Restricted fluid resuscitation in suspected sepsis associated hypotension (REFRESH): a pilot randomised controlled trial

Purpose

To determine if a regimen of restricted fluids and early vasopressor compared to usual care is feasible for initial resuscitation of hypotension due to suspected sepsis.

Methods

A prospective, randomised, open-label, clinical trial of a restricted fluid resuscitation regimen in the first 6 h among patients in the emergency department (ED) with suspected sepsis and a systolic blood pressure under 100 mmHg, after minimum 1000 ml of IV fluid. Primary outcome was total fluid administered within 6 h post randomisation.

Results

There were 99 participants (50 restricted volume and 49 usual care) in the intention-to-treat analysis. Median volume from presentation to 6 h in the restricted volume group was 2387 ml [first to third quartile (Q1–Q3) 1750–2750 ml]; 30 ml/kg (Q1–Q3 32–39 ml/kg) vs. 3000 ml (Q1–Q3 2250–3900 ml); 43 ml/kg (Q1–Q3 35–50 ml/kg) in the usual care group (p?<?0.001). Median duration of vasopressor support was 21 h (Q1–Q3 9–42 h) vs. 33 h (Q1–Q3 15–50 h), (p?=?0.13) in the restricted volume and usual care groups, respectively. At 90-days, 4 of 48 (8%) in the restricted volume group and 3 of 47 (6%) in the usual care group had died. Protocol deviations occurred in 6/50 (12%) in restricted group and 11/49 (22%) in the usual care group, and serious adverse events in four cases (8%) in each group.

Conclusions

A regimen of restricted fluids and early vasopressor in ED patients with suspected sepsis and hypotension appears feasible. Illness severity was moderate and mortality rates low. A future trial is necessary with recruitment of high-risk patients to determine effects on clinical outcomes in this setting.

     

Balanced crystalloids versus normal saline for fluid resuscitation in critically ill patients: A systematic review and meta-analysis with trial sequential analysis

IntroductionFluid resuscitation is a fundamental component of the management of critically ill patients, but whether choice of crystalloid affects patient outcomes remains controversial. Therefore, we performed this meta-analysis to compare the efficacy and safety of balanced crystalloids with normal saline.MethodsWe searched the MEDLINE, Cochrane Central and EMBASE up to October 2018 to identify randomized controlled trials (RCTs) that compared balanced crystalloids versus normal saline in critically ill patients. The primary outcome was mortality. The secondary results were the incidence of acute kidney injury (AKI) and risk of receiving renal replacement therapy (RRT). Two authors independently screened articles based on the inclusion and exclusion criteria. The meta-analysis was conducted using Revman 5.3, trial sequential analysis (TSA) 0.9 and STATA 12.0.ResultsNine RCTs were identified. The pooled analyses showed that there were no significant differences in mortality (relative risk (RR) = 0.93, 95% confidence interval (CI) = 0.86, 1.01, P = 0.08), incidence of AKI (RR 0.94, 95% CI 0.88, 1.00, P = 0.06) or RRT use rate (RR 0.94, 95% CI 0.69, 1.27, P = 0.67) between balanced crystalloids and normal saline groups. However, TSA did not provide conclusive evidence.ConclusionsAmong critically ill patients receiving crystalloid fluid therapy, use of a balanced crystalloid compared with normal saline did not reduce the mortality, risk of severe AKI or RRT use rate. Further large randomized clinical trials are needed to confirm or refute this finding.Trial registrationA protocol of this meta-analysis has been registered on PROSPERO (registration number: CRD42018094857).     

