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Trial Registration (trial + registration)
Selected AbstractsLactate concentrations in the rectal lumen in patients in early septic shockACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 7 2010M. IBSEN Background: Previously, we observed that rectal luminal lactate was higher in non-survivors compared with survivors of severe sepsis or septic shock persisting >24 h. The present study was initiated to further investigate this tentative association between rectal luminal lactate and mortality in a larger population of patients in early septic shock. Methods: A prospective observational multicentre study of 130 patients with septic shock at six general ICU's of university hospitals. Six to 24 h after the onset of septic shock, the concentration of lactate in the rectal lumen was estimated by a 4-h equilibrium dialysis. Dialysate concentrations of lactate were determined using an auto-analyser. Results: The overall 30-day mortality was 32%, with age and Simplified acute physiology scores II and sequential organ failure assessment scores being significantly higher in non-survivors. In contrast, there were no differences in concentrations of lactate in the rectal lumen [2.2 (1.4,4.1) and 2.8 (1.6,5.1) mmol/l (P=0.34)] (medians and 25th,75th percentiles) or arterial blood [2.1 (1.4,4.2) and 2.0 (1.3,3.2) mmol/l (P=0.15)] between non-survivors and survivors. The rectal,arterial difference of the lactate concentration was higher in survivors. There were no differences in blood pressure, noradrenaline dose or central venous oxygen saturation between the groups. Conclusion: In this prospective, observational study of unselected patients with early septic shock, there was no difference in the concentration of lactate in the rectal lumen between non-survivors and survivors. Trial Registration: Clinicaltrials.gov (no: NCT00197938). [source] Time course of rocuronium-induced neuromuscular block after pre-treatment with magnesium sulphate: a randomised studyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 3 2010C. CZARNETZKI Background: A previously published study suggested that pre-treatment with magnesium sulphate (MgSO4) had no impact on the speed of onset of rocuronium-induced neuromuscular block. We set out to verify this assumption. Methods: Eighty patients (18,60 years) were randomly allocated to MgSO4 60 mg/kg or placebo (saline). Study drugs were given intravenously for 15 min before induction of anaesthesia with propofol, sufentanil and rocuronium 0.6 mg/kg. Anaesthesia was maintained with a target-controlled propofol infusion. Neuromuscular transmission was measured using train-of-four (TOF)-Watch SX® acceleromyography. Results: Onset was analysed in 37 MgSO4 and 38 saline patients, and recovery in 35 MgSO4 and 37 saline patients. Onset time (to 95% depression of T1) was on average 77 [SD=18] s with MgSO4 and 120 [48] s with saline (P<0.001). The total recovery time (DurTOF0.9) was on average 73.2 [22] min with MgSO4 and 57.8 [14.2] min with saline (P<0.003). The clinical duration (Dur25%) was on average 44.7 [14] min with MgSO4 and 33.2 [8.1] min with saline (P<0.0002). The recovery index (Dur25,75%) was on average 14.0 [6] min with MgSO4 and 11.2 [5.2] min with saline (P<0.02). The recovery time (Dur25%TOF0.9) was on average 28.5 [11.7] min with MgSO4 and 24.7 [8.4] min with saline (P=0.28). Conclusion: Magnesium sulphate given 15 min before propofol anaesthesia reduces the onset time of rocuronium by about 35% and prolongs the total recovery time by about 25%. Trial Registration: Clinicaltrials.gov identifier: NCT00405977. [source] Development and Validation of a Risk Scoring Model to Predict Net Adverse Cardiovascular Outcomes after Primary Percutaneous Coronary Intervention in Patients Pretreated with 600 mg Clopidogrel: Rationale and Design of the RISK-PCI StudyJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2009IGOR MRDOVIC M.D., Ph.D Background: No comprehensive primary PCI (pPCI) risk model to predict net adverse cardiovascular events (NACE) has been reported with the use of clopidogrel 600 mg, which is now considered the standard loading dose. The primary hypothesis of the RISK-PCI trial is that an accurate risk prediction may be achieved by using clinical, angiographic, and procedural variables available at the time of intervention. Methods: The present single-center, longitudinal, cohort study will include 1,750 consecutive patients with ST-elevation myocardial infarction (STEMI), undergoing pPCI after pretreatment with 300 mg aspirin and 600 mg clopidogrel. The primary end-points of the trial (NACE) include major adverse cardiovascular events (MACE) and major bleeding. A logistic regression model will be developed to predict 30-day and 1-year NACE after pPCI. A risk score derived from study set data will be validated using validation set data. Results: