Neuropsychological and renal effects of dental amalgam in children: a randomized clinical trial

Context  No randomized trials have been published that address the concern that inhalation of mercury vapor released by amalgam dental restorations causes adverse health effects. Objective  To compare the neuropsychological and renal function of children whose dental caries were restored using amalgam or mercury-free materials. Design and Setting  The New England Children's Amalgam Trial was a 2-group randomized safety trial involving 5 community health dental clinics in Boston, Mass, and 1 in Farmington, Me, between September 1997 and March 2005. Participants and Intervention  A total of 534 children aged 6 to 10 years at baseline with no prior amalgam restorations and 2 or more posterior teeth with caries were randomly assigned to receive dental restoration of baseline and incident caries during a 5-year follow-up period using either amalgam (n=267) or resin composite (n =267) materials. Main Outcome Measures  The primary neuropsychological outcome was 5-year change in full-scale IQ scores. Secondary outcomes included tests of memory and visuomotor ability. Renal glomerular function was measured by creatinine-adjusted albumin in urine. Results  Children had a mean of 15 tooth surfaces (median, 14) restored during the 5-year period (range, 0-55). Assignment to the amalgam group was associated with a significantly higher mean urinary mercury level (0.9 vs 0.6 µg/g of creatinine at year 5, P<.001). After adjusting for randomization stratum and other covariates, no statistically significant differences were found between children in the amalgam and composite groups in 5-year change in full-scale IQ score (3.1 vs 2.1, P = .21). The difference in treatment group change scores was 1.0 (95% confidence interval, –0.6 to 2.5) full-scale IQ score point. No statistically significant differences were found for 4-year change in the general memory index (8.1 vs 7.2, P = .34), 4-year change in visuomotor composite (3.8 vs 3.7, P = .93), or year 5 urinary albumin (median, 7.5 vs 7.4 mg/g of creatinine, P = .61). Conclusions  In this study, there were no statistically significant differences in adverse neuropsychological or renal effects observed over the 5-year period in children whose caries were restored using dental amalgam or composite materials. Although it is possible that very small IQ effects cannot be ruled out, these findings suggest that the health effects of amalgam restorations in children need not be the basis of treatment decisions when choosing restorative dental materials. Trial Registration  clinicaltrials.gov Identifier: NCT00065988      

鼻喷右美托咪定在儿童口腔门诊全身麻醉前的镇静效果

目的: 观察全身麻醉下牙病治疗患儿鼻喷右美托咪定(dexmedetomidine,DEX)对术前紧张情绪、父母分离焦虑、面罩接受程度和术后躁动的影响。方法: 选择北京大学口腔医院儿童口腔门诊全身麻醉下牙病治疗的患儿60例,年龄2~9岁,随机分为2组:对照组术前30 min经鼻喷入生理盐水0.02 mL/kg,DEX组喷入DEX 2 μg/kg(药物使用原液)。观察和记录患儿给药前及给药后10、20、25、30 min的心率(heart rate,HR)、脉搏血氧饱和度(oxygen saturation,SpO₂)以及给药30 min后的Ramsay镇静评分、分离焦虑评分、面罩吸入诱导接受度评分和术后躁动评分及并发症的情况。结果: 两组患儿的年龄、体重、性别构成、手术时间、拔管时间和苏醒时间相似,差异无统计学意义。DEX组患儿与父母的分离焦虑、面罩接受程度明显优于对照组(56.7% vs. 26.7%,73.3% vs. 40%,P均<0.05),术后躁动评分在两组间差异无统计学意义(P>0.05)。与对照组相比,DEX组患儿给药20 min后HR有所下降,差异有统计学意义[(97.13±12.93)次/min vs. (104.53±11.97)次/min, P<0.05]。两组患儿的SpO₂未见明显差异,且均未见心动过缓、低氧血症的发生。结论: 全身麻醉前经鼻喷入DEX可以产生良好的术前镇静作用,改善与父母的分离焦虑,提高面罩接受度。两组患儿苏醒质量高,无明显的苏醒期躁动、呼吸抑制等并发症。鼻喷DEX 2 μg/kg是一种安全有效的儿童术前给药方式。     

Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled trial

Context  In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute lung injury. However, the effect of prone positioning on clinical outcomes in children is not known. Objective  To test the hypothesis that at the end of 28 days infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning. Design, Setting, and Patients  Multicenter, randomized, controlled clinical trial conducted from August 28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs prone positioning. Randomization was concealed and group assignment was not blinded. Intervention  Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines. Main Outcome Measure  Ventilator-free days to day 28. Results  The trial was stopped at the planned interim analysis on the basis of the prespecified futility stopping rule. There were no differences in the number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5] supine vs 15.6 [8.6] prone; mean difference, –0.2 days; 95% CI, –3.6 to 3.2; P = .91). After controlling for age, Pediatric Risk of Mortality III score, direct vs indirect acute lung injury, and mode of mechanical ventilation at enrollment, the adjusted difference in ventilator-free days was 0.3 days (95% CI, –3.0 to 3.5; P = .87). There were no differences in the secondary end points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P>.99), the time to recovery of lung injury (P = .78), organ-failure–free days (P = .88), and cognitive impairment (P = .16) or overall functional health (P = .12) at hospital discharge or on day 28. Conclusion  Prone positioning does not significantly reduce ventilator-free days or improve other clinical outcomes in pediatric patients with acute lung injury.      

Dictated versus database-generated discharge summaries: a randomized clinical trial

BACKGROUND: Hospital discharge summaries communicate information necessary for continuing patient care. They are most commonly generated by voice dictation and are often of poor quality. The objective of this study was to compare discharge summaries created by voice dictation with those generated from a clinical database. METHODS: A randomized clinical trial was performed in which discharge summaries for patients discharged from a general internal medicine service at a tertiary care teaching hospital in Ottawa were created by voice dictation (151 patients) or from a database (142 patients). Patients had been admitted between September 1996 and June 1997. The trial was preceded by a baseline cohort study in which all summaries were created by dictation. For the database group, information on forms completed by housestaff was entered into a database and collated into a discharge summary. For the dictation group, housestaff dictated narrative letters. The proportion of patients for whom a summary was generated within 4 weeks of discharge was recorded. Physicians receiving the summary rated its quality, completeness, organization and timeliness on a 100-mm visual analogue scale. Housestaff preference was also determined. RESULTS: Patients in the database group and the dictation group were similar. A summary was much more likely to be generated within 4 weeks of discharge for patients in the database group than for those in the dictation group (113 [79.6%] v. 86 [57.0%]; p < 0.001). Summary quality was similar (mean rating 72.7 [standard deviation (SD) 19.3] v. 74.9 [SD 16.6]), as were assessments of completeness (73.4 [SD 19.8] v. 78.2 [SD 14.9]), organization (77.4 [SD 16.3] v. 79.3 [SD 17.2]) and timeliness (70.3 [SD 21.9] v. 66.2 [SD 25.6]). Many information items of interest were more likely to be included in the database-generated summaries. The database system created summaries faster and was preferred by housestaff. Dictated summaries in the baseline and randomized studies were similar, which indicated that the control group was not substantially different from the baseline cohort. INTERPRETATION: The database system significantly increased the likelihood that a discharge summary was created. Housestaff preferred the database system for summary generation. Physicians thought that the quality of summaries generated by the 2 methods was similar. The use of computer databases to create hospital discharge summaries is promising and merits further study and refinement.     

Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial

Context  Combination therapy is now widely advocated as first-line treatment for uncomplicated malaria in Africa. However, it is not clear which treatment regimens are optimal or how to best assess comparative efficacies in highly endemic areas. Objective  To compare the efficacy and safety of 3 leading combination therapies for the treatment of uncomplicated malaria. Design, Setting, and Participants  Single-blind randomized clinical trial, conducted between November 2004 and June 2006, of treatment for all episodes of uncomplicated malaria in children in an urban community in Kampala, Uganda. A total of 601 healthy children (aged 1-10 years) were randomly selected and were followed up for 13 to 19 months, receiving all medical care at the study clinic. Interventions  Study participants were randomized to receive 1 of 3 combination therapies (amodiaquine plus sulfadoxine-pyrimethamine, amodiaquine plus artesunate, or artemether-lumefantrine) when diagnosed with their first episode of uncomplicated malaria. The same assigned treatment was given for all subsequent episodes. Main Outcome Measure  28-Day risk of parasitological failure (unadjusted and adjusted by genotyping to distinguish recrudescence from new infection) for each episode of uncomplicated malaria treated with study drugs. Results  Of enrolled children, 329 of 601 were diagnosed with at least 1 episode of uncomplicated malaria, and 687 episodes of Plasmodium falciparum malaria were treated with study drugs. The 28-day risk of treatment failure (unadjusted by genotyping) for individual episodes of malaria were 26.1% (95% CI, 21.1%-32.1%) for amodiaquine plus sulfadoxine-pyrimethamine, 17.4% (95% CI, 13.1%-23.1%) for amodiaquine plus artesunate, and 6.7% (95% CI, 3.9%-11.2%) for artemether-lumefantrine (P<.05 for all pairwise comparisons). When only recrudescent treatment failures were considered, the risks of failure were 14.1% (95% CI, 10.3%-19.2%), 4.6% (95% CI, 2.5%-8.3%), and 1.0% (95% CI, 0.3%-4.0%) for the same order of study drugs, respectively (P.008 for all pairwise comparisons, except amodiaquine plus artesunate vs artemether-lumefantrine, P = .05). There were no deaths or cases of severe malaria. Significant reductions in anemia (9.3% [95% CI, 7.0%-12.0%] at enrollment vs 0.6% [95% CI, 0.1%-2.2%] during the last 2 months of follow-up; P<.001) and asymptomatic parasitemia (18.6% [95% CI, 15.5%-22.1%] at enrollment vs 2.3% [95% CI, 1.5%-3.5%] during the last 2 months of follow-up; P<.001) were observed according to routine testing. Conclusions  Artemether-lumefantrine was the most efficacious treatment for uncomplicated malaria in the study population. With all study regimens, the provision of prompt and reasonably effective facility-based treatment was associated with good outcomes in long-term health measures. Trial Registration  isrctn.org Identifier: ISRCTN37517549      

一次性包皮切割缝合器在儿童包皮环切术中的疗效：前瞻性随机对照研究

目的探讨一次性包皮切割缝合器在儿童包皮环切术中的优势。方法前瞻性研究入组我院门诊就诊的包茎和包皮过长 并行包皮环切术的儿童,随机分成包皮切割缝合器组和传统包皮环切手术组;共纳入236例男童,其中一次性包皮切割缝合器 组132例,传统手术方式104例。通过评估两种手术方式局部麻醉方式占比,手术时间,术中出血量,术中和术后疼痛评分,术后 阴茎外观满意率,术后并发症发生率,切口愈合时间,术后总体满意率的差异;比较一次性包皮切割缝合器在儿童包皮环切术中 的优势。结果与传统包皮环切术组对比,包皮切割缝合器组具有局麻方式占比高（P<0.001）,手术时间短（P<0.001）,术中出血 少（P<0.001）,术中和术后疼痛更轻（P<0.001）,术后切口愈合时间短（P<0.001）,术后阴茎外观满意率更高（P=0.03）,术后并发 症发生率更低（P=0.04）,切口愈合时间更短（P<0.001）,总体满意度更高（P<0.005）等优点。结论使用一次性包皮切割缝合器 的包皮环切术具有手术时间短、局麻耐受性好,围手术期疼痛轻、恢复快及术后外观漂亮等显著优势,更易于儿童及家长接受, 值得临床广泛应用。     

Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial

Context  Despite a stage-shift to earlier cancer stages and lower tumor volumes for prostate cancer, pathologically advanced disease is detected at radical prostatectomy in 38% to 52% of patients. However, the optimal management of these patients after radical prostatectomy is unknown. Objective  To determine whether adjuvant radiotherapy improves metastasis-free survival in patients with stage pT3 N0 M0 prostate cancer. Design, Setting, and Patients  Randomized, prospective, multi-institutional, US clinical trial with enrollment between August 15, 1988, and January 1, 1997 (with database frozen for statistical analysis on September 21, 2005). Patients were 425 men with pathologically advanced prostate cancer who had undergone radical prostatectomy. Intervention  Men were randomly assigned to receive 60 to 64 Gy of external beam radiotherapy delivered to the prostatic fossa (n = 214) or usual care plus observation (n = 211). Main Outcome Measures  Primary outcome was metastasis-free survival, defined as time to first occurrence of metastatic disease or death due to any cause. Secondary outcomes included prostate-specific antigen (PSA) relapse, recurrence-free survival, overall survival, freedom from hormonal therapy, and postoperative complications. Results  Among the 425 men, median follow-up was 10.6 years (interquartile range, 9.2-12.7 years). For metastasis-free survival, 76 (35.5%) of 214 men in the adjuvant radiotherapy group were diagnosed with metastatic disease or died (median metastasis-free estimate, 14.7 years), compared with 91 (43.1%) of 211 (median metastasis-free estimate, 13.2 years) of those in the observation group (hazard ratio [HR], 0.75; 95% CI, 0.55-1.02; P = .06). There were no significant between-group differences for overall survival (71 deaths, median survival of 14.7 years for radiotherapy vs 83 deaths, median survival of 13.8 years for observation; HR, 0.80; 95% CI, 0.58-1.09; P = .16). PSA relapse (median PSA relapse–free survival, 10.3 years for radiotherapy vs 3.1 years for observation; HR, 0.43; 95% CI, 0.31-0.58; P<.001) and disease recurrence (median recurrence-free survival, 13.8 years for radiotherapy vs 9.9 years for observation; HR, 0.62; 95% CI, 0.46-0.82; P = .001) were both significantly reduced with radiotherapy. Adverse effects were more common with radiotherapy vs observation (23.8% vs 11.9%), including rectal complications (3.3% vs 0%), urethral strictures (17.8% vs 9.5%), and total urinary incontinence (6.5% vs 2.8%). Conclusions  In men who had undergone radical prostatectomy for pathologically advanced prostate cancer, adjuvant radiotherapy resulted in significantly reduced risk of PSA relapse and disease recurrence, although the improvements in metastasis-free survival and overall survival were not statistically significant. Trial Registration  clinicaltrials.gov Identifier: NCT00394511      

利福昔明片与环丙沙星片随机、单盲对照治疗急性细菌感染性腹泻的临床疗效观察

目的:评价国产利福昔明治疗细菌感染性腹泻的疗效和安全性.方法:采用随机、单盲对照试验,以国产环丙沙星作对照,研究利福昔明治疗细菌感染性腹泻的效果.利福昔明第1日每次0.4g,1日3次,第2日起每次0.4g,1日2次;环丙沙星第1日每次0.25g,1日3次,第2日起每次0.25g,1日2次,疗程均为3～7天.治疗前后查血、尿、大便常规,肝功、肾功生化和心电图用于安全性评价.结果:利福昔明组29例,环丙沙星组25例,其中35例治疗前分离到病原菌,细菌阳性率为64.8%.临床有效率和临床痊愈率分别为100%和91.3%,两组临床有效率和临床痊愈率无统计学差异.细菌清除率分别为100%和87.5%,亦无统计学差异.两组未观察到不良反应的发生.结论:利福昔明片治疗细菌感染性腹泻的临床疗效肯定,不良反应少,可在细菌感染性腹泻治疗中应用.     