Aggressive versus conservative fluid resuscitation in septic hemodialysis patients

PurposeSepsis and bacterial infections are common in patients with end-stage renal disease (ESRD). We aimed to compare patients with ESRD on hemodialysis presenting to hospital with severe sepsis or septic shock who received <20 ml/kg of intravenous fluid to those who received ≥20 ml/kg during initial resuscitation.Materials and methodsWe conducted a retrospective chart review of adult patients with ICD codes for discharge diagnosis of sepsis, severe sepsis, septic shock, ESRD, and hemodialysis admitted to our institution between 2015 and 2018.ResultsWe present outcomes for a total of 104 patients — 51 patients in conservative group and 53 in aggressive group. The mean age was 69.5 ± 11.2 years and 71 ± 11.5 years in the conservative group and aggressive group, respectively. There was no significant difference in the rate of ICU admission, and ICU or hospital length of stay between the two groups. Complications such as volume overload, rate of intubation, and urgent dialysis were not found to be significantly different.ConclusionWe found that aggressive fluid resuscitation with ≥20 ml/kg may not be detrimental in the initial resuscitation of ESRD patients with SeS or SS. However, a clinical decision of volume responsiveness should be made on a case-by-case basis rather than a universal approach for fluid resuscitation in ESRD patients.     

Vocational performance tests for brain-injured patients: a follow-up study

Work hardening programmes are suggested for brain-injured patients who were unemployed during the rehabilitation period or could not return to their previous job due to specific impairments. The aim of this vocational intervention is to obtain information about the chance of competitive re-employment and about potential obstacles preventing it. In 1994 the city of Munich has established opportunities to perform work hardening programmes in selected municipal work domains. Between 1994 and 1998, 28 patients from the neuropsychological department of the Munich-Bogenhausen municipal hospital underwent such an intervention. 18 persons could be contacted for structured telephone interviews addressing their work histories after discharge from the rehabilitation unit. Three former patients who had retired immediately after the work hardening intervention did not attempt to resume working. Among the remaining 15 patients, six were able to resume full-time competitive work at follow-up, four persons were still employed but had been forced to limit work demands, and five persons had retired. A positive course of reintegration was seen in three patients who received a special vocational support following the work hardening intervention at the same place of work. A negative outcome resulted in four persons who were recommended to participate in vocational retraining. A poor general life satisfaction was reported particularly by retired persons.     

Peer-led resuscitation training for healthcare students: a randomised controlled study

OBJECTIVE: To determine the efficacy of a peer-led tuition model for training healthcare students in basic life support compared to tuition delivered by clinical tutors. DESIGN AND SETTING: Randomised controlled trial in the Medical School, University of Birmingham, UK. PARTICIPANTS: 122 first-year medical, dental, nursing and physiotherapy students. INTERVENTIONS: Students were randomised to receive basic life support tuition from either second-year student instructors or from experienced clinical staff. MEASUREMENTS AND RESULTS: Students' practical skills, knowledge and satisfaction were tested at the end of the course. Instructor reliability was assessed throughout the course. Students taught by their peers were significantly more likely to be successful in the end-of-course practical CPR test than those taught by clinical staff (56/57 vs. 53/62). The student instructors were also found to be more reliable than clinical staff at attending the training sessions (48/48 vs. 36/48). There was no significant difference in the theoretical test results or the students' assessment of the quality of teaching. CONCLUSIONS: This model of peer-led undergraduate training in basic life support provides a quality of education which is at least as good as that provided by clinical staff, while offering advantages in terms of reliability. The re-deployment of clinical tutors from basic to more advanced training may allow the overall enhancement of undergraduate resuscitation and critical care training.     

Indobufen versus placebo in the prevention of restenosis after carotid endarterectomy: a double-blind pilot study

A randomized clinical trial was undertaken to assess the efficacy of indobufen in inhibiting platelet adhesiveness in carotid thromboendarterectomy. The patients were treated under double-blind conditions with indobufen and with placebo, and were then assessed by means of scintigraphy with labelled platelets, ultrasonic tomography and angiography for a minimum follow-up period of 6 months. Haematological and clinical assessments were also performed. The results of the study suggest that platelet accumulation in carotid endarterectomy may be an early sign of restenosis; anti-aggregant treatment with indobufen carried out at an early stage prior to surgery inhibited platelet accumulation. The final result showed that anti-aggregant treatment had a positive influence on the short- and medium-term outcome of carotid endarterectomy.     