Until June 1, 2008, 1,166 patients have been enrolled. Thirty-day follow-up is available in 1,007 patients. Conclusions: The RISK-PCI study is designed to develop an accurate risk scoring system, using variables available at the time of intervention, to predict long-term adverse outcomes after pPCI. Trial Registration: Current Controlled Trials Register,ISRCTN83474650,http://www.controlled-trials.com/ISRCTN83474650). [source] Assessment of registration quality of trials sponsored by ChinaJOURNAL OF EVIDENCE BASED MEDICINE, Issue 1 2009Xuemei Liu Abstract Objective To evaluate the quality of the registration information for trials sponsored by China registered in the WHO primary registries or other registries that meet the requirements of the International Committee of Medical Journal Editors (ICMJE). Methods We assessed the registration information for trials registered in the 9 WHO primary registries and one other registry that met the requirements of ICJME as of 15 October 2008. We analyzed the trial registration data set in each registry and assessed the registration quality against the WHO Trial Registration Data Set (TRDS). We also evaluated the quality of the information in the Source(s) of Monetary or Material Support section, using a specially prepared scale. Results The entries in four registries met the 20 items of the WHO TRDS. These were the Chinese Clinical Trial Registration Center (ChiCR), Australian New Zealand Clinical Trials Registry (NZCTR), Clinical Trials Registry , India (CTRI), and Sri Lanka Clinical Trials Registry (SLCTR). Registration quality varied among the different registries. For example, using the Scale of TRDS, the NZCTR scored a median of 19 points, ChiCTR (median = 18 points), ISRCTN.org (median = 17 points), and Clinical trials.org (median = 12 points). The data on monetary or material support for ChiCTR and ISRCTN.org were relatively complete and the score on our Scale for the Completeness of Funding Registration Quality ranged from ChiCTR (median = 7 points), ISRCTN.org (median = 6 points), NZCTR (median = 3 points) to clinicaltrials.gov (median = 2 points). Conclusion Further improvements are needed in both the quantity and quality of trial registration. This could be achieved by full completion of the 20 items of the WHO TRDS. Future research should assess ways to ensure the quality and scope of research registration and the role of mandatory registration of funded research. [source] Prospective Registration of Clinical Trials in India: Strategies, Achievements & ChallengesJOURNAL OF EVIDENCE BASED MEDICINE, Issue 1 2009Prathap Tharyan Abstract Objective This paper traces the development of the Clinical Trial Registry-India (CTRI) against the backdrop of the inequities in healthcare and the limitations in the design, conduct, regulation, oversight and reporting of clinical trials in India. It describes the scope and goals of the CTRI, the data elements it seeks and the process of registering clinical trials. It reports progress in trial registration in India and discusses the challenges in ensuring that healthcare decisions are informed by all the evidence. Methods A descriptive survey of developments in clinical trial registration in India from publications in the Indian medical literature supplemented by firsthand knowledge of these developments and an evaluation of how well clinical trials registered in the CTRI up to 10 January, 2009 comply with the requirements of the CTRI and the World Health Organization's International Clinical Trial Registry (WHO ICTRP). Results Considerable inequities exist within the Indian health system. Deficiencies in healthcare provision and uneven regulation of, and access to, affordable healthcare co-exists with a large private health system of uneven quality. India is now a preferred destination for outsourced clinical trials but is plagued by poor ethical oversight of the many trial sites and scant information of their existence. The CTRI's vision of conforming to international requirements for transparency and accountability but also using trial registration as a means of improving trial design, conduct and reporting led to the selection of registry-specific dataset items in addition to those endorsed by the WHO ICTRP. Compliance with these requirements is good for the trials currently registered but these trials represent only a fraction of the trials in progress in India. Conclusion Prospective trial registration is a reality in India. The challenges facing the CTRI include better engagement with key stakeholders to ensure increased prospective registration of clinical trials and utilization of existing legislative opportunities to complement these efforts. [source] The Editor as umpire: clinical trial registration and dispute resolutionANAESTHESIA, Issue 12 2006D.G. Bogod Editor-in-Chief No abstract is available for this article. [source] | ||||||||||