Long-term mortality in the Intermediate care after emergency abdominal surgery (InCare) trial-A post-hoc follow-up study.

BACKGROUND: Patients undergoing emergency abdominal surgery are at high risk of post-operative complications. Although post-operative treatment at an intermediate care unit may improve early outcome, there is a lack of studies on the long-term effects of such therapy. The aim of this study was to assess the long-term effect of intermediate care versus standard surgical ward care on mortality in the Intermediate Care After Emergency Abdominal Surgery (InCare) trial. METHODS: We included adult patients undergoing emergency major laparoscopy or laparotomy with an Acute Physiology and Chronic Health Evaluation (APACHE) II score of 10 or more, who participated in the InCare trial from October 2010 to November 2012. In the InCare trial, patients were randomized to either post-operative intermediate care or standard surgical ward care. The primary outcome was time to death within 6 years after surgery. We assessed mortality with Coxregression analysis. RESULTS: A total of 286 patients were included. The all-cause 6-year landmark mortality was 52.8% (76 of 144 patients) in the intermediate care group and 47.9% (68 of 142 patients) in the ward care group. There was no statistically significant difference in mortality risk between the two groups (hazard ratio 1.06 (95% confidence interval 0.76-1.47), P = .73). CONCLUSION: We found no statistically significant difference in 6-year mortality between patients randomized to post-operative intermediate care or ward care after emergency abdominal surgery. However, we detected an absolute mortality risk reduction of 5% in favour of ward care, possibly due to random error.

Patients' experiences of postoperative intermediate care and standard surgical ward care after emergency abdominal surgery: a qualitative sub-study of the Incare trial.

AIMS AND OBJECTIVES: To elicit knowledge of patient experiences of postoperative intermediate care in an intensive care unit and standard postoperative care in a surgical ward after emergency abdominal surgery. BACKGROUND: Emergency abdominal surgery is common, but little is known about how patients experience postoperative care. The patient population is generally older with multiple comorbidities, and the short-term postoperative mortality rate is 15-20%. Thus, vigilant surgeon and nursing attention is essential. The present study is a qualitative sub-study of a randomised trial evaluating postoperative intermediate care after emergency abdominal surgery, the InCare trial. DESIGN: A qualitative study with individual semi-structured interviews. METHODS: We analysed interviews using Systematic Text Condensation. RESULTS: Eighteen patients (nine intervention/nine controls) were strategically sampled from the InCare trial. Data analysis resulted in three distinct descriptions of intermediate care; two of standard surgical ward care. Intermediate care was described as 'luxury service' or 'a life saver.' The latter description was prevalent among patients with a perceived complicated disease course. Intermediate care patients felt constrained by continuous monitoring of vital signs as they recovered from surgery. Standard surgical ward care was described as either 'ok - no more, no less' or 'suboptimal'. Experiencing suboptimal care was related to patient perceptions of heavy staff workloads, lack of staff availability and subsequent concerns about the quality of care. CONCLUSION: Postoperative intermediate care enhanced perceptions of quality of care, specifically in patients with a perceived complicated disease course. Patients were eager to contribute actively to their recovery; however, intermediate care patients felt hindered in doing so by continuous monitoring of vital signs. RELEVANCE TO CLINICAL PRACTICE: Intermediate care may increase patient perceptions of quality and safety of care.

Perspectives and wishes for patient and family centred care as expressed by adult intensive care survivors and family-members: A qualitative interview study.

OBJECTIVES: To explore perspectives and wishes for patient and family centred care among adult patients and family-members with recent experience of admission to an adult intensive care unit. RESEARCH DESIGN: An explorative descriptive study using an inductive thematic analysis. Semi-structured interviews with adults (≥18 years) who had experienced admission ≥48 hours to an adult intensive care unit as a patient or family-member within the previous three months. Interview data were analysed used the six phases of thematic analysis, described by Braun and Clarke. Semi-structured interviews with adults (≥18 years) who had experienced admission ≥48 hours to an adult intensive care unit as a patient or family-member within the previous three months. Interview data were analysed used the six phases of thematic analysis, described by Braun and Clarke. SETTING: Participants were recruited from six general (mixed surgical and medical) units in the Capital Region of Denmark. FINDINGS: From fifteen interviews a total of 23 participants (8 patients and 15 family-members) described their perspectives and wishes for patient- and family-centred care. Three main themes were identified: 1) Ongoing dialogue is fundamental. Both scheduled and spontaneous information-sharing is important. 2) Humanizing. High-quality treatment was especially evident for participants when staff maintain a humanized attitude. 3) Equipping family to navigate. We found a range of specific suggestions of attention that may help patients and family-members to navigate during admission. CONCLUSIONS: We found that patients' and family-members' perspectives and wishes for PFCC centred around ongoing dialogue with staff and the importance of humanizing the ICU environment. Patients and family members needed to share and have their knowledge, concerns and perspectives brought forth and acknowledged by staff. Participants emphasized the pivotal role staff have in equipping patients and family-members to cope in the unit and supporting specifically family-members in fulfilling their role as advocates and supporters of the patient.