Melatonin versus placebo in the prophylaxis of cluster headache: a double-blind pilot study with parallel groups

A fall in nocturnal plasma melatonin occurs in patients with cluster headache, suggesting that melatonin may play a role in the promotion of attacks. During a cluster period, we administered melatonin to 20 cluster headache patients (2 primary chronic, 18 episodic) in a double-blind placebo-controlled study of oral melatonin 10 mg ( n =10) or placebo ( n =10) for 14 days taken in a single evening dose. Headache frequency was significantly reduced (ANOVA, p <0.03) and there were strong trends towards reduced analgesic consumption (ANOVA, p <0.06) in the treatment group. Five of the 10 treated patients were responders whose attack frequency declined 3–5 days after treatment, and they experienced no further attacks until melatonin was discontinued. The chronic cluster patients did not respond. No patient in the placebo group responded. There were no side effects in either group. Although the response rate is low, melatonin may be suitable for cluster headache prophylaxis in some patients, particularly those who cannot tolerate other drugs.     

Motion detection technology as a tool for cardiopulmonary resuscitation (CPR) quality training: A randomised crossover mannequin pilot study

Introduction

Outcome after cardiac arrest is dependent on the quality of chest compressions (CC). A great number of devices have been developed to provide guidance during CPR. The present study evaluates a new CPR feedback system (Mini-VREM: Mini-Virtual Reality Enhanced Mannequin) designed to improve CC during training.

Methods

Mini-VREM system consists of a Kinect^® (Microsoft, Redmond, WA, USA) motion sensing device and specifically developed software to provide audio–visual feedback. Mini-VREM was connected to a commercially available mannequin (Laerdal Medical, Stavanger, Norway). Eighty trainees (healthcare professionals and lay people) volunteered in this randomised crossover pilot study. All subjects performed a 2 min CC trial, 1 h pause and a second 2 min CC trial. The first group (FB/NFB, n = 40) performed CC with Mini-VREM feedback (FB) followed by CC without feedback (NFB). The second group (NFB/FB, n = 40) performed vice versa. Primary endpoints: adequate compression (compression rate between 100 and 120 min⁻¹ and compression depth between 50 and 60 mm); compressions rate within 100–120 min⁻¹; compressions depth within 50–60 mm.

Results

When compared to the performance without feedback, with Mini-VREM feedback compressions were more adequate (FB 35.78% vs. NFB 7.27%, p < 0.001) and more compressions achieved target rate (FB 72.04% vs. 31.42%, p < 0.001) and target depth (FB 47.34% vs. 24.87%, p = 0.002). The participants perceived the system to be easy to use with effective feedback.

Conclusions

The Mini-VREM system was able to improve significantly the CC performance by healthcare professionals and by lay people in a simulated CA scenario, in terms of compression rate and depth.     

Case managers for frail older people: a randomised controlled pilot study

Scand J Caring Sci; 2010; 24; 755–763
Case managers for frail older people; a randomised controlled pilot study Aim: The aim was to test sampling and explore sample characteristics in a pilot study using a case management intervention for older people with functional dependency and repeated contact with the healthcare services as well as to investigate the effects of the intervention on perceived health and depressed mood after 3 months. The aim was also to explore internal consistency in the life satisfaction index Z, activities of daily living‐staircase and Geriatric Depression Scale‐20. Method: This pilot study was carried out in a randomised controlled design with repeated follow‐ups. In all, 46 people were consecutively and randomly assigned to either an intervention (n = 23) or a control (n = 23) group. Two nurses worked as case managers and carried out the intervention, which consisted of four parts. Result: No differences were found between the groups at baseline. The results showed the participants had low life satisfaction (median 14 vs. 12), several health complaints (median 11) and a high score on the Geriatric Depression Scale (median 6) at baseline, indicating the risk of depression. No significant effects were observed regarding depressed mood or perceived health between or within groups at follow‐up after 3 months. Cronbach′s alpha showed satisfactory internal consistency for group comparisons. Conclusions: The sampling procedure led to similar groups. The life satisfaction, functional dependency and symptoms of depression measures were reliable to use. No changes in perceived health and symptoms of depression were found after 3 months, indicating that it may be too early to expect effects. The low depression score is noteworthy and requires further research.     

