2016 Top Papers in Critical Care

Transcription

1 2016 Top Papers in Critical Care Briana Witherspoon DNP, APRN, ACNP-BC Assistant Director of Advanced Practice, Neuroscience Assistant in Division of Critical Care, Department of Anesthesiology Neuroscience Critical Care Nurse Practitioner

2 Objectives Examine four studies that have been published in a highly reputable, peer reviewed journal within the last months Identify and discuss the background, objective, methods, results, and limitations of each study Confirm current practice or encourage an evidence based change to current practice

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4 Background Brain injury is the primary cause of death in patients treated in an ICU after out-of-hospital cardiac arrest Severe neurologic impairment in long-term survivors is rare, with most having little to no disability

5 Objective To compare the effects of two target temperature regimens on long term cognitive function and quality of life after cardiac arrest

6 Trial design Methods Parallel group of randomized clinical trials performed in 36 ICUs in Europe and Australia Patients Inclusion Criteria Adult GCS 8 Out- of hospital CA with ROSC Exclusion Criteria 240 minutes ROSC Unwitnessed CA with asystole Suspected/known CVA Temp < 30 o C

7 Methods Randomization and Masking Eligible patients were randomly assigned 1:1 to TTM at either 33 o C or 36 o C Clinicians were not masked to the interventions, but were instructed not to discuss allocation temperature with the patients relatives

8 Methods Clinical Outcome Assessment 6 months after CA patients and their families were asked to participate in a follow up assessment via phone or in-person Outcomes were assessed from 4 perspectives: clinician-reported measures performance measures observer-reported measures patient reported measures

9 Methods Clinician reported measures Performancemeasures Observer-reported measures Patient-reported measures Cerebral Performance Categories (CPC) scale Modified Rankin Scale (mrs) Mini-Mental State Examination (MMSE) MMSE Adult Lifestyles and Function Interview (ALFI) for phone interviews Informant Questionnaire of Cognitive Decline in the Elderly (IQCODE) Two-Simple Questions Medical Outcomes Study Short Form Health Survey (SF-36v2) *MMSE and the IQCODE have not been validated in this specific population

10 Results Patients were enrolled from November 2011 January 2013 Total sample size of 939 patients 473 assigned to 33 o C and 466 assigned to 36 o C At follow up 245 were alive in the 33 o C group and 246 in the 36 o C group Median time from CA to follow up was 186 days

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13 Limitations More patients in the 33 o C group have <12 years of education The optimum timing of patient assessment post CA remains to be determined Risk of bias if informants noted allocated temperature at the bedside during the intervention

14 Conclusion Both quality of life and cognitive function was similar in patients with cardiac arrest receiving targeted temperature management at 33 o C or 36 o C

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16 Background The administration of IV fluids to increase intravascular volume or maintain hydration is a common intervention in the ICU 0.9% saline (NS) is the most commonly used resuscitation fluid Does the high chloride content of saline contribute to the development of AKI?

17 Objective To determine the effect of a buffered crystalloid compared with saline on renal complications in patients admitted to the ICU

18 Study Design prospective investigator initiated multicenter blinded cluster-randomized double crossover Methods Conducted in 4 tertiary ICUs in New Zealand A predefined statistical analysis plan was reported and published prior to recruitment

19 Patients Methods All patients receiving crystalloid fluid therapy as clinically indicated were eligible Exclusions: patients on RRT or expected to require RRT within 6 hours, donor patients, palliative care patients, and patients previously enrolled in the study

20 Methods Study Randomization and Treatment ICUs were assigned to use blinded study fluids for alternating treatment blocks of 7 weeks Investigators and clinicians were blind to the study fluid allocation for the duration of the study The treating clinician determined the rate and frequency of fluid administration. FLUID A FLUID B

21 Primary outcome the proportion of patients with AKI, defined as a degree of renal dysfunction or injury or greater based on creatinine Methods Secondary outcomes Difference in creatinine pre/post ICU Use of RRT in the ICU and the requirements for RRT after discharge The proportion of patients requiring mechanical ventilation The proportion of patients requiring ICU readmission during their hospital stay ICU and hospital LOS ICU and hospital mortality

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23 Results 9.6% vs 9.2 % of patients developed AKI within 90 days No significant difference in: the probability of requiring RRT service utilization use or duration of mechanical ventilation rates of death in the ICU or hospital cause specific mortality at 90 days

24 Limitations No sample size calculations > 90% of patients were exposed to IV fluids before enrollment Heterogeneous population of patients who were critically ill with low overall mortality

25 Conclusion This study found that there was no significant difference in rate of AKI in critically ill patients who received normal saline vs. plasmalyte

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27 Background Limited data available on the target blood pressure range when treating acute hypertensive response in patients with ICH INTERACT2 trial found no significant difference in death or disability among patients in the intensive BP reduction arm vs. the guideline recommended treatment arm

28 Objective To determine the efficacy of rapidly lowering the SBP level in patients in an earlier time window after symptom onset than that evaluated in previous trials

29 Trial Design randomized multicenter open-label trial Methods evaluating the efficacy of intensive versus standard antihypertensive treatment that was initiated within 4.5 hours after symptom onset and continued for the next 24 hours at least one SBP reading of 180mm Hg between symptom onset and treatment was required

