Analgesia-first sedation in critically ill adults: A U.S. pilot, randomized controlled trial

This research by Tanios and colleagues was first published online in June 2019 in the Journal of Critical Care.
Purpose:  To determine the feasibility of conducting a multicenter ICU RCT of AFS compared to either protocol-directed sedation (PDS) or both PDS and daily sedation interruption (DSI) in North America.
Materials and methods:  This single-center RCT compared AFS with either PDS or both PDS and DSI daily in adults mechanically ventilated (MV) ≥48 h. Relevant feasibility, safety, and clinical outcomes were defined and evaluated.
Results:  90 of 160 eligible patients were enrolled [AFS = 27; PDS = 28; PDS + DSI = 31]; rate = 3/month. Time from intubation to randomization was 17.5 ± 11.6 h. Study days fully adherent to the study intervention [AFS = 95%; PDS = 99%; PDS + DSI = 96%] and time spent in the first 48 h after randomization without pain (CPOT ≤2)[AFS = 82%; PDS = 78%; PDS + DSI = 77%] and at goal RASS[AFS = 88%; PDS = 83%; PDS + DSI = 95%] were high and similar. Nurse-perceived [median (IQR)] study workload (10-point VAS) was higher with AFS [4(2–6)] than PDS [1(1–3)] or PDS + DSI [2(1–5)]; p = .002). Unplanned extubation was rare (AFS = 1; PDS = 0; PDS + DSI = 1). Days [median (IQR)] free of MV in the 28d after intubation [AFS 24(23,26); PDS 24(20,26); PDS + DSI 24(21,26)] was not different (p = .62).
Conclusion:  A multicenter RCT evaluating AFS is feasible to conduct in North America.
The full text of this article is available to subscribers via this link to the journal’s homepage.  The full text of articles from issues older than sixty days is available via this link to an archive of issues of Journal of Critical Care.  A Rotherham NHS Athens password is required.  Eligible staff can register for an Athens password via this link.  Please speak to the library staff for more details.

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Variability in triage practices for critically ill cancer patients: A randomized controlled trial

This article by Rathi and others was published online in May 2019 in the “Journal of Critical Care”.
Purpose:  Intensive care triage practices and end-user interpretation of triage guidelines have rarely been assessed. We evaluated agreement between providers on the prioritization of patients for ICU admission using different triage guidelines.
Materials and methods:  A multi-centered randomized study on providers from 18 different countries was conducted using clinical vignettes of oncological patients. The level of agreement between providers was measured using two different guidelines, with one being cancer specific.
Results:  Amongst 257 providers, 52.5% randomly received the Society of Critical Care Prioritization Model, and 47.5% received a cancer specific flowchart as a guide. In the Prioritization Model arm the average entropy was 1.193, versus 1.153 in the flowchart arm (P = .095) indicating similarly poor agreement. The Fleiss’ kappa coefficients were estimated to be 0.2136 for the SCCMPM arm and 0.2457 for the flowchart arm, also similarly implying poor agreement.
Conclusions:  The low agreement amongst practitioners on the prioritization of cancer patient cases for ICU admission existed using both general triage guidelines and guidelines tailored only to cancer patients. The lack of consensus on intensive care unit triage practices in the oncological population exposes a potential barrier to appropriate resource allocation that needs to be addressed.
The full text of this article is available to subscribers via this link to the journal’s homepage.  The full text of articles from issues older than sixty days is available via this link to an archive of issues of Journal of Critical Care.  A Rotherham NHS Athens password is required.  Eligible staff can register for an Athens password via this link.  Please speak to the library staff for more details.

High versus low mean arterial pressures in hepatorenal syndrome: A randomized controlled pilot trial

There is controversy regarding the mean arterial pressure (MAP) goals that should be targeted in the treatment of hepatorenal syndrome (HRS.) We conducted a study to assess different MAP targets in HRS in the intensive care unit (ICU).
Materials and methods:  This is a prospective randomized controlled pilot trial. ICU patients had target mean arterial pressure (MAP) ≥ 85 mmHg (control arm) or 65–70 mmHg (study arm). Urine output and serum creatinine were trended and recorded.
Results:  A total of 18 patients were enrolled. The day four urine output in the high and low MAP group was 1194 (SD = 1249) mL/24 h and 920 (SD = 812) mL/24 h, respectively. The difference in day four – day one urine output was −689 (SD = 1684) mL/24 h and 272 (SD = 582) mL/24 h for the high and low MAP groups. The difference in serum creatinine at day four – day one was −0.54 (SD = 0.63) mg/dL and − 0.77 (SD = 1.14) mg/dL in the high and low MAP groups, respectively.
Conclusion:  In this study, we failed to prove non-inferiority between a low and high target MAP in patients with HRS.
The full text of this article is available to subscribers via this link to the journal’s homepage.  The full text of articles from issues older than sixty days is available via this link to an archive of issues of Journal of Critical Care.  A Rotherham NHS Athens password is required.  Eligible staff can register for an Athens password via this link.  Please speak to the library staff for more details.