Outcomes of cardiopulmonary resuscitation for patients on vasopressors or inotropes: A pilot study

Hypothesis

Outcomes of critically ill patients who receive cardiopulmonary resuscitation (CPR) are poor, and the subgroup on vasopressors or inotropes before cardiopulmonary arrest (CPA) rarely survives.

Setting

The setting of the study was a critical care unit of a 350-bed community teaching hospital.

Study Design

This was a retrospective, cohort study.

Methods

A retrospective review was performed of medical records of all patients, identified through medical billing and hospital committee records, who received CPR for CPA in a critical care unit.

Results

Of 83 patients, with an average age of 66 years, 14 (17%) survived to hospital discharge. Patients with pulseless electrical activity and asystole were significantly less likely to survive (9% and none, respectively; P = .0001). Only 2 (4%) of 55 critically ill patients receiving vasopressors before CPR survived, whereas 12 of 28 patients not on vasopressors survived (P < .0001). Although mechanical ventilation just before CPR was highly associated with administration of vasopressors, ventilation was not significantly associated with mortality (P = .13). Mortality of patients on vasopressors was higher for both mechanically ventilated (95% vs 33%, P < .001) and spontaneously breathing (100% vs 64%, P = .02) patients. In multiple logistic regression analyses, administration of vasopressors was the only variable independently associated with in-hospital mortality (odds ratio, 35.1; 95% confidence interval = 4.1-304.3).

Conclusions

Survival of patients requiring CPR during critical care admission was 17%. Very few patients survived who required vasopressors or inotropes immediately before CPA. This study is limited significantly by its retrospective design and small cohort, and so this question should be reexamined in a larger study.     

Hormonal changes with cholesterol reduction: a double-blind pilot study

BACKGROUND: The lowering of high serum cholesterol levels may be associated with increased non-cardiac mortality due to behavioral changes, although such endpoints are likely rare. OBJECTIVE: This current study sought to determine if hormonal changes accompany pharmacologically induced decreases in serum cholesterol levels. METHOD: Cholesterol, dopamine, homovanillic acid (HVA), serotonin, 5-HIAA, testosterone, cortisol and pregnenolone were measured at baseline and after 4 weeks of treatment. RESULTS: Subjects' cholesterol levels significantly declined within 4 weeks. Concomitant significant increase in dopamine and HVA were noted. CONCLUSION: Although this study is limited in size, it raises the possibility that cholesterol-lowering drug treatment is associated with hormonal perturbations.     

Effectiveness of mechanical versus manual chest compressions in out-of-hospital cardiac arrest resuscitation: A pilot study

A prospective, randomized effectiveness trial was undertaken to compare mechanical versus manual chest compressions as measured by end-tidal CO₂ (etco₂) in out-of-hospital cardiac arrest patients receiving advanced cardiac life support (ACLS) resuscitation from a municipal third-service, emergency medical services (EMS) agency. The EMS agency responds to approximately 6,700 emergencies annually, 79 of which were cardiac arrests in 1994, the study year. Following endotracheal intubation, all cardiac arrest patients were placed on 100% oxygen via the ventilator circuit of the mechanical cardiopulmonary resuscitation (CPR) device. Patients were randomized to receive mechanical CPR (TCPR) or human/manual CPR (HCPR) based on an odd/even day basis, with TCPR being performed on odd days. etco₂ readings were obtained 5 minutes after the initiation of either TCPR or HCPR and again at the initiation of patient transport to the hospital. All patients received standard ACLS pharmacotherapy during the monitoring interval with the exception of sodium bicarbonate. CPR was continued until the patient was delivered to the hospital emergency department. Age, call response interval, initial electrocardiogram (ECG) rhythm, scene time, etco₂ measurements, and arrest outcome were identified for all patients. Twenty patients were entered into the study, with 10 in each treatment group. Three patients in the TCPR group were excluded. Measurements in the HCPR group revealed a decreasing etco₂ during the resuscitation in 8 of 10 patients (80%) and an increasing etco₂ in the remaining 2 patients. No decrease in etco₂ was noted in the TCPR group, with 4 of 7 patients (57%) actually showing an increased reading and 3 of 7 patients (43%) showing a constant etco₂ reading. The differences in the etco₂ measurements between TCPR and HCPR groups were statistically significant. Both groups were similar with regards to call response intervals, patient ages, scene times, and initial ECG rhythms. One patient in the TCPR group was admitted to the hospital but later died, leaving no survivors in the study. TCPR appears to be superior to standard HCPR as measured by etco₂ in maintaining cardiac output during ACLS resuscitation of out-of-hospital cardiac arrest patients.     

