Mark Sebastian

Randomized, placebo-controlled trial of lisofylline for early treatment of acute lung injury and acute respiratory distress syndrome

Objective To determine whether the administration of lisofylline (1-[5R-hydroxyhexyl]-3,7-dimethylxanthine) would decrease mortality in patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). Design A prospective, randomized, double-blind, placebo-controlled, multicenter study. Setting Intensive care units at 21 hospitals at the ten centers constituting the ARDS Clinical Trials Network. Patients A total of 235 patients who met eligibility criteria were enrolled in the study (116 into the lisofylline group, 119 into the placebo group). Interventions Patients were randomized to receive either lisofylline or placebo. The dose of lisofylline was 3 mg/kg with a maximum dose of 300 mg intravenously every 6 hrs. The intravenous solution of study drug was administered over 10 mins every 6 hrs. Dosing was continued for 20 days or until the patient achieved 48 hrs of unassisted breathing. Measurements and Main Results The trial was stopped by the Data Safety Monitoring Board for futility at the first scheduled interim analysis. The patient groups had similar characteristics at enrollment. No significant safety concerns were associated with lisofylline therapy. There was no significant difference between groups in the number of patients who had died at 28 days (31.9% lisofylline vs. 24.7% placebo, p = .215). There was no significant difference between the lisofylline and placebo groups in terms of resolution of organ failures, ventilator-free days, infection-related deaths, or development of serious infection during the 28-day study period. The median number of organ failure–free days for the five nonpulmonary organ failures examined (cardiovascular, central nervous system, coagulation, hepatic, and renal) was not different between the lisofylline and placebo groups. Although lisofylline has been reported to decrease circulating free fatty acid levels, we did not find any such treatment effect compared with placebo. Conclusions In this study, there was no evidence that lisofylline had beneficial effects in the treatment of established ALI/ARDS.

Massive Transfusion Exceeding 50 Units of Blood Products in Trauma Patients

BACKGROUND Massive transfusion of blood products in trauma patients can acutely deplete the blood bank. It was hypothesized that, despite a large allocation of resources to trauma patients receiving more than 50 units of blood products in the first 24 hours, outcome data would support the continued practice of massive transfusion. METHODS A retrospective review of charts and registry data of trauma patients who received over 50 units of blood products in the first day was conducted for a 5-year period at a Level I trauma center. Patients were stratified into groups on the basis of the number of transfusions received. Results are expressed as mean +/- SD. Univariate analysis and multivariate logistic regression were used to identify those risk factors determined in the first 24 hours after admission that were predictive of mortality. Physiologic differences between survivors and nonsurvivors were also examined. RESULTS Of 7,734 trauma patients admitted between July 1, 1995, and June 30, 2000, 44 (0.6%) received > 50 units of blood products in the first day. Overall mortality in these patients was 57%. There was no significant difference (p = 0.565, chi2) in mortality rate between patients who received > 75 units of blood products in the first day versus those who received 51 to 75 units. Multiple logistic regression analysis identified only one independent risk factor, base deficit > 12 mmol/L, associated with mortality. Base deficit > 12 mmol/L increases the risk of death by 5.5 times (p = 0.013; 95% confidence interval, 1.44-20.95). Neither the total blood product transfusion requirement in the first day nor the packed red blood cell transfusion amount in the first day were significant independent risk factors. Causes of the 25 deaths in this series included exsanguination in the operating room (n = 1) or in the surgical intensive care unit (n = 12), multiple organ failure/sepsis (n = 3), head injury (n = 3), respiratory failure (n = 2), cerebrovascular accident (n = 1), and other (n = 3). Of the survivors, 63% were discharged to home, 21% to rehabilitation, 11% to nursing home, and 5% to another acute care facility. Of the nonsurvivors, the mean Injury Severity Score was 43, 88% had a base deficit > 12 mmol/L, 68% had a Glasgow Coma Scale score < 8, and 64% had a Sequential Organ Failure Assessment score > 10. CONCLUSION The 43% survival rate in trauma patients receiving > 50 units of blood products warrants continued aggressive transfusion therapy in the first 24 hours after admission.

Blunt vascular injuries of the head and neck: is heparinization necessary?

BACKGROUND Blunt vascular injuries to the head and neck (BHVI) represent some of the most devastating and morbid injuries seen by a trauma surgeon. This series reviewed the experience of a single institution to determine if diagnostic and therapeutic guidelines can be established for these uncommon injuries. In particular, the utility of anticoagulation in the treatment of these injuries is examined. METHODS The institutional trauma registry of a single state-designated Level I trauma center was examined for patients with BHVI. Patients were identified and their charts reviewed individually with regard to multiple data points including the type of injury, its presentation, the treatment of the injury, and the functional outcome of the patient. RESULTS Twenty-nine BHVI in 23 patients were reviewed from 1989 to 1997. No mortalities were noted. Among the injuries noted were 14 internal carotid artery dissections and 8 carotid artery tears. Thirteen patients had accompanying closed head injuries. Ten patients were diagnosed after an abnormal neurologic examination, and eight others were diagnosed after having carotid canal fractures. Heparin was started within 48 hours of injury in 4 patients (17%) and was used in a total of 12 patients (52%). No patient worsened neurologically after diagnosis independent of the use of heparin. Thirteen patients (57%) had no or minimal deficits upon discharge. CONCLUSION BHVI represent a serious cause of morbidity in the patient with multiple injuries. Patients with closed head injuries and carotid canal fractures appear most at risk. A multicenter, randomized trial involving antiplatelet therapy, full systemic anticoagulation, or observation with a long-term functional assessment is indicated to determine the optimal management of these injuries.

Debriefing in the intensive care unit: a feedback tool to facilitate bedside teaching.

Objective:To develop an assessment tool for bedside teaching in the intensive care unit (ICU) that provides feedback to residents about their performance compared with clinical best practices. Method:We reviewed the literature on the assessment of resident clinical performance in critical care medicine and summarized the strengths and weaknesses of these assessments. Using debriefing after simulation as a model, we created five checklists for different situations encountered in the ICU—areas that encompass different Accreditation Council for Graduate Medical Education core competencies. Checklists were designed to incorporate clinical best practices as defined by the literature and institutional practices as defined by the critical care professionals working in our ICUs. Checklists were used at the beginning of the rotation to explicitly define our expectations to residents and were used during the rotation after a clinical encounter by the resident and supervising physician to review a resident’s performance and to provide feedback to the resident on the accuracy of the resident’s self-assessment of his or her performance. Results:Five “best practice” checklists were developed: central catheter placement, consultation, family discussions, resuscitation of hemorrhagic shock, and resuscitation of septic shock. On average, residents completed 2.6 checklists per rotation. Use of the cards was fairly evenly distributed, with the exception of resuscitation of hemorrhagic shock, which occurs less frequently than the other encounters in the medical ICU. Those who used more debriefing cards had higher fellow and faculty evaluations. Residents felt that debriefing cards were a useful learning tool in the ICU. Conclusions:Debriefing sessions using checklists can be successfully implemented in ICU rotations. Checklists can be used to assess both resident performance and consistency of practice with respect to published standards of care in critical care medicine.

Cost Containment in Vascular Surgery

In the last decade, the delivery of health care and the role of the physician have undergone radical change. With the ad vent of managed care and the tightening of restrictions by Medicare and insurance companies, physicians have been required to review, re-engineer, and revitalize their role. Increasing financial pressures at the hospital level have caused administrators to cut costs at all levels. It is imper ative that physicians take an active role in cost containment so that the quality of care is not sacrificed. Cost containment in vascular surgery is an urgent priority in health care. Copyright