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Sunday, July 29, 2012 - Page updated at 04:30 p.m.

Double-blind study tests heart-rhythm drugs

The Oregonian

PORTLAND — In the next three years, about 400 people on the brink of death will be part of a study for which they did not volunteer.

In Clackamas and Washington counties in Oregon, and Clark County in Washington state, paramedics responding to unconscious people in cardiac arrest will administer CPR, then shock with a defibrillator. That's standard procedure, but if that doesn't work, a paramedic will pull open a mystery packet of unlabeled syringes for injection.

Inside will be either one of two heart-rhythm medications, or a simple saline solution — saltwater.

Neither paramedics nor doctors will be told what the syringes contained. Researchers later will use bar codes on the syringe to see if survival rates differ between them.

If that sounds ethically dubious and like a roll of the dice for the patient, then Dr. Mohamud Daya of Oregon Health & Science University (OHSU) would like to welcome you to emergency cardiac-arrest care today.

"That's the sad part about EMS," he said. "We're to some extent doing things without really any solid evidence to know what we're doing."

The study is the latest in a series of its kind, and it is expect to include 3,000 cardiac arrests around the country. The goal: determine the best way to revive a heart that stops pumping blood, quivering randomly instead — called ventricular fibrillation. The two heart-rhythm drugs, Amiodarone and Lidocaine, have been used for years.

Sudden cardiac arrest, often associated with ventricular fibrillation, strikes more than 300,000 people a year in the U.S.

Normally, research rules require study subjects to consent in advance. But years ago, new federal regulations allowed studies like this one as long as measures are taken to alert the public, including public hearings.

For now, scientists don't know which medication is more effective — or whether the drugs are effective at all, according to Daya.

A 1999 study found a placebo was as effective as Amiodarone for saving the lives of patients in ventricular fibrillation. Meanwhile, patients on Lidocaine were substantially less likely to make it to the hospital alive than if they were on Amiodarone, a 2002 study found.

Still, emergency responders continue to choose between the two drugs based on opinion, not science: "We're experimenting anyway, we're just not doing it under formal regulatory rules," Daya said.

The study is one of a series coordinated by OHSU, one of 10 research centers participating in a national effort to improve emergency medical care. Emergency crews began using the unlabeled syringes last month in Clark County. The study rolled out this month in Clackamas Fire and Lake Oswego Fire. Next month it spreads to Hillsboro Fire, Tualatin Valley Fire and Rescue, and AMR Clackamas County.

Daya traces his passion for research to when he first helped resuscitate a patient on an emergency call in 1985, and he felt a rush of adrenaline. "It's an incredibly powerful feeling," he said. "That's what gets you hooked into it. That's probably the time when you ask yourself, how can you bring more people back?"

He became medical director for the Portland Fire Bureau, then an ambulance company. Now he's medical director for Tualatin Valley Fire and Rescue as well as Forest Grove Fire and Rescue, advising them as he works as an emergency-room physician at OHSU.

Over time, he's watched as EMS practices and cardiac care have changed repeatedly. It used to be heart attacks would be treated with bed rest, but over time, better technology has been used to revive people and unclog arteries.

Daya thinks more can be done. Using CPR, defibrillators and medications, he said, "we try 100 patients, and we get 10 of them back if we're lucky. Why can't we get back 20, 30 or 40? "

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