Researchers say treatments have performed well

Emergency treatments being tested in King County on cardiac-arrest and trauma patients without their consent have track records of safety in previous smaller studies, researchers say.

However, doctors at the University of Washington conducting the studies don't know if the experimental treatments will work better or worse than existing treatments.

The studies are controversial because they bypass traditional requirements for "informed consent." Some ethicists say having an individual patient's best interest at heart is very different from following a research protocol.

Some point to earlier studies of synthetic blood substitutes, which looked promising initially but may have ultimately cost patients their lives. "That's the whole point of research — you don't know," said George Annas, a medical-ethics expert at Boston University.

The King County study on trauma patients will test a stronger saline solution than the one now used to restore blood pressure and limit brain swelling. The "hypertonic" solution would be used with or without an added sugar solution called dextran.

The concentrated solution with dextran is now used in 14 European countries, according to Dr. Eileen Bulger, a trauma surgeon at Harborview Medical Center who heads the study. The solution had no reported adverse effects in eight small trials, and reports from Europe show no major safety concerns.

"It has a strong track record," she said.

However, the solution does have "hypothetical risks," Bulger noted, including impaired blood coagulation, allergic reactions and seizures.

A 2005 article in Shock, a medical journal, noted possible "severe allergic reactions" to dextran but concluded that risk was minimal.

In a small study of about 200 local patients, the supersaline solution with dextran didn't appear to affect the overall chance of death or later lung disease. But it did appear to help severely injured patients who required lots of blood.

An Australian study published in 2004 found that 229 trauma patients with brain injuries had similar survival and long-term neurological function whether treated with hypertonic or standard saline.

Trauma and cardiac-arrest patients already have high rates of death.

Bulger said trauma is the top killer of those under 45 years old.

Dr. Peter Kudenchuk, a UW cardiologist who is involved with both studies, said only about 5 percent to 6 percent of cardiac-arrest victims nationwide survive.

A local study starting next month will test whether a longer period of CPR before electrical defibrillation will improve chances of survival.

Kudenchuk said both short and long periods of CPR are now used in different places because it's unclear which is best.

"We are trying to combat a major public-health problem that claims 180,000 Americans each year [500 per day] for which — without the conduct of such trials — there is little hope of needed advances to improve the outlook for its victims," Kudenchuk said.

Previous small studies of longer periods of CPR before defibrillation have been mixed. One study in Australia found no difference. A 1999 Seattle study found improvement in patients who had waited more than four minutes for an ambulance.

That study also will test a device researchers hope will help oxygenate blood during CPR. A 2005 study of 230 cardiac-arrest patients in Wisconsin found the device doubled the short-term survival rate.

The research is funded by the National Institutes of Health, the Department of Defense and other agencies. Researchers have noted military interest in the experimental treatments, particularly in concentrated saline for trauma victims.

Carol M. Ostrom: 206-464-2249 or costrom@seattletimes.com