Efficacy and Safety of Fibrinogen Concentrate in Surgical Patients: A Meta-Analysis of Randomized Controlled Trials.

OBJECTIVES: To investigate the efficacy and safety of fibrinogen concentrate (FC) in surgical patients. DESIGN: Meta-analysis of randomized controlled studies (RCTs). SETTING: Perioperative. PARTICIPANTS: Adult and pediatric surgical patients. INTERVENTIONS: A search of PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, Transfusion Evidence Library, Google Scholar, and the proceedings from major international anesthesiology meetings up to February 1, 2016 for RCTs that compared FC with placebo or other comparators. MEASUREMENTS AND MAIN RESULTS: The primary outcome was all-cause mortality. Pooled risk ratios and mean differences (MDs) were computed with either fixed-effects or random-effects models. The study included 14 RCTs comprising 1,035 patients; the majority of patients underwent cardiac surgery. All-cause mortality was lower in the fibrinogen group (4/432 [0.9%] v 15/430 [3.5%]; risk ratio 0.26; 95% confidence interval [CI] 0.09-0.78; p = 0.02; heterogeneity statistic (l2) = 0%). The use of FC was associated with reduced bleeding (MD -127 mL; 95% CI -207 to -47; p = 0.002; I2= 54%) and a lower number of red blood cells units transfused versus comparator (MD -0.9; 95% CI -1.3 to -0.5; p<0.001; I2 = 42%). There were no differences in the rates of thrombotic events and myocardial infarction. CONCLUSIONS: In surgical patients, FC was associated with reduced bleeding and a lower number of red blood cell units transfused, and it also might reduce mortality. However, none of the analyzed trials was powered for estimation of survival and adverse events with FC use. Half of the included studies were of high or moderate risk of bias. The evidence primarily came from cardiac surgery settings.

Infusion of 7.2% NaCl/6% hydroxyethyl starch 200/0.5 in on-pump coronary artery bypass surgery patients: a randomized, single-blind pilot study.

BACKGROUND: NaCl 7.2%/6% hydroxyethyl starch (HES) 200/0.5 (HSH) has shown its beneficial effects in cardiac surgery and immunomodulatory values in experiment and human studies. However, there is concern regarding detrimental renal effects of chloride and HES in the intensive care setting. OBJECTIVES: The objective of this study was to evaluate the influence of HSH on kidney integrity and the level of inflammatory mediators in on-pump coronary artery bypass surgery patients. DESIGN: This was a single-center, prospective, randomized, single-blind pilot study. SETTING: This work was performed at a tertiary cardiothoracic referral center during the period from February to August 2012. PATIENTS: Forty patients scheduled for on-pump coronary artery bypass surgery were included. INTERVENTIONS: PATIENTS were randomized to receive once either 7.2% NaCl/6% HES 200/0.5 (HSH group, n = 20) or placebo (0.9% NaCl; control group, n = 20) at a dose of 4 mL·kg for 30 min after anesthesia induction. MAIN OUTCOME MEASURES: The primary end point was the incidence of acute kidney injury (AKI) defined according to the Kidney Disease: Improving Global Outcomes. Secondary end points were peak serum cystatin C, peak urine neutrophil gelatinase-associated lipocalin, plasma levels of interleukin 6 (IL-6), IL-10, intercellular adhesion molecule 1, and endothelial-leukocyte adhesion molecule (E-selectin). RESULTS: The incidence of AKI within 48 h was similar between the groups (HSH: four patients [20%]; control: six patients [30%]). There was a significantly lower peak value for serum cystatin C in the HSH group (0.83 [0.73-0.89] mg·L) compared with the control group (1.02 [0.88-1.15] mg·L; P = 0.001). PATIENTS in both groups had similar peak postoperative urine neutrophil gelatinase-associated lipocalin concentrations. NaCl 7.2%/6% hydroxyethyl starch 200/0.5 significantly reduces levels of IL-6 and IL-10 at 4 h after cardiopulmonary bypass and intercellular adhesion molecule 1 and E-selectin at 4 h after cardiopulmonary bypass and on postoperative day 1 (P < 0.05 for all). CONCLUSIONS: NaCl 7.2%/6% hydroxyethyl starch 200/0.5 does not lead to the increase in AKI incidence when used for the volume therapy in on-pump coronary artery bypass surgery patients. NaCl 7.2%/6% hydroxyethyl starch 200/0.5 usage enhanced neither tubular injury nor alteration of glomerular filtration. In addition, HSH can reduce the level of the inflammatory mediators after surgery.

Hypertonic solution decreases extravascular lung water in cardiac patients undergoing cardiopulmonary bypass surgery.

OBJECTIVE: To test the hypothesis that the infusion of hypertonic solution would decrease extravascular lung water postoperatively and thus improve pulmonary function. DESIGN: Prospective, randomized, blinded trial. SETTING: Tertiary cardiothoracic referral center. PARTICIPANTS: Twenty-six patients with coronary artery disease who underwent surgery with cardiopulmonary bypass (CPB). INTERVENTIONS: Patients were allocated randomly to receive 4 mL/kg of 7.2% NaCl/hydroxyethyl starch, 200/0.5 (HSH group) or an equal volume of 0.9% NaCl (control group) for 30 minutes starting after anesthesia induction. The extravascular lung water index, hemodynamic and biochemical data, and the rate of complications were analyzed. MEASUREMENTS AND MAIN RESULTS: The extravascular lung water index was significantly lower (7 v 9.5 mL/kg) in the HSH group at the first postoperative day (p < 0.01). The index of arterial oxygenation efficiency was significantly higher at 5 minutes and 2 and 4 hours after cardiopulmonary bypass (CPB) in the HSH group (p < 0.05). The alveolar-arterial oxygen tension difference was significantly lower at 5 minutes and 2 and 4 hours after CPB in the HSH group (p < 0.01). The cardiac index was significantly higher at 5 minutes after infusion in the HSH group (p < 0.05). CONCLUSIONS: The infusion of HSH leads to significant decreases in the extravascular lung water index during and after cardiac surgery and is associated with better preservation of pulmonary function and transient increases in the cardiac index. Further trials are needed to clarify the clinical advantages of hypertonic solution administration in patients undergoing surgery with CPB.