NIH Unit Halts Concentrated Saline Study
The National Heart, Lung, and Blood Institute announced yesterday it has stopped a clinical trial in which patients in shock and being transported by ambulance to a hospital received a highly concentrated form of saline solution, which is thought to compensate for blood loss more effectively than a normal saline solution. NHLBI said it halted the study because the concentrated solution showed no more survival benefit than using normal saline solution. NHLBI said a parallel study of concentrated saline for traumatic brain injury without shock continues.
The trials of concentrated saline solutions are being conducted at the Resuscitation Outcomes Consortium, a network of clinical research sites in the United States and Canada. "Survival from traumatic injury is a critical public health issue, and the large clinical trials under way in this effort are needed to improve the treatment of patients. Of course, it is always disappointing when new therapies, such as concentrated saline for shock, fail to offer added benefit to patients. However, we look forward to results from the other ongoing studies that are part of this important research consortium," said Dr. Elizabeth G. Nabel, M.D., director of NHLBI, which is the lead federal sponsor of the research.
NHLBI suspended enrollment into the concentrated saline shock study on Aug. 25, 2008, because of concerns raised by ROC's Data and Safety Monitoring Board, which is an independent group that was monitoring the study. The board saw no difference among the treatment groups in 28-day mortality; more of the patients receiving concentrated saline died before reaching the hospital or in the emergency department, while more of the patients receiving normal saline died during the remainder of the 28-day follow-up period, according to NHLBI. The board asked for additional analysis of in-hospital data following saline administration in the field from 545 patients in the largest enrolling hospital from each site. The results, presented to the board Feb. 25, 2009, "confirmed the previous findings that deaths occurred earlier in patients who received [concentrated] saline and that there was no significant difference in cumulative mortality between the [concentrated] and normal saline groups at 28 days. However, the new analysis did not fully explain the mortality findings. The investigators are completing analyses of these results and will submit them for publication in a peer-reviewed scientific journal," the agency said.
A trial of brain-injured patients continues to investigate whether the concentrated saline solutions improve survival and brain function six months after traumatic injury. Concentrated saline is known to be very effective at reducing brain swelling and improving blood flow to the brain after injury, said Dr. Eileen Bulger of the University of Washington, Seattle, and Dr. David Hoyt of the University of California, Irvine, co-principal investigators of these studies.