Labor analgesia with ropivacaine added to clonidine: a randomized clinical trial

CONTEXT AND OBJECTIVE: Previous studies have led to speculation that the association between ropivacaine and clonidine might be more effective than ropivacaine alone. We examined the maternal-fetal effects of two pharmacological approaches: a low dose of ropivacaine or a lower dose of ropivacaine plus clonidine for epidural analgesia during labor. DESIGN AND SETTING: Prospective study at Department of Anesthesiology, Faculdade de Medicina de Botucatu, Universidade Estadual Paulista. METHODS: Thirty-two pregnant women in American Society of Anesthesiologists physical status I and II randomly underwent epidural analgesia using 15 ml of ropivacaine 0.125% (R group) or 15 ml of ropivacaine 0.0625% plus 75 microg clonidine (RC group). Pain intensity, sensory block level, latency time, motor block intensity, duration of labor analgesia and duration of epidural analgesia were evaluated. The newborns were evaluated using Apgar scores and the Amiel-Tison method (neurological and adaptive capacity score). RESULTS: There were no statistically significant differences between the groups regarding pain score, sensory block level, duration of epidural analgesia or Apgar score. The latency time, duration of labor analgesia and motor block were R group < RC group. The half-hour and two-hour neurological and adaptive capacity scores were higher in the R group. All of the R group newborns and 75% of the RC group newborns were found to be neurologically healthy at the 24-hour examination. RESULTS: There were no statistically significant differences between the groups regarding pain score, sensory block level, duration of epidural analgesia or Apgar score. The latency time, duration of labor analgesia and motor block were R group < RC group. The half-hour and two-hour neurological and adaptive capacity scores were higher in the R group. All of the R group newborns and 75% of the RC group newborns were found to be neurologically healthy at the 24-hour examination. CONCLUSION: Both low-dose ropivacaine and a lower dose plus clonidine relieved maternal pain during obstetric labor. Newborns of mothers who received only ropivacaine showed better neurological and adaptive capacity scores.     

Folic acid for the prevention of colorectal adenomas: a randomized clinical trial

Context  Laboratory and epidemiological data suggest that folic acid may have an antineoplastic effect in the large intestine. Objective  To assess the safety and efficacy of folic acid supplementation for preventing colorectal adenomas. Design, Setting, and Participants  A double-blind, placebo-controlled, 2-factor, phase 3, randomized clinical trial conducted at 9 clinical centers between July 6, 1994, and October 1, 2004. Participants included 1021 men and women with a recent history of colorectal adenomas and no previous invasive large intestine carcinoma. Intervention  Participants were randomly assigned in a 1:1 ratio to receive 1 mg/d of folic acid (n = 516) or placebo (n = 505), and were separately randomized to receive aspirin (81 or 325 mg/d) or placebo. Follow-up consisted of 2 colonoscopic surveillance cycles (the first interval was at 3 years and the second at 3 or 5 years later). Main Outcome Measures  The primary outcome measure was occurrence of at least 1 colorectal adenoma. Secondary outcomes were the occurrence of advanced lesions (25% villous features, high-grade dysplasia, size 1 cm, or invasive cancer) and adenoma multiplicity (0, 1-2, or 3 adenomas). Results  During the first 3 years, 987 participants (96.7%) underwent colonoscopic follow-up, and the incidence of at least 1 colorectal adenoma was 44.1% for folic acid (n = 221) and 42.4% for placebo (n = 206) (unadjusted risk ratio [RR], 1.04; 95% confidence interval [CI], 0.90-1.20; P = .58). Incidence of at least 1 advanced lesion was 11.4% for folic acid (n = 57) and 8.6% for placebo (n = 42) (unadjusted RR, 1.32; 95% CI, 0.90-1.92; P = .15). A total of 607 participants (59.5%) underwent a second follow-up, and the incidence of at least 1 colorectal adenoma was 41.9% for folic acid (n = 127) and 37.2% for placebo (n = 113) (unadjusted RR, 1.13; 95% CI, 0.93-1.37; P = .23); and incidence of at least 1 advanced lesion was 11.6% for folic acid (n = 35) and 6.9% for placebo (n = 21) (unadjusted RR, 1.67; 95% CI, 1.00-2.80; P = .05). Folic acid was associated with higher risks of having 3 or more adenomas and of noncolorectal cancers. There was no significant effect modification by sex, age, smoking, alcohol use, body mass index, baseline plasma folate, or aspirin allocation. Conclusions  Folic acid at 1 mg/d does not reduce colorectal adenoma risk. Further research is needed to investigate the possibility that folic acid supplementation might increase the risk of colorectal neoplasia. Trial Registration  clinicaltrials.gov Identifier: NCT00272324      

Anabolic effects of nandrolone decanoate in patients receiving dialysis: a randomized controlled trial

