Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: a randomized controlled trial
BACKGROUND : Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Several methods to prevent post-ESD bleeding (PEB) have been introduced; however, they have not been widely used because of technical difficulties. We aimed to investigate whether polysaccharide hemostatic powder (PHP), which is very easy to apply, can prevent early post-ESD bleeding, especially in patients with a high risk of post-ESD bleeding. METHODS : This was a prospective, multicenter, randomized, open-label, controlled trial. Patients with a high risk for post-ESD bleeding were enrolled. Patients with gastric neoplasms in whom the resected specimen size was expected to be > 40 mm and those who were regularly taking antithrombotic agents were defined as high risk patients. Patients were randomly assigned to the PHP or control groups. RESULTS Between May 2017 and September 2018, 143 patients were enrolled (PHP group, 73; control group, 70). The total post-ESD bleeding rate was 6.3 % (PHP group, 5.5 % vs. control group, 7.1 %; P = 0.74). There was no bleeding within 7 days after ESD in the PHP group. Continued antithrombotic use was an independent risk factor for post-ESD bleeding. In subgroup analysis excluding the patients who continued to take antithrombotic agents (n = 129) during ESD, the rate of post-ESD bleeding tended to be lower in the PHP group than in the control group (0 % vs. 6.3 %; P = 0.06). CONCLUSION : PHP did not demonstrate a significant effect on the prevention of post-ESD bleeding in this study. Further larger scale, randomized controlled trials are needed to confirm this.
Changes in plasma volume before and after major abdominal surgery following stroke volume variation-guided fluid therapy: a randomized controlled trial
Minerva anestesiologica. 2019
BACKGROUND The aim of intraoperative fluid therapy is to avoid both hypovolemia and hypervolemia; however, the patient's exact volume status is difficult to determine during surgery. Fluid optimization guided by stroke volume variation (SVV) has been widely used in patients undergoing major open abdominal surgery. The aim of this study was to evaluate the changes in plasma volume before and after surgery following SVV-guided fluid therapy. METHODS Patients were randomly allocated into one of two groups according to the SVV criteria for fluid administration during surgery. In the fixed SVV fluid strategy group, fluid was administered to maintain the SVV below 13%. In the individual SVV group, individual SVV values of each patient were maintained until the end of surgery. Plasma volume, body weight, and extracellular water (ECW) were measured before and after surgery. Plasma volume was estimated using the indocyanine green dilution technique. RESULTS A total of 118 patients were included. Median (25-75%) plasma volumes in the preoperative and postoperative period were 2.46 (2.20-2.88) L and 2.69 (2.33-3.12) L for the fixed SVV group (n=57, P=0.133), respectively, and 2.56 (2.23-2.90) L and 2.89 (2.48-3.19) L for the individual SVV group (n=61, P<0.001), respectively. CONCLUSIONS Fluid administration during surgery to maintain SVV below 13% was effective for maintaining the preoperative plasma volume until the end of surgery in patients undergoing major open stomach or colorectal surgery. This result supports the validity of SVV-guided fluid therapy, which maintains the SVV value below 13%, in terms of maintaining patient volume status.
Liberal versus restrictive transfusion strategy in critically ill oncologic patients: the Transfusion Requirements in Critically Ill Oncologic Patients randomized controlled trial
Critical Care Medicine. 2017;45((5):):766-773
OBJECTIVE To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. DESIGN Single center, randomized, double-blind controlled trial. SETTING Teaching hospital. PATIENTS Adult cancer patients with septic shock in the first 6 hours of ICU admission. INTERVENTIONS Patients were randomized to the liberal (hemoglobin threshold, < 9g/dL) or to the restrictive strategy (hemoglobin threshold, < 7g/dL) of RBC transfusion during ICU stay. MEASUREMENTS AND MAIN RESULTS Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p < 0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53-0.97; p = 0.03). CONCLUSIONS We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed.
Effect of perioperative goal-directed hemodynamic resuscitation therapy on outcomes following cardiac surgery: a randomized clinical trial and systematic review
Critical Care Medicine. 2016;44((4)):724-33.
