Randomized-controlled Multicenter Study Research Articles

Direct assessment of microcirculation in shock: a randomized-controlled multicenter study

PurposeShock is a life-threatening condition characterized by substantial alterations in the microcirculation. This study tests the hypothesis that considering sublingual microcirculatory perfusion variables in the therapeutic management reduces 30-day mortality in patients admitted to the intensive care unit (ICU) with shock.MethodsThis randomized, prospective clinical multicenter trial-recruited patients with an arterial lactate value above two mmol/L, requiring vasopressors despite adequate fluid resuscitation, regardless of the cause of shock. All patients received sequential sublingual measurements using a sidestream-dark field (SDF) video microscope at admission to the intensive care unit (± 4 h) and 24 (± 4) hours later that was performed blindly to the treatment team. Patients were randomized to usual routine or to integrating sublingual microcirculatory perfusion variables in the therapy plan. The primary endpoint was 30-day mortality, secondary endpoints were length of stay on the ICU and the hospital, and 6-months mortality.ResultsOverall, we included 141 patients with cardiogenic (n = 77), post cardiac surgery (n = 27), or septic shock (n = 22). 69 patients were randomized to the intervention and 72 to routine care. No serious adverse events (SAEs) occurred. In the interventional group, significantly more patients received an adjustment (increase or decrease) in vasoactive drugs or fluids (66.7% vs. 41.8%, p = 0.009) within the next hour. Microcirculatory values 24 h after admission and 30-day mortality did not differ [crude: 32 (47.1%) patients versus 25 (34.7%), relative risk (RR) 1.39 (0.91–1.97); Cox-regression: hazard ratio (HR) 1.54 (95% confidence interval (CI) 0.90–2.66, p = 0.118)].ConclusionIntegrating sublingual microcirculatory perfusion variables in the therapy plan resulted in treatment changes that do not improve survival at all.Graphical

Effects of probiotics (cultured Lactobacillus subtilis/Streptococcus faecium) in the treatment of alcoholic hepatitis: randomized-controlled multicenter study.

Probiotics might reduce gut-derived microbial lipopolysaccharide (LPS) by restoring bowel flora in patients with alcoholic hepatitis (AH). We evaluated the therapeutic effects of probiotics in patients with AH. Between September 2010 and April 2012, 117 patients (probiotics 60 and placebo 57) were prospectively randomized to receive the 7 days of cultured Lactobacillus subtilis/Streptococcus faecium (1500 mg/day) or placebo. All patients were hospitalized and were not permitted to consume alcohol for the 7 days of the study. Liver function test, proinflammatory cytokines, LPS, and colony-forming units by stool culture were examined and compared after therapy. In both groups, the mean levels of aspartate aminotransferase/alanine aminotransferase, alkaline phosphatase, γ-glutamyl transpeptidase, bilirubin, and prothrombin time were significantly improved after 7 days of abstinence. In the probiotics group (baseline and after), albumin (3.5 ± 0.7 and 3.7 ± 0.6 g/dl, P=0.038) and tumor necrosis factor-α (121 ± 244 and 71 ± 123 pg/ml, P=0.047) showed differences. In addition, the number of colony-forming units of Escherichia coli was significantly reduced (435 ± 287 and 168 ± 210, P=0.002). In the placebo group, the level of LPS (1.7 ± 2.8 and 2.0 ± 2.7 EU/ml) was significantly increased. In the intergroup comparison, significant differences in the levels of tumor necrosis factor-α (P=0.042) and LPS (P=0.028) were observed between the groups. Immediate abstinence is the most important treatment for patients with AH. In addition, 7 days of oral supplementation with cultured L. subtilis/S. faecium was associated with restoration of bowel flora and improvement of LPS in patients with AH.

A prospective, randomized, controlled study using OsseoSpeed™ implants placed in maxillary fresh extraction socket: soft tissues response

The aim of this work was to study the peri-implant soft tissues response, by evaluating both the recession and the papilla indexes, of patients treated with implants with two different configurations. In addition, data were stratified by tooth category, smoking habit and thickness of buccal bone wall. The clinical trial was designed as a prospective, randomized-controlled multicenter study. Adults in need of one or more implants replacing teeth to be removed in the maxilla within the region 15-25 were recruited. Following tooth extraction, the site was randomly allocated to receive either a cylindrical or conical/cylindrical implant. The following parameters were studied: (i) Soft tissue recession (REC) measured by comparing the gingival zenith (GZ) score at baseline (permanent restoration) with that of the yearly follow-up visits over a period of 3 years (V1, V2 and V3). (ii) Interdental Papilla Index (PI): PI measurements were performed at baseline and compared with that of the follow-up visits. In addition, data were stratified by different variables: tooth category: anterior (incisors and canine) and posterior (first and second premolar); smoking habit: patient smoker (habitual or occasional smoker at inclusion) or non-smoker (non-smoker or ex-smoker at inclusion) and thickness of buccal bone wall (TB): TB ≤ 1 mm (thin buccal wall) or TB > 1 mm (thick buccal wall). A total of 93 patients were treated with 93 implants. At the surgical re-entry one implant was mobile and then removed; moreover, one patient was lost to follow-up. Ninety-one patients were restored with 91 implant-supported permanent single crowns. After the 3-year follow-up, a mean gain of 0.23 mm of GZ was measured; moreover, 79% and 72% of mesial and distal papillae were classified as >50%/ complete, respectively. From the stratification analysis, not significant differences were found between the mean GZ scores of implants with TB ≤ 1 mm (thin buccal wall) and TB > 1 mm (thick buccal wall), respectively (P < 0.05, Mann-Whitney U-test) at baseline, at V1, V2 and V3 follow-up visits. Also, the other variables did not seem to influence GZ changes over the follow-up period. Moreover, a re-growth of the interproximal mesial and distal papillae was the general trend observed independently from the variables studied. Immediate single implant treatment may be considered a predictable option regarding soft tissue stability over a period of 3 years of follow-up. An overall buccal soft tissue stability was observed during the GZ changes from the baseline to the 3 years of follow-up with a mean GZ reduction of 0.23 mm. A nearly full papillary re-growth can be detectable over a minimum period of 2 years of follow-up for both cylindrical and conical/cylindrical implants. Both the interproximal papilla filling and the midfacial mucosa stability were not influenced by variables such as type of fixture configuration, tooth category, smoke habit, and thickness of buccal bone wall of ≤ 1 mm (thin buccal wall).

