ROC Hypertonic Saline Dextran Study

[Blahblahologist]

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I've been doing research for the past several months about whether or not there's a benefit to doing pre-hospital resuscitation with hypertonic saline and dextran has benefits for hypovolemic shock patients. I was really excited when I read about the proposal by the Resuscitation Outcomes Consortium to enroll a population of about 5000 in the study-- finally (I thought naively) a straight answer with a hefty sample size.

Only, they've suspended the study due to "concerns about patient safety, relative to the likelihood of benefits." I'm wondering if anyone knows what happened.

Since the likelihood of a patient having a negative reaction to HTS or Dextran is almost zero, so I'm curious as to what safety issues they encountered. Or is it more likely the simply couldn't show any long-term benefit for HTS+D as a resuscitation fluid (which has been a problem for past studies) and called it quits early?

 

[leviathan]

I've been doing research for the past several months about whether or not there's a benefit to doing pre-hospital resuscitation with hypertonic saline and dextran has benefits for hypovolemic shock patients. I was really excited when I read about the proposal by the Resuscitation Outcomes Consortium to enroll a population of about 5000 in the study-- finally (I thought naively) a straight answer with a hefty sample size.

Only, they've suspended the study due to "concerns about patient safety, relative to the likelihood of benefits." I'm wondering if anyone knows what happened.

Since the likelihood of a patient having a negative reaction to HTS or Dextran is almost zero, so I'm curious as to what safety issues they encountered. Or is it more likely the simply couldn't show any long-term benefit for HTS+D as a resuscitation fluid (which has been a problem for past studies) and called it quits early?

We're part of that study here as well, and it was also discontinued for us back in September. I think it just didn't show any efficacy, and since dextran does have sensitivity risks in a small population of people, there was no point in continuing. That's just my guess. I also wonder how other services were studying were introducing this fluid, as that may have made a difference. I think time to arrival at a trauma hospital is still the #1 most important factor in survival, so if people are still starting IVs on scene for traumas, then it doesn't matter what fluids you are infusing and it won't make a difference. Our guidelines here are to poke the patient once already en route, but for some reason that doesn't get through to many paramedics here who still insist on doing an IV on scene first.