Strict glycaemic control in patients hospitalised in a mixed medical and surgical intensive care unit: a randomised clinical trial

Introduction

Critically ill patients can develop hyperglycaemia even if they do not have diabetes. Intensive insulin therapy decreases morbidity and mortality rates in patients in a surgical intensive care unit (ICU) and decreases morbidity in patients in a medical ICU. The effect of this therapy on patients in a mixed medical/surgical ICU is unknown. Our goal was to assess whether the effect of intensive insulin therapy, compared with standard therapy, decreases morbidity and mortality in patients hospitalised in a mixed ICU.

Methods

This is a prospective, randomised, non-blinded, single-centre clinical trial in a medical/surgical ICU. Patients were randomly assigned to receive either intensive insulin therapy to maintain glucose levels between 80 and 110 mg/dl (4.4 to 6.1 mmol/l) or standard insulin therapy to maintain glucose levels between 180 and 200 mg/dl (10 and 11.1 mmol/l). The primary end point was mortality at 28 days.

Results

Over a period of 30 months, 504 patients were enrolled. The 28-day mortality rate was 32.4% (81 of 250) in the standard insulin therapy group and 36.6% (93 of 254) in the intensive insulin therapy group (Relative Risk [RR]: 1.1; 95% confidence interval [CI]: 0.85 to 1.42). The ICU mortality in the standard insulin therapy group was 31.2% (78 of 250) and 33.1% (84 of 254) in the intensive insulin therapy group (RR: 1.06; 95%CI: 0.82 to 1.36). There was no statistically significant reduction in the rate of ICU-acquired infections: 33.2% in the standard insulin therapy group compared with 27.17% in the intensive insulin therapy group (RR: 0.82; 95%CI: 0.63 to 1.07). The rate of hypoglycaemia (≤ 40 mg/dl) was 1.7% in the standard insulin therapy group and 8.5% in the intensive insulin therapy group (RR: 5.04; 95% CI: 1.20 to 21.12).

Conclusions

IIT used to maintain glucose levels within normal limits did not reduce morbidity or mortality of patients admitted to a mixed medical/surgical ICU. Furthermore, this therapy increased the risk of hypoglycaemia.

Trial Registration

clinicaltrials.gov Identifiers: 4374-04-13031; 094-2 in 000966421     

Efficacy of extended thrombo-prophylaxis in major abdominal surgery: what does the evidence show? A meta-analysis

Venous thromboembolism (VTE) is a frequent complication following major abdominal surgery. The use of low-molecular-weight heparins (LMWH) to prevent thrombotic events in these patients is a common and well documented practice. However, there is some controversy surrounding the duration of the prophylaxis, as it has been suggested that the risk persists for several weeks after surgery. The objective of this meta-analysis is to systematically review the clinical studies that compared safety and efficacy of extended use of LMWH (for three to four weeks after surgery) versus conventional in-hospital prophylaxis. An electronic data base search was performed. Only randomized, controlled studies were eligible. Data on the incidence of deep vein thrombosis (DVT), VTE and bleeding were extracted. Only three studies fulfilled the inclusion criteria. The indication for surgery was neoplastic disease in 70.6% (780/1104) of patients. The administration of extended LMWH prophylaxis significantly reduced the incidence of VTE, 5.93% (23/388) versus 13.6% (55/405), RR 0.44 (CI 95% 0.28 - 0.7); DVT 5.93% (23/388) versus 12.9% (52/402), RR 0.46 (CI 95% 0.29 - 0.74); proximal DVT 1% (4/388) versus 4.72% (19/402), RR 0.24 (CI 95% 0.09 - 0.67). We found no significant difference in major or minor bleeding between the two groups: 3.85% (21/545) in the extended thrombo-prophylaxis (ETP) group versus 3.48% (19/559) in the conventional prophylaxis group; RR 1.12 (CI 95% 0.61 - 2.06). There was no heterogeneity between the studies. We conclude that ETP with LMWH should be considered as a safe and useful strategy to prevent VTE in high-risk major abdominal surgery.     

Prior antiplatelet use and infarct volume in ischemic stroke

BACKGROUND: Conflicting data exist on the role of antiplatelet agents in reducing incident ischemic stroke magnitude, but most prior studies used clinically-assessed neurologic deficit as the index of stroke extent rather than more precise volumetric measurements of infarct size. We assessed the relation of premorbid antiplatelet use to initial diffusion-weighted MRI (DWI) lesion volumes among acute ischemic stroke patients. METHODS: Consecutive patients presenting within 24 h of ischemic stroke over an 18-month period were studied. DWI lesions were outlined using a semi-automated threshold technique. Subjects were categorized into two groups: antiplatelet (AP) or no antithrombotic (NA). The relationship between prestroke antithrombotic status and DWI infarct volumes was examined using multivariate quantile regression. RESULTS: One hundred sixty-six individuals met study criteria: 75 AP and 91 NA patients. Median DWI volume was lower in the AP group than in the NA group (1.5 cc vs. 5.4 cc, p=0.031). A multivariable model (adjusting for age, history of transient ischemic attack, admission temperature, admission blood pressure, admission serum glucose, stroke onset to imaging interval, stroke mechanism, premorbid statin and antihypertensive use) demonstrated smaller infarcts in the AP vs. NA group (adjusted volume difference: -1.3 cc, 95% CI=-0.09, -2.5, p=0.037). Prior statin use, no history of TIA, large vessel atherosclerosis and microvascular ischemic disease stroke mechanism were also independently associated with reduced infarct volume. CONCLUSIONS: Prior antiplatelet treatment is independently associated with reduced cerebral infarct volume among acute ischemic stroke patients. Premorbid statin use, TIA history and stroke mechanism also predict infarct volume in ischemic stroke.     

