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SPICE 3: Does Sedation with Dexmedetomidine Increase Risk of Death at 90 Days

Study Design Summary: Multicenter trial of 3904 ICU patients who were vented for less than 12 hours at time of randomization, split roughly 50/50 into control group which used other means of sedation such as propofol, benzodiazepines or other sedatives and intervention arm which receiving mainly dexmedetomidine as sedation, with primary outcome of all causeContinue reading “SPICE 3: Does Sedation with Dexmedetomidine Increase Risk of Death at 90 Days”

MIDAS: Does Midodrine Accelerate IV Vasopressor Liberation in the ICU

Study Design Summary: Multicenter trial comparing 132 total patients who were on predefined low dose vasopressor support for at least 24 hours, randomized to receive oral midodrine or not with primary end point being time in hours to vasopressor discontinuation from randomization. Notes: The study defined successful discontinuation of vasopressors as off pressors for 24Continue reading “MIDAS: Does Midodrine Accelerate IV Vasopressor Liberation in the ICU”

WOMAN: Does TXA Reduce Mortality in Postpartum Hemorrhage

Study Design Summary: Multicenter, placebo controlled trial of adults with postpartum hemorrhage in either vaginal or cesarian section delivery with initial primary end point as composite outcome of death and need for hysterectomy, but due to well explained reasons they analyzed death secondary to bleeding as well which seems a better endpoint. Notes: The TXAContinue reading “WOMAN: Does TXA Reduce Mortality in Postpartum Hemorrhage”

HALT-IT: Does TXA Reduce Death in GI Bleeds

Study Design Summary: Multicenter, international placebo controlled trial of roughly 12,000 patients who were given TXA, primary outcome of death due to bleeding at 5 days. Notes: They used a slightly higher maintenance dose of (3g vs the usual 1g over 8 hours) in patients who were deemed to have a significant risk of deathContinue reading “HALT-IT: Does TXA Reduce Death in GI Bleeds”

CRUSADE: Does Morphine Affect Mortality in Acute Coronary Syndrome

Study Design Summary: Multicenter observational retrospective study of NSTEMI and unstable angina patients in US split into morphine vs no morphine and morphine vs nitroglycerin groups. Notes: Morphine vs no morphine: More patients in the morphine groups had death, MI, CHF and cariogenic shock events on admission. The groups were fairly unbalanced with the morphineContinue reading “CRUSADE: Does Morphine Affect Mortality in Acute Coronary Syndrome”

CRASH 2: Does TXA Reduce All Cause Mortality in Trauma Patients

Study Design Summary: Multicenter study examining TAX vs placebo in 4 week all cause mortality in adult trauma patients of both blunt and penetrating trauma. Had some interesting secondary endpoints of need for surgery and blood transfusion units given. Notes: Fairly large study of roughly 20,000 patients, equally balanced TXA and placebo groups. The primaryContinue reading “CRASH 2: Does TXA Reduce All Cause Mortality in Trauma Patients”

CRASH 3: Does TXA Reduce Head Injury Related Deaths in TBI Patients

Study Design Summary: Multinational randomized, placebo controlled study that compared giving TXA vs placebo to patients with TBI and no extracranial bleeding, primary outcome was brain injury related death at 28 days. Notes: This study has many signs pointing towards a biased study. They have many secondary endpoints and changed their definitions of inclusion criteriaContinue reading “CRASH 3: Does TXA Reduce Head Injury Related Deaths in TBI Patients”

PRORATA: Does Procalcitonin Reduce Antibiotic Exposure and Mortality

Study Design Summary: Multicenter study of 630 patients split evenly into intervention and control groups, with suspected bacterial infections, looking at 28 and 60 day mortality (non-inferiority analysis) as well as antibiotic exposure between the two groups (superiority analysis). Notes: Patients were eligible if they were not receiving antibiotics prior to enrollment or receiving antibioticsContinue reading “PRORATA: Does Procalcitonin Reduce Antibiotic Exposure and Mortality”

HEAT: Does Fever Reduction Lead to More ICU Free Days

Study Design Summary: Multicenter study in which 700 patients were split to either get 1g IV acetaminophen or not; to be eligible patients had to have a documented temperature ≥38°C with known or suspected infection. Primary outcome was ICU free days from randomization to day 28. End points were discharge from ICU, death, cessation ofContinue reading “HEAT: Does Fever Reduction Lead to More ICU Free Days”

PROSEVA: Does Prone Positioning Improve Survival in ARDS

Study Design Summary: 466 patients with severe ARDS were split roughly 50/50 into prone versus stand care groups. Prone group spent at least 16 consecutive hours per day in the prone position. To be included patients needed to be intubated and mechanically vented for ARDS for less than 36 hours. Primary end point was 28Continue reading “PROSEVA: Does Prone Positioning Improve Survival in ARDS”

REALITY-AHF: Does Early Lasix Improve Mortality in Acute Heart Failure

Study Design Summary: Observational multicenter study of patients presenting to ED for acute heart failure. No protocol on which medications/treatment to give or timing of medications since it was observational. Primary outcome was all cause in-hospital mortality. 1,291 total patients, 481 in early treatment group, 810 in nonearly group. Early treatment was defined as lasixContinue reading “REALITY-AHF: Does Early Lasix Improve Mortality in Acute Heart Failure”