共查询到20条相似文献,搜索用时 15 毫秒
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Przybelski RJ Daily EK Micheels J Sloan E Mols P Corne L Koenigsberg MD Bickell WH Thompson DR Harviel JD Cohn SM 《Prehospital and disaster medicine》1999,14(4):251-264
OBJECTIVE: To determine the safety and possible efficacy of diaspirin cross-linked hemoglobin (DCLHb) in the treatment of patients in Class II-IV hemorrhagic, hypovolemic shock. DESIGN: Multicenter, randomized, normal saline-controlled, dose-escalation study. SETTING: Eleven hospitals in the U.S. and Belgium. SUBJECTS: One hundred and thirty-nine (139) hospitalized patients with Class II-IV hemorrhagic, hypovolemic shock within the previous 4 hours who still were requiring therapy for shock. INTERVENTIONS: Beginning with the lowest dose, patients were randomized to receive 50, 100, or 200 mL of either 10% DCLHb or normal saline infused intravenously over 15 minutes. Following infusion of either treatment, further fluid resuscitation could be given, as necessary, to maintain perfusion. Vital signs, laboratory assessments, blood and fluid administration, complications, and adverse events were recorded at various times from the end of infusion through 72 hours after infusion. RESULTS: A total of 29 (13 DCLHb- and 16 saline-treated) patients died during the study period. Adverse events were experienced by 61% of patients in the DCLHb group and 53% of patients in the saline group; serious adverse events occurred in 28% of DCLHb-treated patients and 30% of saline-treated patients. The incidence of prospectively defined, clinical complications, including renal insufficiency and renal failure, was similar between the treatment groups except for the occurrence of dysrhythmias/conduction disorders, which occurred significantly more frequently in the saline-treated patients than the DCLHb-treated patients (p = 0.041). At the highest dose level (200 mL), statistically significant between-group differences were observed with greater increases in serum amylase, LDH, the isoenzymes LD1,2,4 and 5, and CK-MB in the DCLHb group compared to the control group; none were of clinical significance. The volume of blood administered did not differ between the groups. Overall 24- and 72-hour survival rates were similar between treatment groups, although the hospital discharge rate was slightly higher in the DCLHb-treated patients (80%) compared with the saline-treated patients (74%). CONCLUSION: Administration of 50 to 200 mL of DCLHb to patients in hemorrhagic, hypovolemic shock was not associated with evidence of end organ toxicity or significant adverse events. Further studies involving larger doses and, perhaps, earlier administration of DCLHb are warranted. 相似文献
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Chow MS Fan C Tran H Zhao H Zhou L 《The Journal of pharmacology and experimental therapeutics》2001,297(1):224-229
The purpose of the study was to test the hypothesis that diaspirin cross-linked hemoglobin (DCLHb) can produce improved resuscitation during cardiac arrest. DCLHb, a derivative of human hemoglobin, has previously been demonstrated to produce a vasopressor response that is associated with increased blood flow to vital organs. In addition, it is an oxygen carrier. These effects may be beneficial to extreme low flow states, such as that during cardiac arrest and cardiopulmonary resuscitation (CPR). Experimental cardiac arrest and CPR were carried out in 32 anesthetized immature pigs. In each animal, ventricular fibrillation was induced for 5 min, followed by 10 min of standard CPR with a pneumatic device and room air ventilation. High (15 ml/kg) and low (5 ml/kg) doses of DCLHb or equivalent volume of normal saline were infused at the beginning of CPR in a random and blind manner. Cardiac output, organ blood flow, aortic pressure, coronary perfusion pressure, blood gases, and lactate concentrations were obtained before and during CPR. Following the 10-min CPR, the animals were defibrillated and the return of spontaneous circulation (ROSC) determined. DCLHb treatment achieved 75% ROSC compared with 25% in the saline group (p < 0.05). In addition, a better (p < 0.05) myocardial O(2) delivery, venous blood O(2) content, and myocardial and cerebral perfusion pressure were observed in the DCLHb group. DCLHb treatment during cardiac arrest and CPR significantly improves ROSC. This is most likely related to its improvement in coronary perfusion and myocardial oxygen delivery. 相似文献
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Neal W. Dickert Victoria A. Mah Jill M. Baren Michelle H. Biros Prasanthi Govindarajan Arthur Pancioli Robert Silbergleit David W. Wright Rebecca D. Pentz 《Resuscitation》2013
Background
Resuscitation research requires an exception from informed consent (EFIC). Despite concerns that patients may find EFIC unacceptable, the views and experiences of patients enrolled in an EFIC study are largely unknown.Methods
The Patients’ Experience in Emergency Research (PEER) study was nested within the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) for pre-hospital treatment of status epilepticus. PEER included 61 EFIC enrollees or their surrogates from 5 sites. Interviews used a structured, interactive guide focusing on acceptance of EFIC enrollment in RAMPART and existing regulatory protections. Simple statistics were generated, and textual data were analyzed for common themes.Results
24 enrolled patients and 37 surrogates were successfully interviewed. 49/60 (82%) were glad they or their family member were included in RAMPART; 54/57 (95%) felt research on emergency seizure treatment is important. 43/59 (73%) found their inclusion under EFIC acceptable; 10 (17%) found it unacceptable, and 6 (10%) were neutral. There were no statistically significant interactions between enrollment attitudes and demographic characteristics, though there were trends toward lower acceptance among interviewees who were non-white, less educated, or had prior research experience. The most common concerns related to lack of consent prior to RAMPART enrollment. Positive responses related to perceived medical benefits, recognition of the impracticality of consent, and wanting doctors to do what needs to be done in emergencies. Many participants had difficulty understanding the trial and EFIC.Conclusions
Most subjects had positive views of enrollment, and acceptance generally correlated with results of community consultation studies. 相似文献7.