Laparoscopic leak-free technique for the treatment of choledochal cysts

OBJECTIVE: The aim of this report was to present our experience with a modified surgical technique designed for the treatment of choledochal cysts (CC) in children. MATERIALS AND METHODS: Between June 2004 and February 2005, we operated on 6 patients with a diagnosis of type I CC by means of a "leak-free" technique that consists of a transient complete sealing of the hepatic duct for the duration of the dissection, and a single- or double laparoscopic running suture to build the end-to-side hepatico-jejuno anastomosis. There were 4 females and 2 males, whose age ranged between 45 days and 7 years (median, 45 months). All cases were performed with three trocars plus the scope, and two or three percutaneous stay-stitches to retract the liver. The end-to-side hepatico-jejuno anastomoses were done with 5.0 or 6.0 PDS. We left no drains. RESULTS: The mean operative time was 335 minutes, and mean postoperative time to oral feeding was 44 hours. The mean hospital stay was 6 days (range, 5-10). No postoperative biliary leak was observed. A cosmetic result was excellent in all patients. In the follow-up (mean, 12 months), all patients were asymptomatic, had no intrahepatic biliary tree dilation, and had normal liver function tests. CONCLUSIONS: Based on the results of our series, we think that the laparoscopic approach is suitable for these patients, but some surgical details should be followed to lower the complication rate. First, a temporary closure of the hepatic duct to prevent bile spillage during the dissection is important for keeping the area clean and thus reducing the operative time. Second, the use of a running suture for the hepatico-jejunostomy, even though it may be technically challenging, should always be attempted to avoid postoperative bile leaks in these high-flow anastomoses.     

Laparoscopic resection of an extra-adrenal pheochromocytoma

Extra-adrenal pheochromocytomas are of rare occurrence. Since first reported laparoscopic adrenalectomy has become the gold standard in the treatment of adrenal tumors, the feasibility of laparoscopic adrenalectomy in the setting of pheochromocytoma has also been established given a careful preoperative planning. Literature on the laparoscopic treatment of extra-adrenal pheochromocytomas is lacking. We report a hypertensive 54-year-old male patient (body mass index, 26.2) with elevated urinary catecholamines and a 6-cm solid mass under the right renal hilum diagnosed after a magnetic resonance. The patient underwent complete transperitoneal laparoscopic excision of the tumor. Recovery was uneventful and final histopathologic examination showed an extra-adrenal pheochromocytoma. We believe that transperitoneal laparoscopic excision of extra-adrenal pheochromocytoma is a feasible and reproducible technique that allows for complete removal of tumoral tissue with low morbidity, shorter hospital stay, and minimal convalescence.     

Laparoscopic pericardio-peritoneal window: an alternative approach in the treatment of recurrent pericardial effusion, in-hospital evolution and survival

BACKGROUND: Although cardiac tamponade due to pericardial effusion is not frequently seen it may, in many cases require surgical drainage. The aim of this study is to show our experience with a laparoscopic approach to perform the pericardio-peritoneal window in the management of recurrent pericardial effusion. METHODS: We included 16 patients with recurrent pericardial effusion and echocardiographic global tamponade. A pneumoperitoneum was made and 3 trocars were placed; an avascular area of the diaphragm was chosen and a pericardial window was made (4 cm diameter). RESULTS: Pericardial-peritoneal window was carried out successfully (mean operative time 40 min). All patients presented relief of symptoms. The mean follow-up was 729 days. No patient experienced recurrence on repeated ecocardiographic examinations. There were no fatal events related to the procedure. CONCLUSIONS: Laparoscopic pericardial window is a simple, safe, and effective alternative for the treatment of recurrent pericardial effusion with global cardiac tamponade.     

High expression of lymphocyte-associated genes in node-negative HER2+ breast cancers correlates with lower recurrence rates

Gene expression analysis has identified biologically relevant subclasses of breast cancer. However, most classification schemes do not robustly cluster all HER2+ breast cancers, in part due to limitations and bias of clustering techniques used. In this article, we propose an alternative approach that first separates the HER2+ tumors using a gene amplification signal for Her2/neu amplicon genes and then applies consensus ensemble clustering separately to the HER2+ and HER2- clusters to look for further substructure. We applied this procedure to a microarray data set of 286 early-stage breast cancers treated only with surgery and radiation and identified two basal and four luminal subtypes in the HER2- tumors, as well as two novel and robust HER2+ subtypes. HER2+ subtypes had median distant metastasis-free survival of 99 months [95% confidence interval (95% CI), 83-118 months] and 33 months (95% CI, 11-54 months), respectively, and recurrence rates of 11% and 58%, respectively. The low recurrence subtype had a strong relative overexpression of lymphocyte-associated genes and was also associated with a prominent lymphocytic infiltration on histologic analysis. These data suggest that early-stage HER2+ cancers associated with lymphocytic infiltration are a biologically distinct subtype with an improved natural history.