CONTEXT: Patients receiving dialysis commonly experience malnutrition, reduced muscle mass (sarcopenia), and fatigue for which no effective treatment has been identified. Anabolic steroids are known to increase muscle mass and strength in healthy individuals, but their effect on the sarcopenia and fatigue associated with long-term dialysis has not been evaluated. OBJECTIVE: To assess the effects of an anabolic steroid, nandrolone decanoate, on lean body mass (LBM), functional status, and quality of life in dialysis patients. DESIGN: Randomized, double-blind, placebo-controlled trial conducted between April 1996 and July 1997. SETTING: Hospital-based outpatient dialysis unit. PATIENTS: Twenty-nine patients undergoing dialysis for at least 3 months. INTERVENTION: Nandrolone decanoate, 100 mg (n = 14), or placebo (n = 15) by intramuscular injection once a week for 6 months. MAIN OUTCOME MEASURES: Weight, LBM, fatigue, grip strength, walking and stair-climbing times, and treadmill performance after 3 and 6 months of treatment. RESULTS: Lean body mass increased significantly in patients given nandrolone compared with patients given placebo (mean change [SD], +4.5 [2.3] kg; P<.001 compared with baseline). This effect was significantly greater than the change in LBM in the placebo group (mean change [SD], +1.9 [1.6] kg; P = .003 compared with baseline; P = .005 compared with nandrolone group). Serum creatinine levels increased in the nandrolone group (+168 [203] mmol/L [1.9 [2.3] mg/dL]; P = .02) but not in the placebo group (-4.0 [177] mmol/L [0.04 [2.0] mg/dL]; P = .95), suggesting an increase in muscle mass. Time to complete the walking and stair-climbing test decreased from 36.5 to 32.7 seconds in the nandrolone group, while those in the placebo group increased from 38.7 to 42.1 seconds (P = .05). Peak oxygen consumption increased in the individuals in the nandrolone group who performed treadmill tests, but not to a statistically significant degree. Grip strength did not change in either group. CONCLUSIONS: Treatment with nandrolone for 6 months resulted in a significant increase in LBM associated with functional improvement in patients undergoing dialysis.     

不同气腹压下腹腔镜胆囊切除术疗效的meta分析

 目的 评价腹腔镜胆囊切除术（laparoscopic cholecystectomy,LC）过程中低压气腹（low pressure pneumoperitoneum,LP）的安全性及有效性。方法 本研究从MEDLINE、EMBASE、ISI数据库、Cochrane Library、CBM、VIP、CNKI以及万方数据库检索并纳入了在1987年1月至2009年12月间发表的LP下LC的随机对照试验,语种不限,并对纳入研究的方法学质量进行评价,最后用RevMan 5.0软件进行分析。结果 共纳入7个英文随机对照试验（randomized controlled trials,RCT）,包括518例患者。与传统的标准气腹压（standard pneumoperitoneum,SP）下LC相比,LP下行LC明显减少术后肩痛发生率（RR为0.50,95%CI为0.37,0.68）、缩短住院时间（WMD为-0.13,95%CI为-0.23,-0.02）;手术安全性评价上,LP组和SP组间的差异无统计学意义（RR为0.84,95%CI为0.46,1.54）;两组的手术时间相当（WMD为1.54,95%CI为-0.85,3.76）。结论 LP下行LC是安全有效的,更具微创优势。     

Hospital-acquired complications in a randomized controlled clinical trial of a geriatric consultation team

As part of a controlled clinical trial of a geriatric consultation team (GCT), we investigated whether a GCT could affect the incidence of hospital-acquired complications in elderly patients. One hundred eighty-five patients, aged 75 years and older, were randomized into an intervention (N = 92) and a control (N = 93) group. Members of the intervention group received a GCT consultation and were routinely followed up throughout their hospitalization. The incidence of hospital-acquired complications for the entire study population was 38%. The type and rate of hospital-acquired complications in the intervention and control groups were not significantly different. Functional status on admission and admission to the psychiatry service were predictive for the occurrence of a hospital-acquired complication. In a broadly selected population such as this, the intensity of care available through a GCT was unable to reduce the occurrence of hospital-acquired complications. However, since this is only one aspect of a GCT function, and others may be of great importance, such aspects, and more targeted populations, must be evaluated before final conclusions can be reached about GCT efficiency.