Esmolol May Stabilize Heart Rate in Septic Shock Patients.


For patients in septic shock who have an excessively high heartbeat, use of the beta blocker esmolol helped to lower and maintain heartbeat rates without adverse effects.

Andrea Morelli, MD, from the Department of Anesthesiology and Intensive Care, University of Rome, “La Sapienza,” Italy, and colleagues conducted a randomized phase 2 trial at the University of Rome hospital intensive care unit between November 2010 and July 2012. The researchers randomly assigned 154 patients whose heartbeats exceeded 95 beats per minute (BPM) and who required high doses of norepinephrine to receive either continuous infusion of esmolol to maintain heart rate between 80 and 94 BPM (n = 77) or to receive standard treatment (n = 77) of norepinephrine during intensive care unit stays.

The target heartbeat rate was achieved in all patients in the esmolol group and was significantly lower than for patients in the control group. The median heart rate reduction came to −28 BPM for the esmolol group compared with −6 BPM for the control group (P < .001). The median continuously infused dose for esmolol was 100 mg/h (interquartile range [IQR], 50 – 300 mg/h).

The mortality rate for the esmolol group came to 49.4% for the esmolol group compared with 80.5% for the control group (P < .001). Stroke volume index was significantly higher in the esmolol group (P = .02), as was the left ventricular stroke work index (P = .03). Fluid requirements were reduced in the esmolol group compared with controls (P < .001), although no clinically relevant differences existed between groups for some other cardiopulmonary variables.

“Compared with standard treatment, esmolol also increased stroke volume, maintained [mean arterial pressure], and reduced norepinephrine requirements without increasing the need of inotropic support or causing adverse effects on organ function,” the researchers write.

Because esmolol is short-acting and has a half-life of about 2 minutes, it enables rapid resolution of any potential adverse effects. These new findings, the researchers write, suggest esmolol “allows better ventricular filling during diastole, hence, improving stroke volume and thereby improving the efficiency of myocardial work and oxygen consumption.”

Limitations of the study include selection of a predefined arbitrary heart rate threshold and the requirement that the study be nonblinded and not placebo-controlled. In addition, results might not be similar in a less at-risk population.

Paves the Way

“This is the unblindable trial. There’s no way to blind this trial. That will always be a limitation of whatever comes down the road,” R. Phillip Dellinger, MD, professor and head of critical care medicine at Cooper University Hospital in Camden, New Jersey, told Medscape Medical News. Dr. Dellinger is first author of a recent articleon treatment guidelines for sepsis.

The new study, Dr. Dellinger said, “clears the way for a larger phase 3 trial, and it offers support for moving the physiology in the direction that would, on the surface, look beneficial. It shows that it’s safe. The secondary outcomes all moved in a positive direction or didn’t move at all. So there are no signals here of potential problems with doing this; instead there is evidence that it helps cardiac function.”

Some aspects of this phase 2 trial differ from many phase 2 trials, he added. “This trial picked a population that would be predicted to more likely benefit from beta blockage, which is requiring very high doses of norepinephrine and being tachycardic.” Limiting the trial population may be better than including a large population in a study and dividing them up in subgroup analyses, he said, but the results might not be generalizable to a larger population.

In summary, Dr. Dellinger said, “Even though the trial was small, I think it was encouraging.”

This research was funded by the Department of Anesthesiology and Intensive Care of the University of Rome, “La Sapienza.” Dr. Morelli reports receiving honoraria for speaking at Baxter symposia. One coauthor reports serving as a consultant for and receiving honoraria from speaking at Baxter. The other authors and Dr. Dellinger have disclosed no relevant financial relationships.

Effects of Patient-Directed Music Intervention on Anxiety and Sedative Exposure in Critically Ill Patients Receiving Mechanical Ventilatory SupportA Randomized Clinical Trial.


ABSTRACT

Importance  Alternatives to sedative medications, such as music, may alleviate the anxiety associated with ventilatory support.

Objective  To test whether listening to self-initiated patient-directed music (PDM) can reduce anxiety and sedative exposure during ventilatory support in critically ill patients.

