Prevention of colonization and infection in critically ill patients: a prospective randomized study

In a prospective randomized study to determine whether prevention of colonization of Gram-negative bacteria results in prevention of Gram-negative bacterial infections, 96 intensive care patients were randomly allocated into a control group and a study group. The study group received oral nonabsorbable antimicrobial agents (i.e., tobramycin, amphotericin B, and polymyxin E) in addition to parenteral antibiotics. Colonization with Gram-negative microorganisms in the oropharynx, and respiratory and digestive tracts increased in the control group during their stay, while the study group did not tend to colonize with Gram-negative bacteria. In the control group, 107 nosocomial infections were diagnosed, vs. 42 nosocomial infections in the study group. Nosocomial infections caused by Gram-negative bacteria were significantly less frequent in the study group. Mortality due to an acquired infection was significantly less frequent in the study group. We conclude that colonization, infection, and subsequent mortality by nosocomial Gram-negative bacteria can be prevented by a regime of topically applied nonabsorbable antibiotics.     

The role of tilt training in preventing recurrent syncope in patients with vasovagal syncope: a prospective and randomized study

Background: Recurrent vasovagal syncope (VVS) can be a severely disabling disorder that may lead to an important deterioration of quality of life because of the severity and recurrence of episodes. This study sought to investigate the effectiveness of repeated orthostatic self-training in preventing syncope in patients with recurrent VVS.
Methods: Eighty-two consecutive patients (mean age 41 ± 4 years, 37 males) with recurrent VVS episodes and positive head-up tilt testing (HUT) were enrolled in this study. The patients were then randomized (1:1) to conventional therapy or conventional therapy plus additional tilt training sessions. The patients were followed for spontaneous syncope for one year. Primary end-points were the recurrence of syncope, the number of episodes, and the interval of time to the first recurrence.
Results: There were no significant differences of baseline clinical characteristics and parameters of HUT between the tilt training and control groups. The patients had 4 ± 2/year syncopal episodes prior to the HUT. The mean follow-up after randomization was 12 ± 2 months. Spontaneous syncope recurrence during follow-up was 56% (23 patients) versus 37% (15 patients) in the control and tilt training groups, respectively (P = 0.1). Time to first recurrence was also similar in both groups (70 ± 20 days vs 50 ± 15 days, P = 0.09). The frequency of recurrent syncopes was similar in all types of VVSs while the rate of episodes was significantly higher in control group in patients with vasodepressor type during follow-up period (32% vs 10%, P = 0.04). The mean number of recurrent syncope episodes was also similar in both groups (3 ± 1 vs 2 ± 1, P = 0.4).
Conclusions: Tilt training was unable to influence the spontaneous syncope recurrence for recurrent VVS except for vasodepressor type.     

Early refeeding after endoscopic biliary or pancreatic sphincterotomy: a randomized prospective study

BACKGROUND AND STUDY AIMS: Patients who have undergone endoscopic sphincterotomy (ES) are usually left to fast for arbitrary reasons until they are examined on the following day. The aim of this study was to check whether this systematic fasting after ES is actually justified. PATIENTS AND METHODS: A blinded randomized prospective study, involving 146 patients, was carried out from January 1999 to September 2001. All patients undergoing biliary and/or pancreatic endoscopic sphincterotomy during this period were randomly allocated to one of two groups: group 1 patients were re-fed 4 hours after ES, and the group 2 patients were only re-fed 24 hours after the procedure. These two groups were comparable for clinical and procedural data except for stenting. RESULTS: Eight patients in group 1 (11 %) and 26 patients in group 2 (37 %) suffered from abdominal pain which resolved with analgesic drug treatment (P = 0.01). Eight patients in the first group(11 %) and five patients in the second group (7 %) had to be given major opiate analgesics (P = 0.56). Refeeding resulted in abdominal pain in five patients in group 1 and 13 in group 2 (P = 0.04). The serum amylase and lipase levels increased significantly after refeeding in group 1, but lipasemia did not increase significantly in group 2. No significant differences in post-ES complications were observed between the two groups. The mean hospital stay was significantly shorter in group 1 : 2.6 days on average, vs. 3.8 days in group 2 (P = 0.03). CONCLUSIONS: In the absence of any perforation of the digestive tract or immediate severe acute pancreatitis, early refeeding could be helpful to decrease pain and shorten the hospital stay in patients who have undergone endoscopic sphincterotomy.     

