A systematic review and meta-analysis of the clinimetric properties of the core outcome measurement instruments for clinical effectiveness trials of nutritional and metabolic interventions in critical illness (CONCISE).

BACKGROUND: CONCISE is an internationally agreed minimum set of outcomes for use in nutritional and metabolic clinical research in critically ill adults. Clinicians and researchers need to be aware of the clinimetric properties of these instruments and understand any limitations to ensure valid and reliable research. This systematic review and meta-analysis were undertaken to evaluate the clinimetric properties of the measurement instruments identified in CONCISE. METHODS: Four electronic databases were searched from inception to December 2022 (MEDLINE via Ovid, EMBASE via Ovid, CINAHL via Healthcare Databases Advanced Search, CENTRAL via Cochrane). Studies were included if they examined at least one clinimetric property of a CONCISE measurement instrument or recognised variation in adults ≥ 18 years with critical illness or recovering from critical illness in any language. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for systematic reviews of Patient-Reported Outcome Measures was used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were used in line with COSMIN guidance. The COSMIN checklist was used to evaluate the risk of bias and the quality of clinimetric properties. Overall certainty of the evidence was rated using a modified Grading of Recommendations, Assessment, Development and Evaluation approach. Narrative synthesis was performed and where possible, meta-analysis was conducted. RESULTS: A total of 4316 studies were screened. Forty-seven were included in the review, reporting data for 12308 participants. The Short Form-36 Questionnaire (Physical Component Score and Physical Functioning), sit-to-stand test, 6-m walk test and Barthel Index had the strongest clinimetric properties and certainty of evidence. The Short Physical Performance Battery, Katz Index and handgrip strength had less favourable results. There was limited data for Lawson Instrumental Activities of Daily Living and the Global Leadership Initiative on Malnutrition criteria. The risk of bias ranged from inadequate to very good. The certainty of the evidence ranged from very low to high. CONCLUSIONS: Variable evidence exists to support the clinimetric properties of the CONCISE measurement instruments. We suggest using this review alongside CONCISE to guide outcome selection for future trials of nutrition and metabolic interventions in critical illness. TRIAL REGISTRATION: PROSPERO (CRD42023438187). Registered 21/06/2023.

Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE).

BACKGROUND: Clinical research on nutritional and metabolic interventions in critically ill patients is heterogenous regarding time points, outcomes and measurement instruments used, impeding intervention development and data syntheses, and ultimately worsening clinical outcomes. We aimed to identify and develop a set of core outcome domains and associated measurement instruments to include in all research in critically ill patients. METHODS: An updated systematic review informed a two-stage modified Delphi consensus process (domains followed by instruments). Measurement instruments for domains considered 'essential' were taken through the second stage of the Delphi and a subsequent consensus meeting. RESULTS: In total, 213 participants (41 patients/caregivers, 50 clinical researchers and 122 healthcare professionals) from 24 countries contributed. Consensus was reached on time points (30 and 90 days post-randomisation). Three domains were considered 'essential' at 30 days (survival, physical function and Infection) and five at 90 days (survival, physical function, activities of daily living, nutritional status and muscle/nerve function). Core 'essential' measurement instruments reached consensus for survival and activities of daily living, and 'recommended' measurement instruments for physical function, nutritional status and muscle/nerve function. No consensus was reached for a measurement instrument for Infection. Four further domains met criteria for 'recommended,' but not 'essential,' to measure at 30 days post-randomisation (organ dysfunction, muscle/nerve function, nutritional status and wound healing) and three at 90 days (frailty, body composition and organ dysfunction). CONCLUSION: The CONCISE core outcome set is an internationally agreed minimum set of outcomes for use at 30 and 90 days post-randomisation, in nutritional and metabolic clinical research in critically ill adults.

Risk factors for intra-abdominal hypertension in mechanically ventilated patients.

BACKGROUND: Intra-abdominal hypertension (IAH) in intensive care patients is associated with an adverse outcome, but the risk factors for development of IAH have not been extensively studied. We aimed to identify independent risk factors for IAH in mechanically ventilated (MV) patients. METHODS: In this prospective observational study, 563 MV patients staying in the general intensive care unit (ICU) of a university hospital for more than 24 h were observed during their ICU stay. Repeated intermittent measurements of intra-abdominal pressure (IAP) via the urinary bladder were performed. RESULTS: IAH (sustained or repeated IAP≥12 mmHg) developed in 182 patients (32.3%). From all the study patients, 44.4% had a primary pathology in the abdomino-pelvic region. Two thirds of all IAH cases developed in this group. Obesity [body mass index (BMI)>30], high positive end-expiratory pressure (PEEP>10), respiratory failure (PaO(2)/FiO(2) <300), use of vasopressors/inotropes, pancreatitis, hepatic failure/cirrhosis with ascites, gastrointestinal bleeding and laparotomy on admission day were identified as independent risk factors for IAH. None of the patients without any of these risk factors (26 patients) developed IAH. CONCLUSION: The precise prediction of development IAH in mixed ICU population remains difficult. In the absence of BMI>30, PEEP>10 cmH(2)O, PaO(2)/FiO(2) <300, use of vasopressors/inotropes, pancreatitis, hepatic failure/cirrhosis with ascites, gastrointestinal bleeding and laparotomy on admission day, the risk for development of IAH in MV ICU patients is minimal.