Design, Setting, and Patients  Randomized clinical trial that enrolled 373 patients from 12 intensive care units (ICUs) at 5 hospitals in the MinneapolisSt Paul, Minnesota, area receiving acute mechanical ventilatory support for respiratory failure between September 2006 and March 2011. Of the patients included in the study, 86% were white, 52% were female, and the mean (SD) age was 59 (14) years. The patients had a mean (SD) Acute Physiology, Age and Chronic Health Evaluation III score of 63 (21.6) and a mean (SD) of 5.7 (6.4) study days.

Interventions  Self-initiated PDM (n = 126) with preferred selections tailored by a music therapist whenever desired while receiving ventilatory support, self-initiated use of noise-canceling headphones (NCH; n = 122), or usual care (n = 125).

Main Outcomes and Measures  Daily assessments of anxiety (on 100-mm visual analog scale) and 2 aggregate measures of sedative exposure (intensity and frequency).

Results  Patients in the PDM group listened to music for a mean (SD) of 79.8 (126) (median [range], 12 [0-796]) minutes/day. Patients in the NCH group wore the noise-abating headphones for a mean (SD) of 34.0 (89.6) (median [range], 0 [0-916]) minutes/day. The mixed-models analysis showed that at any time point, patients in the PDM group had an anxiety score that was 19.5 points lower (95% CI, −32.2 to −6.8) than patients in the usual care group (P = .003). By the fifth study day, anxiety was reduced by 36.5% in PDM patients. The treatment × time interaction showed that PDM significantly reduced both measures of sedative exposure. Compared with usual care, the PDM group had reduced sedation intensity by −0.18 (95% CI, −0.36 to −0.004) points/day (P = .05) and had reduced frequency by −0.21 (95% CI, −0.37 to −0.05) points/day (P = .01). The PDM group had reduced sedation frequency by −0.18 (95% CI, −0.36 to −0.004) points/day vs the NCH group (P = .04). By the fifth study day, the PDM patients received 2 fewer sedative doses (reduction of 38%) and had a reduction of 36% in sedation intensity.

Conclusions and Relevance  Among ICU patients receiving acute ventilatory support for respiratory failure, PDM resulted in greater reduction in anxiety compared with usual care, but not compared with NCH. Concurrently, PDM resulted in greater reduction in sedation frequency compared with usual care or NCH, and greater reduction in sedation intensity compared with usual care, but not compared with NCH.

Source: JAMA

 

 

Music Therapy in the ICU — Another Way to Lower Sedation Use?


Awake intensive care unit patients who received music therapy were less anxious than those who did not.

 

Music therapy improves well-being in hospice patients, distracts patients during endoscopy, and helps treat depression in elders. Could it also decrease anxiety in critically ill patients?

Investigators randomized 373 awake and interactive intensive care unit (ICU) patients to one of three groups: patient-directed music through noise-cancelling headphones (with a visit by a music therapist to find preferred music and twice-daily prompts to listen to music), patient-initiated noise-cancelling headphone use only, or usual care. Anxiety was assessed daily with a 100-point visual-analog scale (VAS; range, 0 = “not anxious at all” to 100 = “most anxious ever”), and sedation doses and frequency were analyzed post hoc.

During a mean follow-up of 6 days, daily VAS scores of patients who received patient-directed music were significantly lower (by a mean of 19 points) than those of patients who received usual care; the headphones-alone group scored nonsignificantly lower (by a mean of 8 points) than the usual-care group. Sedation use was somewhat lower in the music-treated group.

Comment: As an editorialist notes, this trial has several limitations, including lack of a standardized sedation protocol and use of an unvalidated anxiety-assessment tool. Despite this, the results suggest that an inexpensive intervention like patient-directed music in the ICU could help limit use of sedating medications and all the complications associated with them.

 

Source: Journal Watch General Medicine

A Randomized Trial of Glutamine and Antioxidants in Critically Ill Patients.


 

Critically ill patients have considerable oxidative stress. Glutamine and antioxidant supplementation may offer therapeutic benefit, although current data are conflicting.