Comparison of a new unguided self-advancing jejunal tube with the endoscopic guided technique: a prospective, randomized study

Objective

To compare the success rate of correct jejunal placement of a new self-advancing jejunal tube with the gold standard, the endoscopic guided technique, in a comparative intensive care unit (ICU) patient population.

Design

Prospective, randomized study.

Setting

Two medical ICUs at a university hospital.

Patients

Forty-two mechanically ventilated patients with persisting intolerance of intragastric enteral nutrition despite prokinetic therapy.

Methods

Patients were randomly assigned to receive an unguided self-advancing jejunal feeding tube (Tiger Tube?) or an endoscopic guided jejunal tube (Freka^® Trelumina). Primary outcome measure was the success rate of correct jejunal placement after 24 h.

Results

Correct jejunal tube placement was reached in all 21 patients using the endoscopic guided technique whereas the unguided self-advancing jejunal tube could be placed successfully in 14 out of 21 patients (100% versus 67%; P = 0.0086). In the remaining seven patients, successful endoscopic jejunal tube placement was performed subsequently. Duration of tube placement was longer in the unguided self-advancing tube group (20 ± 12 min versus 597 ± 260 min; P < 0.0001). Secondary outcome parameters (complication rate, number of attempts, days in correct position with accurate functional capability, days with high gastric residual volume, length of ICU stay, ICU mortality) were not statistically different between the two groups. No potentially relevant parameter predicting the failure of correct jejunal placement of the self-advancing tube could be identified.

Conclusions

Success rate of correct jejunal placement of the new unguided self-advancing tube was significantly lower than the success rate of the endoscopic guided technique.     

A prospective multiyear study of the course of chronic recurrent pancreatitis

It was established during observation over time (within the period from 10 to 12 years) that the overwhelming majority of patients with chronic cholecystopancreatitis and primary chronic pancreatitis progressed to a different degree to enzyme-secreting pancreatic failure according to the pancreozymine tests. At the same time in 2/5 of all the cases, enzyme-secreting failure turned out substantial by the end of the indicated period. During the years of prospective studies, every tenth patient with chronic pancreatitis developed secondary diabetes mellitus. The degree of pancreatic enzyme secretion and carbohydrate metabolism abnormalities depended on the number of disease exacerbations suffered by the patient. Secondary gastroduodenal ulcers occurred in 27 out of 647 patients observed over time, and all the cases were associated with a considerable reduction of pancreatic bicarbonate secretion (according to the secretin test). Pancreatogenous pleural exudate was recorded in 1.4% of all the cases of chronic pancreatitis. During the observation period, 16 out of the 647 patients died from chronic pancreatitis associated with progressive exocrine pancreatic failure and malabsorption.     

Critical illness-related corticosteroid insufficiency in patients with severe acute biliary pancreatitis: a prospective cohort study

Introduction

Gallstones are the most common cause of acute pancreatitis worldwide. Patients with severe acute biliary pancreatitis (SABP) constitute a subgroup of severe acute pancreatitis (SAP) patients in whom systemic inflammation may be triggered and perpetuated by different mechanisms. The aim of this prospective investigation was to examine the adrenal response to corticotropin and the relationship between adrenal function and outcome in patients with SABP.

Methods

Thirty-two patients with SABP were enrolled in this study. A short corticotropin (250 μg) stimulation test (SST) was performed within the first 24 hours of admission to the ICU. Critical illness related corticosteroid insufficiency (CIRCI) was defined as follows: baseline value less than 10 μg/dL, or cortisol response less than 9 μg/dL.

Results

CIRCI occurred in 34.4% of patients. The patients with CIRCI were more severely ill as evidenced by higher APACHE II and SOFA scores and numbers of organ system dysfunction on the day of SST. The in-hospital mortality for the entire group was 21.9%. The CIRCI group had a higher hospital mortality rate compared to those with normal adrenal function (45.5% vs. 9.5%, P = 0.032). The hospital survivors had a higher cortisol response to corticotropin (17.4 (8.3–27.1) vs. 7.2 (1.7–12) μg/dL, P = 0.019). The cortisol response to corticotropin inversely correlated with SOFA score and the number of organ dysfunction on the day of SST. The rates of pancreatic necrosis and bacteremia were significantly higher in the CIRCI group (100% vs 42.9%, P = 0.002; 81.8% vs 23.8%, P = 0.003, respectively).

Conclusions

CIRCI is common in patients with SABP. It is associated with bacteremia, multiple organ dysfunction and increased mortality.     

Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study

We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% NaCl/6% hydroxyethyl starch (HT group) or 500 mL 6% hydroxyethyl starch (IT group). Hemodynamic measurements included mean arterial blood pressure (MAP), central venous pressure, stroke volume index, stroke volume variation, intrathoracic blood volume index, gastric tonometry, and sublingual microcirculatory flow as assessed by sidestream dark field imaging. Systolic tissue Doppler imaging velocities of the medial mitral annulus were measured using echocardiography to assess left ventricular contractility. Log transformation of the ratio MAP divided by the norepinephrine infusion rate (log MAP/NE) quantified the combined effect on both parameters. Compared with the IT group, hypertonic solution treatment resulted in an improvement in log MAP/NE (P = 0.008), as well as an increase in systolic tissue Doppler imaging velocities (P = 0.03) and stroke volume index (P = 0.017). No differences between the groups were found for preload parameters (central venous pressure, stroke volume variation, intrathoracic blood volume index) or for afterload parameters (systemic vascular resistance index, MAP). Hypertonic solution treatment decreased the need for ongoing fluid resuscitation (P = 0.046). No differences between groups were observed regarding tonometry or the sublingual microvascular variables. In patients with septic shock, hypertonic fluid administration did not promote gastrointestinal mucosal perfusion or sublingual microcirculatory blood flow in comparison to isotonic fluid. Independent of changes in preload or afterload, hypertonic fluid administration improved the cardiac contractility and vascular tone compared with isotonic fluid. The need for ongoing fluid resuscitation was also reduced.     

The treatment of patients with symptomatic common bile duct stenosis secondary to chronic pancreatitis using partially covered metal stents: a pilot study

BACKGROUND AND STUDY AIMS: Although surgery remains the gold standard for the treatment of symptomatic common bile duct stenosis associated with chronic pancreatitis, plastic and self-expandable open-mesh stents have been proposed as alternative treatments. These may dysfunction, however, mainly due to stent occlusion by clogging or by hyperplasia of inflammatory tissue. The aim of this study was to evaluate the safety and long-term results of using partially covered metal stents in this setting. PATIENTS AND METHODS: A total of 14 patients (12 men, 2 women; mean age 50 +/- 3 years) underwent partially covered metal stent insertion for common bile duct stenosis secondary to chronic pancreatitis (12 alcohol-related, two idiopathic). They had all been treated previously with plastic prostheses. RESULTS: Either a 40-mm (n = 13) or a 60-mm (n = 1) partially covered metal stent was placed, depending on the length of the common bile duct stenosis and the level of the cystic duct bifurcation. Stent placement was successful, with resolution of cholangitis and improvement in cholestasis, in all patients. During the median follow-up period of 22 months (range 12 - 33 months) seven patients developed dysfunction of the stent and required re-treatment. At 12, 24, and 30 months, the stent patency rates were 100 %, 40 %, and 37.5 % respectively. CONCLUSIONS: While partially covered metal stenting is safe and effective for the initial treatment of chronic pancreatitis-associated common bile duct stenosis and shows promising short-term results, long-term data show that dysfunction occurs in 50 % of cases. In light of the continued interest in nonsurgical treatment of this condition, further research is warranted to investigate new stent designs with improved long-term patency.     

Use of a polyvalent bacterial lysate in patients with recurrent respiratory tract infections: results of a prospective, placebo-controlled, randomized, double-blind study.

Respiratory tract infections (RTIs) are the most common infections in humans, and it is difficult to effectively treat patients with increased susceptibility to these ailments. LW 50020 (Luivac; Paspat oral), an oral immunomodulator consisting of the antigens of seven bacteria commonly involved in RTIs, has been developed for the induction of specific and nonspecific immune responses of the mucosa-associated lymphoid tissue. In this placebo-controlled study, the efficacy and safety of the tablet formulation of LW 50020 were evaluated in children and adults with recurrent RTIs. Tablets were taken once daily during two periods of 4 weeks each, interrupted by a treatment-free interval of 4 weeks. The main endpoint of the study, a clinical severity score that evaluated treatment benefits, was significantly lower in the second study period in patients treated with the bacterial lysate compared to patients given placebo. A comparison of the infection rates in the first and second study periods of patients treated with LW 50020 revealed a placebo-corrected reduction of 39% in children and a placebo-corrected reduction of 44% in adolescents and adults. The placebo-corrected duration of infections was shortened by 47% in children and by 55% in older patients. No serious drug-related side effects occurred. This study demonstrated that the oral bacterial immunomodulator LW 50020 is efficacious in treating patients with recurrent RTIs.     

