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A structured approach to neurologic prognostication in clinical cardiac arrest trials.

ABSTRACT: Brain injury is the dominant cause of death for cardiac arrest patients who are admitted to an intensive care unit, and the majority of patients die after withdrawal of life sustaining therapy (WLST) based on a presumed poor neurologic outcome. Mild induced hypothermia was found to decrease the reliability of several methods for neurological prognostication. Algorithms for prediction of outcome, that were developed before the introduction of mild hypothermia after cardiac arrest, may have affected the results of studies with hypothermia-treated patients. In previous trials on neuroprotection after cardiac arrest, including the pivotal hypothermia trials, the methods for prognostication and the reasons for WLST were not reported and may have had an effect on outcome. In the Target Temperature Management trial, in which 950 cardiac arrest patients have been randomized to treatment at 33°C or 36°C, neuroprognostication and WLST-decisions are strictly protocolized and registered. Prognostication is delayed to at least 72 hours after the end of the intervention period, thus a minimum of 4.5 days after the cardiac arrest, and is based on multiple parameters to account for the possible effects of hypothermia.

SUBMITTER: Cronberg T

PROVIDER: S-EPMC3691620 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

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A structured approach to neurologic prognostication in clinical cardiac arrest trials.

Cronberg Tobias T Horn Janneke J Kuiper Michael A MA Friberg Hans H Nielsen Niklas N

Scandinavian journal of trauma, resuscitation and emergency medicine 20130610

Brain injury is the dominant cause of death for cardiac arrest patients who are admitted to an intensive care unit, and the majority of patients die after withdrawal of life sustaining therapy (WLST) based on a presumed poor neurologic outcome. Mild induced hypothermia was found to decrease the reliability of several methods for neurological prognostication. Algorithms for prediction of outcome, that were developed before the introduction of mild hypothermia after cardiac arrest, may have affect ...[more]

PMID: 23759121

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Project description:ObjectiveTo implement a standardized approach to characterize neurologic outcomes among 12-month survivors in the Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trials.MethodsTwo multicenter trials enrolled children age 48 hours to 18 years who remained comatose after cardiac arrest (CA) occurring out-of-hospital (THAPCA-OH, NCT00878644) or in-hospital (THAPCA-IH, NCT00880087); patients were randomized to therapeutic hypothermia or therapeutic normothermia. The primary outcome, survival with favorable 12-month neurobehavioral outcome (Vineland Adaptive Behavior Scales [VABS-II]), did not differ between treatment groups in either trial. Neurologists examined 181 12-month survivors, described findings using the novel semi-quantitative Pediatric Resuscitation after Cardiac Arrest (PRCA) form, and rated findings in 6 domains; scores ranged from 0 (no deficits) to 21 (maximal deficits). PRCA scores were compared with 12-month VABS-II scores and cognitive scores.ResultsNeurologic outcome PRCA scores were classified as no/minimal impairment, PRCA 0-3, 81/179 (45%); mild impairment, PRCA 4-7, 24/179 (13%); moderate impairment, PRCA 8-11, 15/179 (8%); severe impairment, PRCA 12-16, 20/179 (11%); profound impairment, PRCA 17-21, 39/179 (21%) (2/181 incomplete). VABS-II scores correlated strongly with PRCA category (r = -0.88, p < 0.0001, Pearson correlation coefficient) and cognitive scores (r = -0.72, p < 0.0001). Factors associated with poor outcomes included out-of-hospital CA, seizure recognition in the early postarrest period, and poor neurologic status at hospital discharge.ConclusionThe PRCA provides a robust method for depicting neurologic outcomes after acute encephalopathy caused by CA in children. It provides a global semiquantitative rating of neurologic impairment and domain-specific impairment. The strong correlation with well-established neurobehavioral outcome measures supports its validity over a broad age range and wide spectrum of outcomes.