Prevalence of hypophosphatemia in the ICU - Results of an international one-day point prevalence survey.

BACKGROUND & AIMS: Hypophosphatemia (HypoP) is associated with organ dysfunction and mortality. Despite its potential severe consequences, HypoP remains poorly characterized in terms of real prevalence and timing of onset. The primary objective was to determine the prevalence of HypoP defined as blood phosphate <0.8 and < 0.65 mmol/l on one particular day at international level. METHODS: One-day point prevalence survey conducted by the Section of Metabolism, Endocrinology and Nutrition (MEN) of the European Society of Intensive Care Medicine (ESICM) during week 11-2020. RESULTS: In total, 56 adult and 4 paediatric ICUs, from 22 countries participated: 41 ICUs were mixed medico surgical, the 19 others being cardiac, medical or surgical. Phosphate measurements were performed daily in 21 ICUs, and 1-3 times per week in 39 ICUs. On D-Day 909 patients (883 adults) were present and 668/883 (75.7%) had serum/plasma phosphate determined, revealing a HypoP in 103 (15.4%) patients aged 62 [18 to 85] years. Of those, 49 patients presented phosphate <0.65 mmol/l: cases of hypophosphatemia were detected at any time of patient's ICU stay. No HypoP was observed in children. A treatment protocol existed only in 41.1% of adult ICUs, independently of ICU type, or size. Only 41/98 of the HypoP patients (29/41 of patients with phosphate <0.65 mmol/l) were receiving phosphate. CONCLUSION: HypoP is present at least in 15.4% of ICU patients, and may occur at any time during the ICU stay. The absence of phosphate repletion protocols in 60% of participating ICUs is an unexpected finding, and confirms the necessity for the development of ICU phosphate protocols and guidelines. CLINICALTRIALS IDENTIFIER: NCT04201899.

A Degrading Potassium Tablet Mimicking Active Gastric Bleeding in a Computer Tomographic Investigation.

A 54-year-old male patient was admitted to the hospital due to symptoms caused by an intramural hematoma of the descending aorta. In a contrast media-enhanced computed tomography scan performed five days after admission to evaluate dynamics of the hematoma, a hyperdense lesion was seen in the stomach. A suspicion of gastric hemorrhage was raised at the first evaluation. Because the patient's clinical condition and hemoglobin levels were stable, gastroscopy to rule out an aorto-gastric fistula or another type of bleeding was not undertaken. In the secondary evaluation of the history and images, it became clear that the hyperdense lesion mimicking bleeding in the stomach must have been caused by a degrading potassium tablet ingested by the patient five hours before the investigation.

A systematic review and individual patient data meta-analysis on intra-abdominal hypertension in critically ill patients: the wake-up project. World initiative on Abdominal Hypertension Epidemiology, a Unifying Project (WAKE-Up!).

Intra-abdominal hypertension (IAH), defined as a pathologically increase in intraabdominal pressure, is commonly found in critically ill patients. While IAH has been associated with several abdominal as well as extra-abdominal conditions, few studies have examined the occurrence of IAH in relation to mortality. The aim of this paper was to evaluate the prognostic role of IAH and its risk factors at admission in critically ill patients across a wide range of settings and countries. An individual patient meta-analysis of all available data and a systematic review of published (in full or as abstract) medical databases and studies between 1996 and June 2012 were performed. The search was limited to "clinical trials" and "randomized controlled trials", "adults", using the terms "intra-abdominal pressure", "intraabdominal hypertension" combined with any of the terms "outcome" and "mortality". All together data on 2707 patients, representing 21 centers from 11 countries was obtained. Data on 1038 patients were not analysed because of the following exclusion criteria: no IAP value on admission (N.=712), absence of information on ICU outcome (N.=195), age <18 or >95 years (N.=131). Data from 1669 individual patients (19 centers from 9 countries) were analyzed in the meta-analysis. Presence of IAH was defined as a sustained increase in IAP equal to or above 12 mmHg. At admission the mean overall IAP was 9.9±5.0 mmHg, with 463 patients (27.7%) presenting IAH with a mean IAP of 16.3±3.4 mmHg. The only independent predictors for IAH were SOFA score and fluid balance on the day of admission. Five hundred thirteen patients (30.8%) died in intensive care. The independent predictors for intensive care mortality were IAH, SAPS II score, SOFA score and admission category. This systematic review and individual patient data meta-analysis shows that IAH is frequently present in critically ill patients and it is an independent predictor for mortality.

A Systematic Review And Individual Patient Data Meta-Analysis On Intraabdominal Hypertension In Critically Ill Patients: The Wake-Up Project World Initiative on Abdominal Hypertension Epidemiology, a Unifying Project (WAKE-Up!).