Effect of physostigmine on recovery from septic shock following intra-abdominal infection – Results from a randomized, double-blind, placebo-controlled, monocentric pilot trial (Anticholium® per Se)

This research by Pinder et al was published online during April 2019 in the Journal of Critical Care.
Purpose:  The cholinergic anti-inflammatory pathway has been shown to be accessible by physostigmine salicylate in animal models. However, the cholinesterase inhibitor is not approved for adjunctive therapy in sepsis, and tolerability and safety of high initial doses followed by continuous infusion have not been investigated.
Materials and methods:  In this trial, 20 patients with perioperative septic shock due to intra-abdominal infection were eligible. The physostigmine group received an initial dose of 0.04 mg/kg physostigmine salicylate, followed by continuous infusion of 1 mg/h for 120 h; the placebo group was treated with 0.9% sodium chloride. Primary outcome was the mean Sequential Organ Failure Assessment (SOFA) score during treatment and up to 14 days.
Results:  Administration of physostigmine salicylate was well tolerated. Mean SOFA scores were 8.9 ± 2.5 and 11.3 ± 3.6 (mean ± SD) for physostigmine and placebo group, respectively. Adjusted for age, difference between means was not statistically significant (−2.37, 95% CI: -5.43 to 0.70, p = 0.121). Norepinephrine doses required only appeared lower in the physostigmine group (p = 0.064), along with a more rapid reduction from an elevated heart rate possibly indicating less hemodynamic instability.
Conclusions:  Treatment with physostigmine salicylate was feasible and safe. Further studies are justified to assess the effect on recovery from septic shock.
The full text of this article is available to subscribers via this link to the journal’s homepage.  The full text of articles from issues older than sixty days is available via this link to an archive of issues of Journal of Critical Care.  A Rotherham NHS Athens password is required.  Eligible staff can register for an Athens password via this link.  Please speak to the library staff for more details.

The hospital-based evaluation of laxative prophylaxis in ICU (HELP-ICU): A pilot cluster-crossover randomized clinical trial

This article by Hay and colleagues was published online in the Journal of Critical Care in April 2019.
Purpose:  Prophylactic laxative regimens may prevent constipation but may increase diarrhea and subsequent rectal tube insertion. Our aim was to compare three prophylactic laxative regimens on the rate of rectal tube insertion (primary outcome) and major constipation- or diarrhea-associated complications.
Material and Methods:  We conducted a cluster-crossover trial. Three pods in a single ICU were each randomized to one of three regimens for four months with rolling cross-over. All mechanically-ventilated and enterally-fed adult patients received either regimen: A) one coloxyl with senna BD from day one; B) two coloxyl with senna +20 ml lactulose BD commencing on day 3; or C) two coloxyl with senna tablets +20 ml lactulose BD commencing on day 6.
Results:  We enrolled 570 patients (A = 170, B = 205, C = 195) with similar baseline features. Overall, 53 (9.3%) patients received a rectal tube, and insertion rate was not statistically different between the three regimens (A = 12.9%, B = 7.8%, C = 7.7%; p = 0.15). The proportions of patients with other major constipation- or diarrhea-associated complications were similar, as were major patient-centred outcomes. Including mortality.
Conclusion:  Earlier commencement of a prophylactic coloxyl-based laxative regimen (day 1 or 3) did not affect the rates of complications associated with constipation or diarrhea when compared to delayed introduction (day 6).
The full text of this article is available to subscribers via this link to the journal’s homepage.  The full text of articles from issues older than sixty days is available via this link to an archive of issues of Journal of Critical Care.  A Rotherham NHS Athens password is required.  Eligible staff can register for an Athens password via this link.  Please speak to the library staff for more details.

Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial.