Effect of Patient and Family Centred Care interventions for adult intensive care unit patients and their families: A systematic review and meta-analysis.

OBJECTIVES: To assess the evidence for the feasibility and effect of patient and familycentred care interventions provided in the intensive care unit, single or multicomponent, versus usual care, for reducing delirium, anxiety, depression and post-traumatic stress disorder in patients and family-members. DESIGN: A systematic review and meta-analysis following the PRISMA guidelines and GRADE approach. A systematic literature search of relevant databases, screening and inclusion of studies, data extraction and assessment of risk of bias according to Cochrane methodology. The study is preregistered on PROSPERO (CRD42020160768). SETTING: Adult intensive care units. RESULTS: Nine randomised controlled trials enrolling a total of 1170 patients and 1226 family-members were included. We found moderate to low certainty evidence indicating no effect of patient and family centred care on delirium, anxiety, depression, post-traumatic stress disorder, in-hospital mortality, intensive care length of stay or family-members' anxiety, depression and post-traumatic stress disorder. No studies looked at the effect of patient and family centred care on pain or cognitive function in patients. Evaluation of feasibility outcomes was scarce. The certainty of the evidence was low to moderate, mainly due to substantial risk of bias in individual studies and imprecision due to few events and small sample size. CONCLUSION: It remains uncertain whether patient and family centred care compared to usual care may reduce delirium in patients and psychological sequelae of intensive care admission in patients and families due to limited evidence of moderate to low certainty. Lack of systematic process evaluation of intervention feasibility as recommended by the Medical Research Council to identify barriers and facilitators of patient and family centred care in the adult intensive care unit context, further limits the conclusions that can be drawn.

[Track and trigger systems in Denmark - small country, great variations].

A track and trigger (TAT) system and mobile emergency team (MET) can aid observation and care for admitted patients in the hospital ward. We have examined the literature and find evidence, though not strong, that the introduction of TAT and MET systems reduce hospital mortality. However, in Denmark, many different TAT systems are used, and several hospitals do not have MET. We believe, that a standardised national TAT system could encourage interregional research and the investigation of system compliance, cost-benefit and impact on intensive care unit admissions.

Induced hypothermia in patients with septic shock and respiratory failure (CASS): a randomised, controlled, open-label trial.

BACKGROUND: Animal models of serious infection suggest that 24 h of induced hypothermia improves circulatory and respiratory function and reduces mortality. We tested the hypothesis that a reduction of core temperature to 32-34°C attenuates organ dysfunction and reduces mortality in ventilator-dependent patients with septic shock. METHODS: In this randomised, controlled, open-label trial, we recruited patients from ten intensive care units (ICUs) in three countries in Europe and North America. Inclusion criteria for patients with severe sepsis or septic shock were a mean arterial pressure of less than 70 mm Hg, mechanical ventilation in an ICU, age at least 50 years, predicted length of stay in the ICU at least 24 h, and recruitment into the study within 6 h of fulfilling inclusion criteria. Exclusion criteria were uncontrolled bleeding, clinically important bleeding disorder, recent open surgery, pregnancy or breastfeeding, or involuntary psychiatric admission. We randomly allocated patients 1:1 (with variable block sizes ranging from four to eight; stratified by predictors of mortality, age, Acute Physiology and Chronic Health Evaluation II score, and study site) to routine thermal management or 24 h of induced hypothermia (target 32-34°C) followed by 48 h of normothermia (36-38°C). The primary endpoint was 30 day all-cause mortality in the modified intention-to-treat population (all randomly allocated patients except those for whom consent was withdrawn or who were discovered to meet an exclusion criterion after randomisation but before receiving the trial intervention). Patients and health-care professionals giving the intervention were not masked to treatment allocation, but assessors of the primary outcome were. This trial is registered with ClinicalTrials.gov, number NCT01455116. FINDINGS: Between Nov 1, 2011, and Nov 4, 2016, we screened 5695 patients. After recruitment of 436 of the planned 560 participants, the trial was terminated for futility (220 [50%] randomly allocated to hypothermia and 216 [50%] to routine thermal management). In the hypothermia group, 96 (44·2%) of 217 died within 30 days versus 77 (35·8%) of 215 in the routine thermal management group (difference 8·4% [95% CI -0·8 to 17·6]; relative risk 1·2 [1·0-1·6]; p=0·07]). INTERPRETATION: Among patients with septic shock and ventilator-dependent respiratory failure, induced hypothermia does not reduce mortality. Induced hypothermia should not be used in patients with septic shock. FUNDING: Trygfonden, Lundbeckfonden, and the Danish National Research Foundation.

Preadmission quality of life can predict mortality in intensive care unit--a prospective cohort study.

