A concentrated salt solution will be tested on people too injured to give their consent to the experiment
By Andy Dworkin
The Oregonian (Portland, Oregon)
Copyright 2007 The Oregonian
All Rights Reserved
Local medics are ready to start testing a new method of revival on trauma victims who are too badly hurt to give their consent.
Last year, Portland was scheduled to join several other U.S. and Canadian cities in testing hypertonic saline, a concentrated salt solution meant to replace lost blood. But the study was suspended while doctors worked out how to test and track patients who got the solution after they were admitted to a hospital.
Those procedures have been settled, and ambulance crews in Clackamas and Washington counties were ready to enroll trauma victims in the study as of Tuesday, said Liana Haywood, a spokeswoman for Oregon Health & Science University, which is leading the local portion of the trial. Clark County will be ready to enroll test subjects Monday, with Multnomah County joining Jan. 15.
The saline study is unusual because the people subjected to the test can’t agree to the experiment beforehand. That advanced permission, called “informed consent,” is central to most medical experiments. But the saline solution is being used on trauma victims too badly hurt to give normal consent. So the trial is being run under a federal rule that allows lifesaving treatments to be tested on patients who can’t consent.
Most people who receive the solution will probably be car-crash victims. People who have lost lots of blood or suffered severe brain injuries will either get normal saline solution or one of two more concentrated versions given at the trauma scene. Those patients will get blood, if needed, once they get to a hospital and be told about the study once they are conscious and thinking clearly. In Portland, doctors expect to enroll 50 to 100 people a year for blood loss and three to four times that number for head trauma. Women who are obviously pregnant, children 14 and younger, and people under arrest are excluded from the trial.
Doctors hope the salty solution will help some of the 100,000-plus U.S. residents killed by trauma each year. Now, paramedics give those people a standard saline solution to replace lost blood. (Ambulances don’t carry blood because it is too perishable.) Some researchers think a solution containing more salt will limit brain swelling or a life-threatening inflammation that sometimes destroys organs days after a trauma.
Earlier and smaller studies of concentrated saline have not resulted in bad side effects or proved the saltier liquid is better. Doctors do know that the concentrated solution raises the body’s sodium level. The new study procedures say hospitals must test a patient’s sodium level three times in the day after they are enrolled in the trial and requires someone on the hospital staff to be knowledgeable about the study.
While no one involved will give normal consent, doctors made several presentations about the study around Portland last year to gauge the community’s feedback, as required by federal law. Hospital and county administrators have also approved the test.
People who want to avoid the trial can get a bracelet to wear that signals they do not want to take part by e-mailing their name and mailing address to or calling 503-494-7015. About 350 people have received bracelets so far, Haywood said.