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Mueller MR 《Nursing ethics》2004,11(1):42-52
This article draws on ethnographic field data collected during an investigation of the informed consent process and AIDS clinical trials. It describes the involvement of care providers (physicians, nurse practitioners, physician assistants) during the enlistment, or recruitment, phase of the informed consent process. It shows that sometimes care providers are involved in the receipt, evaluation and distribution of information on clinical trials through their interactions with research professionals and patients. It suggests that the involvement of care providers has the potential to influence the informed consent process. Some of the ethical and practice considerations of this are discussed. 相似文献
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Mindy Goldman 《Transfusion medicine reviews》2000,14(4):378
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Chanaud CM 《Contemporary clinical trials》2008,29(4):501-506
Clinical Investigators conducting biomedical research involving human participants in the U.S. are responsible for the content of the consent document(s) and for the conduct of the informed consent conference(s) with the human participants. The content of the consent forms and consent process may be governed by two different sets of U.S. regulations and may be impacted upon by separate, generally accepted, international guidelines. It can be difficult and confusing for an Investigator to determine which set(s) of regulations or guidelines apply to which studies. This article compares the two sets of U.S. regulations and two sets of well-respected international guidelines with respect to their requirements for the content of the consent document and consent conference. A practical decision tree is proposed as a tool to assist Investigators in determining which set(s) of requirements is applicable to a particular study. 相似文献
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Baue AE 《Shock (Augusta, Ga.)》2004,21(2):189; author reply 189-189; author reply 190
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Thibaut Desmettre Emilie Dehours Charles-Marc Samama Suchin Jhundoo Frédéric Pujeau Christian Guillaudin Claudine Hecquart Pierre Clerson Jean Charles Crave Roland Jaussaud 《Critical care (London, England)》2012,16(5):R185
Introduction
Prothrombin Complex Concentrate (PCC) is a key treatment in the management of bleeding related to Vitamin K antagonists (VKA). This study aimed to evaluate prospectively PCC use in patients with VKA-related bleeding in view of the French guidelines published in 2008.Methods
All consecutive patients with VKA-related bleeding treated with a 4-factor PCC (Octaplex®) were selected in 33 French hospitals. Collected data included demographics, site and severity of bleeding, modalities of PCC administration, International Normalized Ratio (INR) values before and after PCC administration, outcomes and survival rate 15 days after infusion.Results
Of 825 patients who received PCC between August 2008 and December 2010, 646 had severe bleeding. The main haemorrhage sites were intracranial (43.7%) and abdominal (24.3%). Mean INR before PCC was 4.4 ± 1.9; INR was unavailable in 12.5% of patients. The proportions of patients who received a PCC dose according to guidelines were 15.8% in patients with initial INR 2-2.5, 41.5% in patients with INR 2.5-3, 40.8% in patients with INR 3-3.5, 26.9% in patients with INR > 3.5, and 63.5% of patients with unknown INR. Vitamin K was administered in 84.7% of patients. The infused dose of PCC did not vary with initial INR; the mean dose was 25.3 ± 9.8 IU/Kg. Rates of controlled bleeding and target INR achievement were similar, regardless of whether or not patients were receiving PCC doses as per the guidelines. No differences in INR after PCC treatment were observed, regardless of whether or not vitamin K was administered. INR was first monitored after a mean time frame of 4.5 ± 5.6 hours post PCC. The overall survival rate at 15 days after PCC infusion was 75.4% (65.1% in patients with intracranial haemorrhage). A better prognosis was observed in patients reaching the target INR.Conclusions
Severe bleeding related to VKA needs to be better managed, particularly regarding the PCC infused dose, INR monitoring and administration of vitamin K. A dose of 25 IU/kg PCC appears to be efficacious in achieving a target INR of 1.5. Further studies are required to assess whether adjusting PCC dose and/or better management of INR would improve outcomes. 相似文献16.