30 Methods Treatment for SBP 180 could be initiated before randomization to lower than 180mm Hg as per guidelines, patients were not eligible if SBP 140 mmhg prior to randomization Trial initially recruited patients within 3 hours of symptom onset, but window was extended to 4.5 hours based on new data

31 Methods Inclusion Criteria 18 years of age or older GCS score 5 Initial CTH with IPH < 60 cm 3 Treatment initiated within 4.5 hours of symptom onset Randomization performed centrally through the trial website using a minimization algorithm combined with the biased-coin method Trial Oversight an independent oversight committee evaluated adherence to protocols

32 Trial Interventions Methods Goal of treatment was to reduce and maintain the hourly minimum SBP in the mmhg range in the standard group and in the mmHg range in the intensive treatment group throughout the 24h time period after randomization Nicardipine was the first line antihypertensive agent Labetalol * was used as second agent

33 Trial Interventions Methods Primary treatment failure: not reaching the target SBP within 2 hours of randomization Secondary treatment failure: the hourly minimum SBP remaining higher than the upper limit of the target range for 2 consecutive hours during the initial 24h period

34 Trial Assessments Methods A non-contrast CTH was obtained 24 hours after the initiation of treatment, and both the baseline and 24h scan were forwarded The reader determined the site of hemorrhage, the presence/absence of blood, and the volume of the hematoma

35 Trial Assessments Methods Follow up via telephone interview at 1 month Follow up in clinic at 3 months Outcome Measures Primary outcome: proportion of patients who had moderately severe - severe disability or died at 3 months Secondary outcomes: scores on the EQ-5D utility index and VAS at 3 months, and the proportion of participants with 33% or greater volume expansion of their hematoma

36 Statistical Analysis Methods Primary hypothesis: Intensive treatment would be associated with a likelihood of death and disability at 3 months after ICH that was at least 10 percentage points lower than the likelihood associated with standard treatment Required sample size of 1042 patients Enrollment was stopped because of futility after the pre-specified second interim analysis

37 Results Enrollment period: May 2011 September sites in the U.S., Japan, China, Taiwan, South Korea, and Germany 1000 patients were randomized

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39 Results Primary treatment failure occurred in 12.2 % of in the intensive treatment group and 0.8% in the standard group Secondary treatment failure occurred in 15.6% of the intensive treatment group and 1.4 % in the standard group Death or disability was observed in 38.7% in the intensive group and 37.7% in the standard group

40 Results No significant difference noted between the 2 groups: Modified Rankin score at 3 months EQ-5D measure Percentage of patient with hematoma expansion Rate of death at 3 months Neurological deterioration at 24 hours

41 Limitations Trial incorporated the pre-randomization use of IV antihypertensive medications A high percentage of patients with favorable characteristics may have conferred a predisposition to a favorable outcome in the trial s sample regardless of treatment

42 Conclusion Results suggest that aggressive reduction of SBP to mmhg does not provide any clinical benefit

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44 Background Chest compressions are frequently interrupted by ventilations during out-of-hospital CA One strategy to reduce the interruption of compressions is to provide asynchronous PPV Observational studies have suggested that continuous compressions are associated with higher survival rates

45 Objective Compare whether continuous chest compressions vs. chest compressions interrupted for ventilation during CPR affected the rate of survival, neurological function, or rate of adverse events

46 Study design Methods Included 8 ROC site and 114 EMS agencies Informed consent was waived given the study involved research in emergency medicine Patient population Inclusion criteria Adults with non-trauma related out-ofhospital CA Exclusion criteria EMS witnessed arrest Advance directive with DNR Traumatic injury Asphyxial cause of arrest Exsanguination Known pregnancy Preexisting trach Known prisoners Had CPR performed by non ROC EMS providers or a mechanical device

47 Methods Study interventions 114 participating EMS agencies were grouped into 47 clusters Twice a year each cluster was crossed over Control group: 30 compressions:2 ventilations Intervention group: 100 compressions: 10 ventilations Outcomes Primary outcome: rate of survival to hospital discharge

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50 Limitations Mean difference in the chest compression fraction was small There was an imbalance in the number of patients assigned to each group The quality of post resuscitation care is associated with outcomes, but was not mandated in the study Oxygenation or minutes of ventilation delivered were not measured

51 Conclusion Continuous chest compressions with PPV did not result in significantly higher rates of survival or favorable neurologic status than the rates with interrupted chest compressions

52 References Anderson C, et al. Rapid blood pressure lowering in patients with acute intracerebral hemorrhage. NEJM. 2013;368(25): Cronberg T, et al. Neurologic function and health-related quality of life in patients following targeted temperature management at 33 o C vs 36 o C after out-of-hospital cardiac arrest. JAMA Neurol. 2015;133(6): Nichol G, et al. Trial of continuous or interrupted chest compressions during CPR. NEJM. 2015; 373(23): Qureshi A, et al. Intensive blood pressure lowering in patient with acute cerebral hemorrhage. NEJM. June 2016; doi: /nejmoa Young P, et al. Effect of a buffered crystalloid solution vs saline on acute kidney injury among patients in the intensive care unit. JAMA. 2015;314(16):

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