METHODS

In this blinded 2-by-2 factorial trial, we randomly assigned 1223 critically ill adults in 40 intensive care units (ICUs) in Canada, the United States, and Europe who had multiorgan failure and were receiving mechanical ventilation to receive supplements of glutamine, antioxidants, both, or placebo. Supplements were started within 24 hours after admission to the ICU and were provided both intravenously and enterally. The primary outcome was 28-day mortality. Because of the interim-analysis plan, a P value of less than 0.044 at the final analysis was considered to indicate statistical significance.

RESULTS

There was a trend toward increased mortality at 28 days among patients who received glutamine as compared with those who did not receive glutamine (32.4% vs. 27.2%; adjusted odds ratio, 1.28; 95% confidence interval [CI], 1.00 to 1.64; P=0.05). In-hospital mortality and mortality at 6 months were significantly higher among those who received glutamine than among those who did not. Glutamine had no effect on rates of organ failure or infectious complications. Antioxidants had no effect on 28-day mortality (30.8%, vs. 28.8% with no antioxidants; adjusted odds ratio, 1.09; 95% CI, 0.86 to 1.40; P=0.48) or any other secondary end point. There were no differences among the groups with respect to serious adverse events (P=0.83).

CONCLUSIONS

Early provision of glutamine or antioxidants did not improve clinical outcomes, and glutamine was associated with an increase in mortality among critically ill patients with multiorgan failure.

Source: Nejm

 

 

A Randomized Trial of Glutamine and Antioxidants in Critically Ill Patients.


 

Critically ill patients have considerable oxidative stress. Glutamine and antioxidant supplementation may offer therapeutic benefit, although current data are conflicting.

METHODS

In this blinded 2-by-2 factorial trial, we randomly assigned 1223 critically ill adults in 40 intensive care units (ICUs) in Canada, the United States, and Europe who had multiorgan failure and were receiving mechanical ventilation to receive supplements of glutamine, antioxidants, both, or placebo. Supplements were started within 24 hours after admission to the ICU and were provided both intravenously and enterally. The primary outcome was 28-day mortality. Because of the interim-analysis plan, a P value of less than 0.044 at the final analysis was considered to indicate statistical significance.

RESULTS

There was a trend toward increased mortality at 28 days among patients who received glutamine as compared with those who did not receive glutamine (32.4% vs. 27.2%; adjusted odds ratio, 1.28; 95% confidence interval [CI], 1.00 to 1.64; P=0.05). In-hospital mortality and mortality at 6 months were significantly higher among those who received glutamine than among those who did not. Glutamine had no effect on rates of organ failure or infectious complications. Antioxidants had no effect on 28-day mortality (30.8%, vs. 28.8% with no antioxidants; adjusted odds ratio, 1.09; 95% CI, 0.86 to 1.40; P=0.48) or any other secondary end point. There were no differences among the groups with respect to serious adverse events (P=0.83).

CONCLUSIONS

Early provision of glutamine or antioxidants did not improve clinical outcomes, and glutamine was associated with an increase in mortality among critically ill patients with multiorgan failure.

Source: Nejm

Tight Glycemic Control Doesn’t Improve Outcomes After Kids’ Cardiac Surgery.


Tight glucose control in pediatric ICU patients following cardiac surgery does not reduce morbidity or mortality, according to a study in the New England Journal of Medicine.

Nearly 1000 children (up to age 36 months) who were admitted to the cardiac ICU after undergoing cardiopulmonary bypass were randomized to receive either tight glycemic control with insulin or standard care. Those with diabetes were excluded.

Overall, the number of healthcare-associated infections (e.g., pneumonia, bloodstream infections) did not differ significantly between the groups. There were also no differences in 30-day or in-hospital mortality; length of ICU or hospital stay; or duration of mechanical ventilation or vasoactive support.

An NEJM editorialist argues why these findings should supersede those from a 2009 study showing a benefit with tight glycemic control. He concludes that the door “should be closed on the routine normalization of plasma glucose in critically ill adults and children.”

Source: NEJM