Prevention of intestinal adhesions after laparotomy in a rat model — a randomized prospective study

We prospectively studied the effect of a foam composite containing glycerin, propylene glycol, polyol, stearine, stearate and silicone oil, which is known to form a temporary barrier layer when applied to epithelial surface, on adhesion prevention in rats. The small intestine abrasion model was used for creation of adhesions. Sixty male Sabra rats of a mean weight of 295±23 g were randomly assigned into four groups: group 1 (n =20) underwent laparotomy and abrasion; group 2 (n =20) underwent laparotomy, abrasion and intra-peritoneal instillation of the foam composite; group 3 (n =10) underwent laparotomy with abrasion and a second laparotomy with adhesiolysis 2 weeks later; and group 4 (n =10), was treated in the same way as group 3 but during the second laparotomy the foam composite was instilled intraperitoneally. All animals were relaparotomized 2 weeks (groups 1 and 2) and 4 weeks (groups 3 and 4) after the initial laparotomy for adhesion scoring performed by a blinded independent investigator using the standard 0–3 adhesion grading score. Representative specimens of small intestine and liver from animals in groups 2 and 4 were analyzed. A significantly lower mean adhesion score was noted in group 2 (1.15±0.3) compared with that of group 1 (2.65±0.1) or group 3 (2.60±0.1) (P<0.01). Group 4 had a significantly lower score (1.4±0.3) than group 3 or group 1 (P<0.05). There was no significant difference in the mean adhesion score between groups 1 and 3. Histological examination revealed no evidence of residual foam composite or adverse reaction to its use in the intestine and liver. The foam composite tested may reduce the severity of intestinal adhesions after laparotomy and may also reduce the severity of recurrent adhesions after adhesiolysis. Intraperitoneal use of this composite is safe in rats. The exact mechanism of action is unclear but may be related to the formation of a temporary microlayer that coats the injured surface of the intestine and facilitates healing without adhesion formation. Further investigation is needed to evaluate its full potential.     

Role of endoscopic ultrasonography in prevention of unnecessary endoscopic retrograde cholangiopancreatography: a prospective study of 150 patients.

OBJECTIVE: The purpose of this study was to evaluate the impact of substituting endoscopic ultrasonography (EUS) for endoscopic retrograde cholangiopancreatography (ERCP) in cases of a low to intermediate risk for choledocholithiasis. METHODS: During a 16-month period, patients who were referred for suspected choledocholithiasis, biliary colic, or acute biliary pancreatitis on the basis of alterations in liver enzyme values with or without gallstones seen on transabdominal ultrasonography were included. Endoscopic ultrasonography was performed for all patients. Patients with common bile duct stones underwent ERCP. Cholecystectomy was recommended in all patients with symptomatic gallstones. Cases were followed for 12 months. RESULTS: A total of 150 patients were included. Choledocholithiasis was diagnosed by EUS in 39 patients (26.0%) and was confirmed by ERCP in 30 (77.0%). Fifty-one patients had a normal common bile duct, and follow-up for 12 months showed no abnormalities except in 1 patient. Cholecystectomy without ERCP was recommended for the remaining 60 patients who had symptomatic gallstones or sludge. Endoscopic retrograde cholangiopancreatography was avoided by this approach in 110 patients (73.3%). CONCLUSIONS: In a low to intermediate risk for choledocholithiasis, EUS can preclude the need for ERCP in most cases.     

Pancreatic endoscopic sphincterotomy in patients with chronic pancreatitis: a single-center experience in 171 consecutive patients

BACKGROUND AND STUDY AIMS: In recent years, interest in endoscopic therapy techniques for pancreatic diseases has been constantly increasing. The aim of the present study was to assess the technical success, technique, and complications of endoscopic pancreatic sphincterotomy (EPS) in patients with chronic pancreatitis. PATIENTS AND METHODS: A total of 171 patients with chronic pancreatitis and abdominal complaints were identified in whom at least one attempt at EPS was carried out. During the procedure, sphincterotomy was carried out using a guide-wire sphincterotome or a needle-knife papillotome. Patients were followed up after EPS for at least 24 h, including clinical symptoms and laboratory data (pancreatic enzymes and hemoglobin/hematocrit). RESULTS: EPS was performed in 167 of the 171 patients (technical success rate: 97.7 %). In 24 patients (14 %), a precut technique was necessary using a needle-knife sphincterotome. Sphincterotomy-related complications were observed in seven of the 171 patients (4.1 %), including three cases of bleeding, three patients with mild pancreatitis, and one with retroduodenal perforation. All complications were managed medically. There was no treatment-related mortality. CONCLUSIONS: Endoscopic sphincterotomy of the pancreatic duct in patients with chronic pancreatitis is a fairly safe procedure with a high technical success rate.     