Dipyrone versus paracetamol: a double-blind study in typhoid fever

In a double-blind study in patients with typhoid fever 25 patients received 500 mg dipyrone and 28 received 500 mg paracetamol. Rectal temperature and pulse records were monitored every 30 min. The onset of anti-pyresis in patients given dipyrone (30 min) was significantly different from those given paracetamol (1 h). The area under the time-temperature curves was significantly greater for patients given dipyrone. The sum of the reduction in temperature at all times significantly favoured patients who had been given dipyrone. Both treatments were well tolerated.     

In-water resuscitation: a pilot evaluation

INTRODUCTION: The first and most important treatment for the apnoeic drowning victim is the rapid alleviation of hypoxia by artificial ventilation. Recent studies have suggested that commencing resuscitative efforts with the victim still in the water may be beneficial. The aim of this pilot study was to evaluate the feasibility and efficacy of in-water unsupported rescue breathing. METHODS: Three lifeguards were taught how to perform in-water unsupported rescue breathing. Ventilation volume, inflation duration were recorded from a modified Laerdal resuscitation manikin. The rescue duration was recorded and compared to a rescue undertaken without in-water resuscitation. RESULTS: The three lifeguards performed between seven and nine ventilations during each simulated rescue. This gave average inflation volumes for each lifeguard of 711 ml (S.D. 166), 750 ml (S.D. 108), 629 ml (S.D. 182) and average inflation duration of 0.8s (S.D. 0.3), 0.9s (S.D. 0.2) and 0.6s (S.D. 0.1). The rescue duration was increased from an average time of 1 min 10 s to 1 min 24 s by performing in-water resuscitation. CONCLUSION: This study has demonstrated the feasibility and potential efficacy of in-water unsupported rescue breathing with a victim in deep water. Furthermore, the technique was not associated with an undue prolongation of the rescue duration over a 50 m rescue. In circumstances where the trained lifeguard finds themselves with an apnoeic victim in the water, with no buoyant rescue aid available, they may consider the application of in-water, unsupported rescue breathing, especially if recovery to dry land is likely to be delayed. The effectiveness of this technique, however, remains to be proven in the open water environment.     

Home- versus hospital-laundered scrubs: a pilot study

PURPOSE: To determine the presence of pathogens on scrub attire that had been either laundered at home or in the hospital. STUDY DESIGN AND METHODS: Quasi-experimental research design with a convenience sample. The left front shoulders of home-laundered scrubs (n = 30) and hospital-laundered scrubs (n = 20) were cultured during the first 2 hours of a single workday. For the home-laundered scrubs, data were collected concerning home washing procedures, water temperature, pets in the home, and donning procedures. RESULTS: No pathogenic growth was found on either the hospital- or home-laundered scrubs. In addition, no relationships were found between home washing procedures, water temperature, pets in the home, and donning procedures. CLINICAL IMPLICATIONS: The results of this pilot study suggested that scrubs laundered both at home and in the hospital were free of pathogens, and that differing home washing procedures made no difference. Further investigation is necessary with larger numbers of subjects.