OBJECTIVES To evaluate the effects of goal-directed therapy on outcomes in high-risk patients undergoing cardiac surgery. DESIGN A prospective randomized controlled trial and an updated metaanalysis of randomized trials published from inception up to May 1, 2015. SETTING Surgical ICU within a tertiary referral university-affiliated teaching hospital. PATIENTS One hundred twenty-six high-risk patients undergoing coronary artery bypass surgery or valve repair. INTERVENTIONS Patients were randomized to a cardiac output-guided hemodynamic therapy algorithm (goal-directed therapy group, n = 62) or to usual care (n = 64). In the goal-directed therapy arm, a cardiac index of greater than 3 L/min/m was targeted with IV fluids, inotropes, and RBC transfusion starting from cardiopulmonary bypass and ending 8 hours after arrival to the ICU. MEASUREMENTS AND MAIN RESULTS The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications. Patients from the goal-directed therapy group received a greater median (interquartile range) volume of IV fluids than the usual care group (1,000 [625-1,500] vs 500 [500-1,000] mL; p < 0.001], with no differences in the administration of either inotropes or RBC transfusions. The primary outcome was reduced in the goal-directed therapy group (27.4% vs 45.3%; p = 0.037). The goal-directed therapy group had a lower occurrence rate of infection (12.9% vs 29.7%; p = 0.002) and low cardiac output syndrome (6.5% vs 26.6%; p = 0.002). We also observed lower ICU cumulative dosage of dobutamine (12 vs 19 mg/kg; p = 0.003) and a shorter ICU (3 [3-4] vs 5 [4-7] d; p < 0.001) and hospital length of stay (9 [8-16] vs 12 [9-22] d; p = 0.049) in the goal-directed therapy compared with the usual care group. There were no differences in 30-day mortality rates (4.8% vs 9.4%, respectively; p = 0.492). The metaanalysis identified six trials and showed that, when compared with standard treatment, goal-directed therapy reduced the overall rate of complications (goal-directed therapy, 47/410 [11%] vs usual care, 92/415 [22%]; odds ratio, 0.40 [95% CI, 0.26-0.63]; p < 0.0001) and decreased the hospital length of stay (mean difference, -5.44 d; 95% CI, -9.28 to -1.60; p = 0.006) with no difference in postoperative mortality: 9 of 410 (2.2%) versus 15 of 415 (3.6%), odds ratio, 0.61 (95% CI, 0.26-1.47), and p = 0.27. CONCLUSIONS Goal-directed therapy using fluids, inotropes, and blood transfusion reduced 30-day major complications in high-risk patients undergoing cardiac surgery.
The role of second-look endoscopy and prophylactic hemostasis after gastric endoscopic submucosal dissection: a systematic review and meta-analysis
Journal of Gastroenterology and Hepatology. 2016;32((4):):756-768
BACKGROUND Although several studies have shown that second-look endoscopy does not affect the incidence of bleeding after gastric endoscopic submucosal dissection (ESD), the potential roles of second-look endoscopy have not been fully evaluated. We aimed to determine the role of second-look endoscopy after ESD through a systematic review and meta-analysis. METHODS We conducted a systematic literature search of MEDLINE, EMBASE, and the Cochrane Library through March 2016 using the keywords "second-look," "prophylactic hemostasis," "prophylactic haemostasis," "prevention," "prophylaxis," and "endoscopic submucosal dissection." Studies were included if they evaluated the incidence of post-ESD bleeding according to second-look endoscopy or prophylactic hemostasis during second-look endoscopy. RESULTS Four randomized controlled trials on post-ESD bleeding between second-look endoscopy and no second-look endoscopy and 12 non-randomized studies with a cohort design on post-ESD bleeding were included. On meta-analysis, second-look endoscopy did not affect delayed post-ESD bleeding (odds ratio [95% confidence interval] = 1.27 [0.80-2.00], I2 = 0%). During second-look endoscopy, patients who were considered as high-risk for post-ESD bleeding underwent prophylactic hemostasis. Delayed post-ESD bleeding was more common in patients who were treated with hemostasis during second-look endoscopy compared to those who were not (odds ratio [95% confidence interval] = 3.40 [1.87-6.18], I2 = 62%). In patients who underwent prophylactic hemostasis, number needed to prolong a hospitalization period to avoid one additional post-ESD bleeding after discharge was 25. CONCLUSION Second-look endoscopy after ESD could not reduce the risk of delayed post-ESD bleeding. Delayed post-ESD bleeding was more common in patients who underwent prophylactic hemostasis than in those who did not.
A prospective, randomized trial comparing mechanical methods of hemostasis plus epinephrine injection to epinephrine injection alone for bleeding peptic ulcer
Gastrointestinal Endoscopy. 2004;60((2)):173-9.
BACKGROUND The hemostatic efficacy of mechanical methods of hemostasis, together with epinephrine injection, was compared with that of epinephrine injection alone in bleeding peptic ulcer. METHODS Ninety patients with a peptic ulcer with active bleeding or a non-bleeding visible vessel were randomly assigned to undergo a mechanical method of hemostasis (23 hemoclip application, 22 band ligation) plus epinephrine injection, or epinephrine injection alone. RESULTS The two groups were similar with respect to all background variables. Initial hemostasis was achieved in 44/45 (97.8%) patients in both groups. The mean number of hemoclips and elastic bands applied were 2.8: 95% CI[2.5, 3.1] and 1.1: 95% CI[1.0, 1.2], respectively, and the mean volume of epinephrine injected was 19.9 mL: 95% CI[19.3 mL, 20.5 mL]. The rate of recurrent bleeding in the combination group (2/44, 4.5%) was significantly lower in comparison with the injection group (9/44, 20.5%, p < 0.05). The mean number of therapeutic endoscopic sessions needed to achieve permanent hemostasis in the combination group (1.04: 95% CI[1.01, 1.07]) was significantly lower vs. the injection group (1.22: 95% CI[1.15, 1.30]). CONCLUSIONS The combination of an endoscopic mechanical method of hemostasis plus epinephrine injection is more effective than epinephrine injection alone for the treatment of bleeding peptic ulcer. RN YKH834O4BH (Epinephrine).