Endoscopic removal of biliary self-expandable metallic stents: a prospective study

BACKGROUND AND STUDY AIMS: The transpapillary endoscopic insertion of self-expandable metallic stents (SEMSs) has been widely used for the palliation of unresectable malignant biliary obstruction. We attempted the endoscopic removal of malfunctioning SEMSs. The aim of this study was to assess the feasibility and safety of the endoscopic removal of SEMSs by comparing the results between removal of covered and uncovered SEMSs. PATIENTS AND METHODS: 30 patients with a malfunctioning biliary SEMS prospectively underwent an attempt at endoscopic removal of the biliary SEMS over a 2-year period. Removal of the malfunctioning SEMS was done with a therapeutic duodenoscope (ED-450XT5 or TJF-240), using a rat-tooth forceps. Of the 30 SEMS used, 22 were silicone-covered Wallstents, while eight were uncovered SEMSs including five uncovered Wallstents and three Zilver stents. The time for an attempt at each endoscopic removal was limited to 15 minutes in a single endoscopic procedure session. RESULTS: The covered SEMSs were easily removed in 19 out of 22 patients (86.4 %), whereas none of the eight uncovered SEMSs (0 %) could be removed. The only factor predicting successful stent removal was the presence of a stent covering ( P = 0.000). There was no morbidity or mortality related to endoscopic removal of malfunctioning stents. CONCLUSIONS: In contrast to uncovered biliary SEMSs, in most cases malfunctioning covered biliary SEMSs can be easily and safely removed endoscopically using a rat-tooth forceps.     

Short-term effects of combining upright and prone positions in patients with ARDS: a prospective randomized study

Introduction  

Prone position is known to improve oxygenation in patients with acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS). Supine upright (semirecumbent) position also exerts beneficial effects on gas exchange in this group of patients. We evaluated the effect of combining upright and prone position on oxygenation and respiratory mechanics in patients with ALI or ARDS in a prospective randomized cross-over study.     

Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis using pancreatic stents: A review of efficacy,diameter and length

Although endoscopic retrograde cholangiopancreatography (ERCP) is an important procedure for the diagnosis and treatment of pancreaticobiliary diseases, post-ERCP pancreatitis (PEP) is the most frequent adverse event that can sometimes be fatal. However, prophylactic pancreatic stent (PS) insertion has been performed to prevent PEP in high-risk patients. In some randomized controlled trials (RCTs) and meta-analyses, the efficacy of prophylactic PS insertion has been shown to prevent PEP. In addition, several types of stents have been used to decrease PEP. In this review, we introduce the details of these RCTs and meta-analyses and reveal the specifications for stent placement, for example, the stent diameter and length and the pancreatic region into which the stent should be inserted.     

法莫替丁预防内镜逆行胰胆管造影术后胰腺炎的临床研究--附46例报告

目的 :探讨法莫替丁预防内镜逆行胰胆管造影 (endoscopicretrogradecholangiopan creatography ,ERCP)术后急性胰腺炎的作用。方法 :86例胆胰疾病患者分为法莫替丁组 4 6例和安慰剂组4 0例 ,分别在ERCP术前 1日和当日静脉滴注生理氯化钠 5 0 0mL加法莫替丁 2 0mg和单纯生理氯化钠 5 0 0mL ,每日 2次。术前、术后 4小时及 2 4小时分别测定血清淀粉酶并观察有无急性胰腺炎的临床表现如腹痛、呕吐、发热等。结果 :ERCP术后法莫替丁组及安慰剂组急性胰腺炎的发生率分别为 7% (3/ 4 6 )、13% (5 / 4 0 ) ,P <0 0 1;术后 4小时高淀粉酶血症的发生率分别为 30 % (14 / 4 6 )、 4 8% (19/ 4 0 ) ,P <0 0 5。术后 2 4小时两组血清淀粉酶水平差异无统计学意义。结论 :法莫替丁可减少ERCP术后急性胰腺炎的发生率