This article by Hernandez and others was published in JAMA in February 2019 (volume 321 number 7 pages 654-664)
Importance:  Abnormal peripheral perfusion after septic shock resuscitation has been associated with organ dysfunction and mortality. The potential role of the clinical assessment of peripheral perfusion as a target during resuscitation in early septic shock has not been established.
Objective:  To determine if a peripheral perfusion-targeted resuscitation during early septic shock in adults is more effective than a lactate level-targeted resuscitation for reducing mortality.
Design, Setting, and Participants:  Multi-centre, randomized trial conducted at 28 intensive care units in 5 countries. Four-hundred twenty-four patients with septic shock were included between March 2017 and March 2018. The last date of follow-up was June 12, 2018.
Interventions: Patients were randomized to a step-by-step resuscitation protocol aimed at either normalizing capillary refill time (n = 212) or normalizing or decreasing lactate levels at rates greater than 20% per 2 hours (n = 212), during an 8-hour intervention period.
Main Outcomes and Measures:  The primary outcome was all-cause mortality at 28 days. Secondary outcomes were organ dysfunction at 72 hours after randomization, as assessed by Sequential Organ Failure Assessment (SOFA) score (range, 0 [best] to 24 [worst]); death within 90 days; mechanical ventilation-, renal replacement therapy-, and vasopressor-free days within 28 days; intensive care unit and hospital length of stay.
Results:  Among 424 patients randomized (mean age, 63 years; 226 [53%] women), 416 (98%) completed the trial. By day 28, 74 patients (34.9%) in the peripheral perfusion group and 92 patients (43.4%) in the lactate group had died (hazard ratio, 0.75 [95% CI, 0.55 to 1.02]; P = .06; risk difference, -8.5% [95% CI, -18.2% to 1.2%]). Peripheral perfusion-targeted resuscitation was associated with less organ dysfunction at 72 hours (mean SOFA score, 5.6 [SD, 4.3] vs 6.6 [SD, 4.7]; mean difference, -1.00 [95% CI, -1.97 to -0.02]; P = .045). There were no significant differences in the other 6 secondary outcomes. No protocol-related serious adverse reactions were confirmed.
Conclusions and Relevance:  Among patients with septic shock, a resuscitation strategy targeting normalization of capillary refill time, compared with a strategy targeting serum lactate levels, did not reduce all-cause 28-day mortality
The print copy of this issue JAMA is available in the Healthcare Library on D Level of Rotherham General Hospital.

Effects of a Multimodal Program Including Simulation on Job Strain Among Nurses Working in Intensive Care Units: A Randomized Clinical Trial

This article by El Khamali and others was published inJAMA during November 2018.
Importance:  Nurses working in an intensive care unit (ICU) are exposed to occupational stressors that can increase the risk of stress reactions, long-term absenteeism, and turnover.
Objective:  To evaluate the effects of a program including simulation in reducing work-related stress and work-related outcomes among ICU nurses.
Design, Setting, and Participants:  Multi-center randomized clinical trial performed at 8 adult ICUs in France from February 8, 2016, through April 29,2017. A total of 198 ICU nurses were included and followed up for 1 year until April 30, 2018.
Interventions:  The ICU nurses who had at least 6 months of ICU experience were randomized to the intervention group (n = 101) or to the control group (n = 97). The nurses randomized to the intervention group received a 5-day course involving a nursing theory recap and situational role-play using simulated scenarios (based on technical dexterity, clinical approach, decision making, aptitude to teamwork, and task prioritization),which were followed by debriefing sessions on attitude and discussion of practices.
Main Outcomes and Measures:  The primary outcome was the prevalence of job strain assessed by combining a psychological demand score greater than 21(score range, 9 [best] to 36 [worst]) with a decision latitude score less than 72 (score range, 24 [worst] to 96 [best]) using the Job Content Questionnaire and evaluated at 6 months. There were 7 secondary outcomes including absenteeism and turnover.
Results:  Among 198 ICU nurses who were randomized (95 aged ≤30 years [48%] and 115 women [58%]),182 (92%) completed the trial for the primary outcome. The trial was stopped for efficacy at the scheduled interim analysis after enrollment of 198 participants. The prevalence of job strain at 6 months was lower in the intervention group than in the control group (13% vs 67%, respectively;between-group difference, 54% [95% CI, 40%-64%]; P < .001). Absenteeism during the 6-month follow-up period was 1% in the intervention group compared with 8% in the control group (between-group difference, 7% [95% CI, 1%-15%];P = .03). Four nurses (4%) from the intervention group left the ICU during the 6-month follow-up period compared with 12 nurses (12%) from the control group(between-group difference, 8% [95% CI, 0%-17%]; P = .04).
Conclusions and Relevance:  Among ICU nurses, an intervention that included education, role-play, and debriefing resulted in a lower prevalence of job strain at 6 months compared with nurses who did not undergo this program.Further research is needed to understand which components of the program may have contributed to this result and to evaluate whether this program is cost-effective.
The print copy of this issue JAMA is available in the Healthcare Library on D Level of Rotherham General Hospital.