Out‐of‐hospital Administration of Mannitol to Head‐injured Patients Does Not Change Systolic Blood Pressure

Abstract

Objective: To determine the effect of out-of-hospital mannitol administration on systolic blood pressure (BP) in the head-injured multiple-trauma patient.Methods: This was a prospective, randomized, double-blind, placebo-controlled clinical trial involving a university-based helicopter air medical service and level-1 trauma center hospital. Endotracheally intubated head-trauma victims with Glasgow Coma Scale (GCS) scores c 12 were enrolled from November 22, 1991, to November 20, 1992, if evaluated by the participating aeromedical transport team within 6 hours of injury. Patients were excluded if they were e l 8 years old, had already received mannitol or another diuretic, were potentially pregnant, or were receiving CPR. All patients were intubated prior to study drug (mannitol [l g/ kg] or normal saline) use. Pulse and BP yere measured every 15 minutes for 2 hours following study drug administration.Results: A total of 44 patients were enrolled. After exclusion of 3 patients who did not meet all inclusion criteria, there were 20 patients in the mannitol group and 21 patients in the placebo group. The groups were similar at baseline in age, pulse, systolic BP (baseline mannitol: 124 t 47 mm Hg; placebo: 128 2 32 mm Hg), GCS score, and Injury Severity Scale score. Systolic BP did not change significantly throughout the observation period in either group. This study had 83% power to detect a mean systolic BP drop to <90 mm Hg. Conclusion:Out-of-hospital administration of mannitol did not significantly change systolic BP in this group of head-injured multigle-trauma patients.Key words: head injury; brain injury; mannitol; emergency medical services; patient transport; hemodynamics-blood pressure. I The most common cause of death in the UnitedStates among persons aged 1-44 years is injury. ~p -proximately 50% of all trauma deaths are due to head injury,' and there are about 19 head-injury deaths annually per ~00,000 U.S. residents.2 At the present time, the optimal treatment for severe head injury is unknown.One of the mechanisms for the high morbidity and mortality associated with head injury is a rise in intra- Center;

Feasibility of Acute Clinical Trials During Aerial Interhospital Transfer

“…Unlike trauma field trials, where informed consent may be waived, 9 ethical and legal regulations are likely to require such consent for a population of stroke patients already admitted to local hospitals. Many of the stroke and MI patients in this study appeared awake and sufficiently coherent to be able to legally sign a consent form.…”

“…Because patients in rural America with stroke or myocardial infarction (MI) often are transferred to a tertiary care center by helicopter for further care, [5][6][7][8] one option is to have the patient enrolled at the local ED by those tertiary care center-based aerial medical personnel (potential coinvestigators) when they arrive at the site. There are reports of clinical trials in aerially evacuated trauma patients, 9 but to our knowledge, such an approach has not been used for either stroke or MI. If clinical research were feasible during that early aerial interhospital transport, patients might be enrolled at a critical earlier stage.…”

Randomized controlled trials affecting polytrauma care

“…Sayre et al randomized, in a double-blinded fashion, 44 head-injured patients to either prehospital 20% mannitol (5 ml/kg) or a placebo of 5 ml/kg normal saline [34]. There was no significant difference in mortality or change in systolic blood pressure between the groups.…”

How effective are some common treatments for traumatic brain injury?

“…9 In 1998 the Cochrane Injuries Group highlighted the absence of reliable evidence for the effectiveness of these four treatments 10 when searches identified only three small trials of barbiturates, 11 12 13 none of cerebrospinal fluid drainage, one small trial of hyperventilation, 14 and one small trial of the use of mannitol. 15 Our latest searches, to January 2008, indicate that there remains a lack of adequately powered randomised controlled trials of these interventions, with no additional trials found. The uncertainty is evident in the meta-analyses presented in the figure⇓.…”