome

Results of a study to determine potential cost benefits of substituting an alternative electrolyte solution for 0.9% sodium chloride injection for the initial fluid resuscitation of trauma patients are presented.. Using data from a randomized clinical trial that compared 24-hour fluid resuscitation outcomes in critically injured trauma patients treated with 0.9% sodium chloride injection and those who received a balanced electrolyte solution (Plasma-Lyte A, Baxter Healthcare), a cost-minimization analysis was performed at a large medical center. The outcomes evaluated included fluid and drug acquisition costs, materials and nurse labor costs, and costs associated with electrolyte replacement.. The use of Plasma-Lyte A was associated with a relatively higher fluid acquisition cost but a reduced need for magnesium replacement. During the first 24 hours of hospitalization, 4 of 24 patients (17%) treated with 0.9% sodium chloride injection and none of the patients who received the comparator product (n = 22) required supplemental magnesium. Patients treated with 0.9% sodium chloride injection received a median of 4 g of magnesium (interquartile range [IQR], 2.5-4.0 g), compared with a median of 0 g (IQR 0-2 g) in the comparator group. Taking into account the costs of consumable supplies and nursing labor, the cost-minimization analysis indicated a 24-hour cost differential of $12.35 in favor of Plasma-Lyte A.. Substitution of Plasma-Lyte A for 0.9% sodium chloride injection for fluid resuscitation during the first 24 hours after traumatic injury was associated with decreased magnesium replacement requirements and a net cost benefit to the institution.

Topics: Adult; Cost-Benefit Analysis; Critical Illness; Double-Blind Method; Electrolytes; Female; Fluid Therapy; Humans; Male; Middle Aged; Plasma Substitutes; Resuscitation; Saline Solution, Hypertonic; Wounds and Injuries; Young Adult

Normal saline has been the fluid of choice for resuscitation, rehydration and fluid replacement during plasma or red cell exchange/cytapheresis. There are increased concerns about its clinical effects and data showing it causes more haemolysis in vitro than buffered solutions such as Plasma-Lyte A.. We investigated whether normal saline or Plasma-Lyte A was associated with greater haemolysis during hours of in vitro incubation with both normal red cells and samples from patients with sickle cell anaemia.. Sickle red cells haemolysed more than normal red cells did in both crystalloid solutions. The results of 24-hour exposure to saline were particularly striking (median of 163 mg/dl (IQ range 105-247) for sickle red cells vs. 53 (48-92) for normal red cells (P < 0·0001). In patient samples containing variable quantities of haemoglobin S red cells, increased haemoglobin S was associated with increased haemolysis. This effect was greater for normal saline than Plasma-Lyte A (P = 0·12).. These in vitro models demonstrate that short-term ex vivo exposure of sickle red cells to normal saline leads to greater haemolysis than short-term exposure of normal red cells, and this effect is exacerbated by normal saline. Whether use of normal saline causes increased haemolysis in vivo is unknown. Given recent evidence that normal saline increases renal failure and mortality in critically ill patients, further studies are urgently needed.

Topics: Anemia, Sickle Cell; Anticoagulants; Blood Transfusion; Critical Illness; Electrolytes; Erythrocyte Count; Erythrocytes; Fluid Therapy; Hematologic Tests; Hemoglobin, Sickle; Hemolysis; Humans; Patient Safety; Plasma; Resuscitation; Saline Solution; Sodium Chloride

Metabolic acidosis has been implicated in the development of coagulopathy, although the specific mechanisms have not been well characterized. We sought to explore whether resuscitation of injured patients with a balanced crystalloid solution affects coagulation, as measured by endogenous thrombin potential (ETP) and thromboelastography (TEG). We performed an exploratory analysis of a subset of subjects enrolled in a randomized trial comparing the effect of resuscitation with isotonic saline versus Plasma-Lyte A (PLA) on acidosis and electrolyte abnormalities. We collected plasma at admission and 6 h later for subsequent ETP and TEG analysis and compared subjects receiving isotonic saline to those receiving PLA. Among 18 evaluated subjects, baseline characteristics, including ETP and TEG parameters, were similar between the two arms. At 6 h, subjects receiving isotonic saline were more acidemic. At 6 h, there were no differences in ETP parameters between groups; however, TEG results showed the time from initial clot formation to an amplitude of 20 mm (K) was shorter (3.8 ± 2.1 vs. 7.2 ± 2.8 s) and the rapidity of fibrin build-up and cross-linking (α angle) was significantly greater (41 ± 8 vs. 24 ± 15 deg) for the PLA group than in the isotonic saline group. Relative to PLA, isotonic saline does not alter thrombin generation, but isotonic saline and PLA may differentially impact clotting factor availability. The shorter time to reach prespecified clot amplitude and the increased rate of fibrin generation imply faster amplification of clotting factors with PLA without effect on latency time or clot strength.

Topics: Acidosis; Blood Coagulation Tests; Chlorides; Critical Illness; Crystalloid Solutions; Double-Blind Method; Electrolytes; Fluid Therapy; Hemorrhagic Disorders; Humans; Infusions, Intravenous; Isotonic Solutions; Plasma Substitutes; Randomized Controlled Trials as Topic; Resuscitation; Sample Size; Shock, Hemorrhagic; Sodium Chloride; Thrombelastography; Thrombin; Wounds and Injuries