Background: Intraabdominal hypertension (IAH), defined as a pathologically increase in intraabdominal pressure, is commonly found in critically ill patients. While IAH has been associated with several abdominal as well as extra-abdominal conditions, few studies have examined the occurrence of IAH in relation to mortality. Objective: To evaluate the prognostic role of IAH and its risk factors at admission in critically ill patients across a wide range of settings and countries. Data sources: An individual patient meta-analysis of all available data and a systematic review of published (in full or as abstract) medical databases and studies between 1996 and June 2012 were performed. The search was limited to "clinical trials" and "randomized controlled trials", "adults", using the terms "intraabdominal pressure", "intraabdominal hypertension" combined with any of the terms "outcome" and "mortality". All together data on 2707 patients, representing 21 centers from 11 countries was obtained. Data on 1038 patients were not analysed because of the following exclusion criteria: no IAP value on admission (n=712), absence of information on ICU outcome (n=195), age <18 or > 95 years (n=131). Results: Data from 1669 individual patients (19 centers from 9 countries) were analyzed in the meta-analysis. Presence of IAH was defined as a sustained increase in IAP equal to or above 12 mmHg. At admission the mean overall IAP was 9.9±5.0 mmHg, with 463 patients (27.7%) presenting IAH with a mean IAP of 16.3±3.4 mmHg. The only independent predictors for IAH were SOFA score and fluid balance on the day of admission. Five hundred thirteen patients (30.8%) died in intensive care. The independent predictors for intensive care mortality were IAH, SAPS II score, SOFA score and admission category. Conclusions: This systematic review and individual patient data meta-analysis shows that IAH is frequently present in critically ill patients and it is an independent predictor for mortality.

Early enteral nutrition in critically ill patients: ESICM clinical practice guidelines

PURPOSE: To provide evidence-based guidelines for early enteral nutrition (EEN) during critical illness. METHODS: We aimed to compare EEN vs. early parenteral nutrition (PN) and vs. delayed EN. We defined "early" EN as EN started within 48 h independent of type or amount. We listed, a priori, conditions in which EN is often delayed, and performed systematic reviews in 24 such subtopics. If sufficient evidence was available, we performed meta-analyses; if not, we qualitatively summarized the evidence and based our recommendations on expert opinion. We used the GRADE approach for guideline development. The final recommendations were compiled via Delphi rounds. RESULTS: We formulated 17 recommendations favouring initiation of EEN and seven recommendations favouring delaying EN. We performed five meta-analyses: in unselected critically ill patients, and specifically in traumatic brain injury, severe acute pancreatitis, gastrointestinal (GI) surgery and abdominal trauma. EEN reduced infectious complications in unselected critically ill patients, in patients with severe acute pancreatitis, and after GI surgery. We did not detect any evidence of superiority for early PN or delayed EN over EEN. All recommendations are weak because of the low quality of evidence, with several based only on expert opinion. CONCLUSIONS: We suggest using EEN in the majority of critically ill under certain precautions. In the absence of evidence, we suggest delaying EN in critically ill patients with uncontrolled shock, uncontrolled hypoxaemia and acidosis, uncontrolled upper GI bleeding, gastric aspirate >500 ml/6 h, bowel ischaemia, bowel obstruction, abdominal compartment syndrome, and high-output fistula without distal feeding access.

Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome

PURPOSE: To update the World Society of the Abdominal Compartment Syndrome (WSACS) consensus definitions and management statements relating to intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS). METHODS: We conducted systematic or structured reviews to identify relevant studies relating to IAH or ACS. Updated consensus definitions and management statements were then derived using a modified Delphi method and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidelines, respectively. Quality of evidence was graded from high (A) to very low (D) and management statements from strong RECOMMENDATIONS (desirable effects clearly outweigh potential undesirable ones) to weaker SUGGESTIONS (potential risks and benefits of the intervention are less clear). RESULTS: In addition to reviewing the consensus definitions proposed in 2006, the WSACS defined the open abdomen, lateralization of the abdominal musculature, polycompartment syndrome, and abdominal compliance, and proposed an open abdomen classification system. RECOMMENDATIONS included intra-abdominal pressure (IAP) measurement, avoidance of sustained IAH, protocolized IAP monitoring and management, decompressive laparotomy for overt ACS, and negative pressure wound therapy and efforts to achieve same-hospital-stay fascial closure among patients with an open abdomen. SUGGESTIONS included use of medical therapies and percutaneous catheter drainage for treatment of IAH/ACS, considering the association between body position and IAP, attempts to avoid a positive fluid balance after initial patient resuscitation, use of enhanced ratios of plasma to red blood cells and prophylactic open abdominal strategies, and avoidance of routine early biologic mesh use among patients with open abdominal wounds. NO RECOMMENDATIONS were possible regarding monitoring of abdominal perfusion pressure or the use of diuretics, renal replacement therapies, albumin, or acute component-parts separation. CONCLUSION: Although IAH and ACS are common and frequently associated with poor outcomes, the overall quality of evidence available to guide development of RECOMMENDATIONS was generally low. Appropriately designed intervention trials are urgently needed for patients with IAH and ACS.