PURPOSE: We sought to investigate whether preadmission quality of life could act as a predictor of mortality among patients admitted to the intensive care unit (ICU). MATERIALS AND METHODS: This is a prospective observational study of all patients above the age of 18 years admitted to the ICU with a length of stay longer than 24 hours. Short form 36 (SF-36) and Acute Physiology and Chronic Health Evaluation II (APACHE II) were used. Mortality was assessed during ICU admission, 30, and 90 days hereafter. RESULTS: We included 318 patients. No patients were lost to follow-up. Using the physical component summary of short form 12 (SF-12) as a predictor of ICU mortality, the area under the curve (0.70; confidence interval, 0.62-0.77) was comparable with that of APACHE II (0.74; confidence interval, 0.67-0.82). The difference between SF-12 and SF-36 was nonsignificant. CONCLUSIONS: Preadmission quality of life, assessed by SF-36 and SF-12, is as good at predicting ICU, 30-, and 90-day mortality as APACHE II in patients admitted to the ICU for longer than 24 hours. This indicates that estimated preadmission quality of life, potentially available in the pre-ICU setting, could aid decision making regarding ICU admission and deserves more attention by those caring for critically ill patients.

Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial.

BACKGROUND: Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. METHODS AND DESIGN: The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. DISCUSSION: This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01209663.

Consecutive daily measurements of luminal concentrations of lactate in the rectum in septic shock patients.

In a recent study we found no difference in the concentrations of luminal lactate in the rectum between nonsurvivors and survivors in early septic shock (<24 h). This study was initiated to investigate if there are any changes in the concentrations of luminal lactate in the rectum during the first 3 days of septic shock and possible differences between nonsurvivors and survivors. Methods. We studied 22 patients with septic shock in this observational study. Six to 24 h after the onset of septic shock the concentration of lactate in the rectal lumen was estimated by 4 h equilibrium dialysis (day 1). The rectal dialysis was repeated on day 2 and day 3. Results. The concentration of lactate in the rectal lumen did not change over the 3 days in neither nonsurvivors nor survivors. Rectal luminal and arterial lactate concentrations were not different. Conclusion. There was no change in the concentration of lactate in the rectal lumen over time in patients with septic shock. Also, there was no difference between nonsurvivors and survivors.

[Septic shock in intensive care]. / Septisk shock på intensivafdeling.

INTRODUCTION: Patients in septic shock have a 33-42% 30-day mortality, but characteristics and outcome have not been assessed in Danish intensive care units (ICUs). MATERIAL AND METHODS: This is a cohort study with prospective registration over a 3-month period of all patients suffering from septic shock at six Danish ICUs. We registered admission-, disease- and treatment characteristics during the first day after the diagnosis and 30- and 90-day mortality. RESULTS: A total of 132 patients with a median age of 64 years (range 15-92 years) were included. Patients were primarily admitted from general wards (n = 56), operation- (31) and emergency rooms (25) and other hospitals (19). Most were diagnosed at ICU admittance. Abdominal focus of infection was most frequent (n = 47) followed by pneumonia (45), soft tissue (14), urinary tract (8), other (6) and unknown (11). Most patients were resuscitated with a combination of crystalloids and colloids (98) and noradrenalin (119), and 100 had broad-spectrum antibiotics prior to the diagnosis, while 27 received such medication 120 (2-450) mins. after diagnosis. Mortality at 30 and 90 days was 33 and 41%, respectively - and highest for patients with abdominal infection 42 and 55%, respectively. CONCLUSION: Patients in septic shock in Danish ICUs are admitted from different hospital locations, have abdominal or pulmonary foci, but the treatment is relatively uniform. The mortality is high, but at par with the best results from other countries.

[Capacity in Danish intensive care units. A national survey of capacity, cancellations and transfers of critically ill patients]. / Kapaciteten på danske intensivafdelinger. En national survey af kapacitet, aflysninger og overflytninger af kritisk syge patienter.

INTRODUCTION: A shortage of intensive care beds and fully-booked intensive care units has a range of undesirable consequences for patients and personnel, eg. transfer to other intensive care units, cancellation of operations, tighter visitation criteria and an increase in the work-load. The problem is illustrated in a national survey. MATERIALS AND METHODS: The survey was undertaken in 3 parts and comprised all 50 adult intensive care units in Denmark. Part 1 was a questionnaire encompassing demographic data, the number of open intensive care beds and how often under or over capacity was experienced in the department. Parts 2 and 3 consisted of a daily registry of the capacity and occupancy rate in the intensive care departments for two weeks along with a contemporary registry of the number of admittances, transfers and cancellations of operations. RESULTS: In Denmark only 2% of all somatic beds are intensive care beds. Under capacity, defined as a 100% occupancy rate, was experienced weekly or monthly in 80% of all intensive care units in Denmark. Occupancy rate was high, a medium of 78%, highest in level III intensive care units with an 88% occupancy rate. The numbers for transfers were equivalent to 800-1000 patient transfers per year. The number of cancelled operations was equivalent to 2000 per year. CONCLUSION: This survey documents that there is a problem with the capacity in Danish intensive care units. Establishing more intensive care beds in selected departments, ensuring personnel for the beds already established and establishing intermediate care beds could relieve the shortage of beds.