Project description:ImportanceTherapeutic hypothermia may increase survival with good neurologic outcome after cardiac arrest. Trans-nasal evaporative cooling is a method used to induce cooling, primarily of the brain, during cardiopulmonary resuscitation (ie, intra-arrest).ObjectiveTo determine whether prehospital trans-nasal evaporative intra-arrest cooling improves survival with good neurologic outcome compared with cooling initiated after hospital arrival.Design, setting, and participantsThe PRINCESS trial was an investigator-initiated, randomized, clinical, international multicenter study with blinded assessment of the outcome, performed by emergency medical services in 7 European countries from July 2010 to January 2018, with final follow-up on April 29, 2018. In total, 677 patients with bystander-witnessed out-of-hospital cardiac arrest were enrolled.InterventionsPatients were randomly assigned to receive trans-nasal evaporative intra-arrest cooling (n = 343) or standard care (n = 334). Patients admitted to the hospital in both groups received systemic therapeutic hypothermia at 32°C to 34°C for 24 hours.Main outcomes and measuresThe primary outcome was survival with good neurologic outcome, defined as Cerebral Performance Category (CPC) 1-2, at 90 days. Secondary outcomes were survival at 90 days and time to reach core body temperature less than 34°C.ResultsAmong the 677 randomized patients (median age, 65 years; 172 [25%] women), 671 completed the trial. Median time to core temperature less than 34°C was 105 minutes in the intervention group vs 182 minutes in the control group (P < .001). The number of patients with CPC 1-2 at 90 days was 56 of 337 (16.6%) in the intervention cooling group vs 45 of 334 (13.5%) in the control group (difference, 3.1% [95% CI, -2.3% to 8.5%]; relative risk [RR], 1.23 [95% CI, 0.86-1.72]; P = .25). In the intervention group, 60 of 337 patients (17.8%) were alive at 90 days vs 52 of 334 (15.6%) in the control group (difference, 2.2% [95% CI, -3.4% to 7.9%]; RR, 1.14 [95% CI, 0.81-1.57]; P = .44). Minor nosebleed was the most common device-related adverse event, reported in 45 of 337 patients (13%) in the intervention group. The adverse event rate within 7 days was similar between groups.Conclusions and relevanceAmong patients with out-of-hospital cardiac arrest, trans-nasal evaporative intra-arrest cooling compared with usual care did not result in a statistically significant improvement in survival with good neurologic outcome at 90 days.Trial registrationClinicalTrials.gov Identifier: NCT01400373.

Project description:ObjectivesAbsence of somatosensory evoked potentials is considered a nearly perfect predictor of poor outcome after cardiac arrest. However, reports of good outcomes despite absent somatosensory evoked potentials and high rates of withdrawal of life-sustaining therapies have raised concerns that estimates of the prognostic value of absent somatosensory evoked potentials may be biased by self-fulfilling prophecies. We aimed to develop an unbiased estimate of the false positive rate of absent somatosensory evoked potentials as a predictor of poor outcome after cardiac arrest.Data sourcesPubMed.Study selectionWe selected 35 studies in cardiac arrest prognostication that reported somatosensory evoked potentials.Data extractionIn each study, we identified rates of withdrawal of life-sustaining therapies and good outcomes despite absent somatosensory evoked potentials. We appraised studies for potential biases using the Quality in Prognosis Studies tool. Using these data, we developed a statistical model to estimate the false positive rate of absent somatosensory evoked potentials adjusted for withdrawal of life-sustaining therapies rate.Data synthesisTwo-thousand one-hundred thirty-three subjects underwent somatosensory evoked potential testing. Five-hundred ninety-four had absent somatosensory evoked potentials; of these, 14 had good functional outcomes. The rate of withdrawal of life-sustaining therapies for subjects with absent somatosensory evoked potential could be estimated in 14 of the 35 studies (mean 80%, median 100%). The false positive rate for absent somatosensory evoked potential in predicting poor neurologic outcome, adjusted for a withdrawal of life-sustaining therapies rate of 80%, is 7.7% (95% CI, 4-13%).ConclusionsAbsent cortical somatosensory evoked potentials do not infallibly predict poor outcome in patients with coma following cardiac arrest. The chances of survival in subjects with absent somatosensory evoked potentials, though low, may be substantially higher than generally believed.

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A structured approach to neurologic prognostication in clinical cardiac arrest trials.

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A structured approach to neurologic prognostication in clinical cardiac arrest trials.

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