December 13, 2002

Lifesaving lung study questioned by Feds

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Lifesaving lung study questioned by Feds

Vanderbilt University Medical Center researchers, along with clinical investigators at 19 other top U.S. and Canadian academic medical centers, have been asked to supply the federal government with records from the Fluid And Catheter Treatment Trial (FACTT), and two other trials, that examined the effect of mechanical ventilator settings on intensive care patients suffering from adult respiratory distress syndrome (ARDS).

The federal Office for Human Research Protection (OHRP) has requested these records after questions were raised earlier this year about study design methods of trials.

Results of the trials are not in question. The OHRP has requested trial records because of questions raised about the study’s design, and how participants’ consent to participate was obtained.

“We realize this is the OHRP’s job to investigate these concerns and Vanderbilt has gone out of its way to cooperate with their investigation,” said Dr. Alastair J.J. Wood, assistant vice chancellor for Research. “We stand by our findings and the great work of our researchers.”

After animal studies found lower ventilator settings may actually benefit ARDS patients, a study was requested and overseen by the National Institutes of Health.

The National Heart Lung and Blood Institute (NHLBI), a division of the National Institutes of Health, requested the first ventilator trial to address the high mortality rate of ARDS. The trial was designed, conducted and monitored by members of the ARDS Network, researchers at 40 top academic medical centers.

ARDS is a devastating – and quite often fatal – inflammatory lung condition that usually occurs in conjunction with catastrophic medical conditions, such as pneumonia, shock, sepsis and trauma. Approximately 150,000 individuals contract ARDS in the United States each year. Prior to physician practice changes, a result of the ventilator trial, as many as 50 percent of ARDS patients died.

The study, which began in 1996, was halted by the safety committee designated to oversee the trial in 1999 because results of lower ventilator settings for ARDS patients were found by investigators to significantly lower patient mortality. VUMC investigators were able to demonstrate that by lowering the tidal volume, and increasing respiration rate, patients responded much better. Mortality rates among study patients on low tidal volume were10 percent lower than those of non-participants.

“The medical community has embraced the results of this trial and we believe the results are saving lives,” said Dr. Gordon Bernard, chief of the Division of Allergy/ Pulmonary and Critical Care Medicine, and one of the architects of the trial. “Use of this tidal volume (ventilator setting) will save approximately 15,000 lives per year in the United States alone.”

After initial concerns of the trial’s design were raised by other members of the medical community, the NIH convened a blue-ribbon panel of independent experts to examine the study. The NIH panel found no problems with the FACTT trial and agreed with the accuracy of the study’s data.

A letter from Dr. Claude Lenfant, director of the National Heart Lung and Blood Institute, sent to medical centers participating in the FACTT trial, and the OHRP, states the NIH’s panel of investigators unanimously found the trial was “well designed, safe and important.”

The OHRP is an independent government agency charged with the responsibility of monitoring all U.S. human clinical trials, including those sponsored by the NIH.