Nootropil, a newly synthesized drug, was given intravenously to pregnant rabbits during the second half of their pregnancies in a dose of 28o mg/kg per day. Compared with controls, it increased the resistance of their foetuses to hypoxia, to which they were subjected before delivery by caesarean section. It improved their survival and made their EEG patterns more stable. The clinical history of the treatment of one human neonate, who was given 2 g/kg per day, is described. 相似文献
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Vincent JL O'Brien J Wheeler A Wittebole X Garg R Trzaskoma BL Sundin DP 《Critical care (London, England)》2006,10(3):R74-10
Introduction
Several studies have indicated that early identification and treatment of patients with severe sepsis using standard supportive care improves outcomes. Earlier treatment with drotrecogin alfa (activated) (DrotAA) may also improve outcomes in severe sepsis. Using a recently constructed integrated severe sepsis database, our objectives in this study were to describe the influence of baseline clinical characteristics on timing of DrotAA treatment in patients with severe sepsis, to evaluate the efficacy of DrotAA with respect to timing of administration, and to examine the association between early intervention with DrotAA and patient outcomes, using adjustments for imbalances. 相似文献18.
Knoller N Levi L Shoshan I Reichenthal E Razon N Rappaport ZH Biegon A 《Critical care medicine》2002,30(3):548-554
OBJECTIVE: To establish the safety of intravenous dexanabinol in severe head injury. DESIGN: Prospective, randomized, double-blind, placebo- (vehicle) controlled, multicenter, escalating dose study of a single administration of drug (48 or 150 mg) or vehicle (1 or 3 mL). SETTING: All Israeli neurosurgical intensive care units (a total of six units). PATIENTS: Sixty-seven patients, aged 16-65 yrs, Glasgow Coma Scale score of 4-8, injured within 6 hrs of treatment. MEASUREMENTS AND MAIN RESULTS: Intracranial pressure, cerebral perfusion pressure, blood pressure, and heart rate were measured continuously in the intensive care unit. Adverse medical events were recorded and clinical outcome was assessed by the Glasgow outcome scale throughout a 6-month follow-up period. A highly significant reduction in the percentage of time with intracranial pressure >25, cerebral perfusion pressure <50, and systolic blood pressure <90 mm Hg was observed in the drug-treated group. The nature and incidence of adverse medical events were similar in the two groups. The percentage of patients achieving good neurologic outcome on the Glasgow outcome scale was 21% and 14% higher in the drug-treated group at 3 and 6 months, respectively. Statistical analysis of these differences by a logistic model using dose, entry Glasgow coma scale score, and computed tomograph as covariates yielded p values for the effect of treatment of .03 and .14 at 3 and 6 months, respectively. CONCLUSIONS: Dexanabinol was safe and well tolerated in severe head injury. The treated patients achieved significantly better intracranial pressure/cerebral perfusion pressure control without jeopardizing blood pressure. A trend toward faster and better neurologic outcome was also observed. 相似文献
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J. D. Ioannovich R. D. Hinzmann G. Deichsel G. G. Steinmann 《Intensive care medicine》1996,22(4):S468-S473
Recent advances in resuscitation therapy have increased the survival rate of patients with severe burns in the burn shock phase. Infectious complications represent the major cause of death in patients with extensive burns, however, in spite of the application of early and aggressive interventions. Extensive burn injury causes profound alterations in various essential elements of the normal host immune response and the main aim of treatment after resuscitation is to maintain or even improve host resistance. The positive anti-infective effects of interferon (IFN)-gamma observed in animal models and in clinical studies, for example in chronic granulomatous disease, provided the rationale for a study to investigate its use in patients with severe burns. A study was therefore designed to determine the efficacy and tolerance of IFN-gamma in preventing death related to infection in patients with severe burn injury who are at risk of infection. In order to avoid unnecessary risk for patients and reduce the cost, a sequential design was chosen. The primary endpoint was reviewed in a group sequential manner after every 60 patients through an independent monitoring board. The study was a randomised, double-blind, Phase III multi-centre trial, conducted at 23 European Burn Centres. An interval censored survival time approach was taken, using information collected at days 8, 15, 30, 60, and 90. The trial is still blinded, but the rationale for conducting the study and its design are discussed. 相似文献
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Georg Fuernau Janine P?ss Daniel Denks Steffen Desch Gunnar H Heine Ingo Eitel Sarah Seiler Suzanne de Waha Sebastian Ewen Andreas Link Gerhard Schuler Volker Adams Michael B?hm Holger Thiele 《Critical care (London, England)》2014,18(6)