Trabajar con hijos de familias drogodependientes: la intervención de grupo TRAMPOLINE radicada en la comunidad

Introduction: Children from substance-affected families show an elevated risk for developing own substance-related or other mental disorders. Frequently, they experience violence, abuse and neglect in their families. Therefore, they are an important target group for preventive efforts. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated program for children from substance-affected families exists in Germany. Methods: A new group intervention for children from substance-affected families was developed and is currently being evaluated in a randomized-controlled multicenter study funded by the German Ministry of Health. The development process was simultaneously guided by theory, existing research knowledge and expert opinion. Promoting resilience in children affected by parental substance abuse is a key goal of the program. Results: The TRAMPOLINE manual describes a 9-session addiction-focused, modular group program for children aged 8 to 12 years with at least one substance-using parent. Weekly sessions last for 90 minutes and combine psychoeducational elements with exercises and role play. A two-session parent intervention component is also integrated in the program. Content, structure and theoretical background of the intervention are described. Discussion: TRAMPOLINE is a new interventive effort targeting children from substance-affected families. It is grounded in theory and practice. The results of the research in progress will provide fundamental information on the effectiveness of a structured group prevention program for German children from substance-abusing families. Thus, the study will contribute to creating a broader and more effective system of preventive help for this high-risk target group.

Trabajar con hijos de familias afectadas por toxicodependencias: la intervencion grupal comunitaria TRAMPOLINE = Working with children from substance-affected families: the community-based group intervention TRAMPOLINE

Introduction:Children from substance-affected families show an elevated risk for developing own substance-related or other mental disorders. Frequently, they experience violence, abuse and neglect in their families. Therefore, they are an important target group for preventive efforts. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated program for children from substance-affected families exists in Germany.Methods: A new group intervention for children from substance-affected families was developed and is currently being evaluated in a randomized-controlled multicenter study funded by the GermanMinistry of Health. The development process was simultaneously guided by theory, existing research knowledge and expert opinion. Promoting resilience in children affected by parental substance abuse is a key goal of the program. Results: The TRAMPOLINE manual describes a 9-session addiction-focused,modulargroupprogram for children aged8 to 12 yearswith at least one substance-using parent. Weekly sessions last for 90 minutes and combine psychoeducational elements with exercises and role play. A two-session parent intervention component is also integrated in the program. Content, structure and theoretical background of the intervention are described. Discussion: TRAMPOLINE is a new interventive effort targeting children from substance-affected families. It is grounded in theory and practice. The results of the research in progress will provide fundamental information on the effectiveness of a structured group prevention program for German children from substance-abusing families. Thus, the study will contribute to creating a broader andmore effective system of preventive help for this high-risk target group.

Immediate and early non‐occlusal loading of Straumann implants with a chemically modified surface (SLActive) in the posterior mandible and maxilla: interim results from a prospective multicenter randomized‐controlled study

Immediate and early loading of dental implants can simplify treatment and increase overall patient satisfaction. The purpose of this 3-year prospective randomized-controlled multicenter study was to assess the differences in survival rates and bone level changes between immediately and early-loaded implants with a new chemically modified surface (SLActive). This investigation shows interim results obtained after 5 months. Patients > or =18 years of age missing at least one tooth in the posterior maxilla or mandible were enrolled in the study. Following implant placement, patients received a temporary restoration either on the day of surgery (immediate loading) or 28-34 days after surgery (early loading); restorations consisted of single crowns or two to four unit fixed dental prostheses. Permanent restorations were placed 20-23 weeks following surgery. The primary efficacy variable was change in bone level (assessed by standardized radiographs) from baseline to 5 months; secondary variables included implant survival and success rates. A total of 266 patients were enrolled (118 males and 148 females), and a total of 383 implants were placed (197 and 186 in the immediate and early loading groups, respectively). Mean patient age was 46.3+/-12.8 years. After 5 months, implant survival rates were 98% in the immediate group and 97% in the early group. Mean bone level change from baseline was 0.81+/-0.89 mm in the immediate group and 0.56+/-0.73 mm in the early group (P<0.05). Statistical analysis revealed a significant center effect (P<0.0001) and a significant treatment x center interaction (P=0.008). The results suggested that Straumann implants with an SLActive can be used predictably in time-critical (early or immediate) loading treatment protocols when appropriate patient selection criteria are observed. The mean bone level changes observed from baseline to 5 months (0.56 and 0.81 mm) corresponded to physiological observations from other studies, i.e., were not clinically significant. The presence of a significant center effect and treatment x center interaction indicated that the differences in bone level changes between the two groups were center dependent.