Lara Y. Afesh

Permissive Underfeeding or Standard Enteral Feeding in Critically Ill Adults

BACKGROUND The appropriate caloric goal for critically ill adults is unclear. We evaluated the effect of restriction of nonprotein calories (permissive underfeeding), as compared with standard enteral feeding, on 90-day mortality among critically ill adults, with maintenance of the full recommended amount of protein in both groups. METHODS At seven centers, we randomly assigned 894 critically ill adults with a medical, surgical, or trauma admission category to permissive underfeeding (40 to 60% of calculated caloric requirements) or standard enteral feeding (70 to 100%) for up to 14 days while maintaining a similar protein intake in the two groups. The primary outcome was 90-day mortality. RESULTS Baseline characteristics were similar in the two groups; 96.8% of the patients were receiving mechanical ventilation. During the intervention period, the permissive-underfeeding group received fewer mean (±SD) calories than did the standard-feeding group (835±297 kcal per day vs. 1299±467 kcal per day, P<0.001; 46±14% vs. 71±22% of caloric requirements, P<0.001). Protein intake was similar in the two groups (57±24 g per day and 59±25 g per day, respectively; P=0.29). The 90-day mortality was similar: 121 of 445 patients (27.2%) in the permissive-underfeeding group and 127 of 440 patients (28.9%) in the standard-feeding group died (relative risk with permissive underfeeding, 0.94; 95% confidence interval [CI], 0.76 to 1.16; P=0.58). No serious adverse events were reported; there were no significant between-group differences with respect to feeding intolerance, diarrhea, infections acquired in the intensive care unit (ICU), or ICU or hospital length of stay. CONCLUSIONS Enteral feeding to deliver a moderate amount of nonprotein calories to critically ill adults was not associated with lower mortality than that associated with planned delivery of a full amount of nonprotein calories. (Funded by the King Abdullah International Medical Research Center; PermiT Current Controlled Trials number, ISRCTN68144998.).

Use of Intermittent Pneumatic Compression and Not Graduated Compression Stockings Is Associated With Lower Incident VTE in Critically Ill Patients: A Multiple Propensity Scores Adjusted Analysis

BACKGROUND A limited amount of data exist regarding the effect of intermittent pneumatic compression (IPC) and graduated compression stockings (GCS) on the incidence of VTE in the ICU setting. The objective of this study was to examine the association of mechanical thromboprophylaxis with IPC or GCS with the risk of VTE and hospital mortality among critically ill medical-surgical patients. METHODS In this prospective cohort study of patients admitted to the ICU of a tertiary-care medical center between July 2006 and January 2008, we used multiple propensity scores adjustment to examine the association of IPC and GCS with VTE. The primary outcome was incident VTE, including DVT and pulmonary embolism. The following data were collected: patient demographics, admission physiologic data, VTE risk factors, pharmacologic thromboprophylaxis, and mechanical thromboprophylaxis. RESULTS Among 798 patients enrolled in the study, incident VTE occurred in 57 (7.1%). The use of IPC was associated with a significantly lower VTE incidence compared with no mechanical thromboprophylaxis (propensity scores adjusted hazard ratio, 0.45; 95% CI, 0.22-0.95; P=.04). GCS were not associated with decreased VTE incidence. No significant interaction was found between the mechanical thromboprophylaxis group and the type of prophylactic heparin used (P=.99), recent trauma (P=.66), or recent surgery (P=.07) on VTE risk. CONCLUSIONS The use of IPC, but not GCS, was associated with a significantly lower VTE risk. This association was consistent regardless of the type of prophylactic heparin used and was not modified by trauma or surgical admission.

Original ResearchPulmonary Vascular DiseaseUse of Intermittent Pneumatic Compression and Not Graduated Compression Stockings Is Associated With Lower Incident VTE in Critically Ill Patients: A Multiple Propensity Scores Adjusted Analysis

BACKGROUND A limited amount of data exist regarding the effect of intermittent pneumatic compression (IPC) and graduated compression stockings (GCS) on the incidence of VTE in the ICU setting. The objective of this study was to examine the association of mechanical thromboprophylaxis with IPC or GCS with the risk of VTE and hospital mortality among critically ill medical-surgical patients. METHODS In this prospective cohort study of patients admitted to the ICU of a tertiary-care medical center between July 2006 and January 2008, we used multiple propensity scores adjustment to examine the association of IPC and GCS with VTE. The primary outcome was incident VTE, including DVT and pulmonary embolism. The following data were collected: patient demographics, admission physiologic data, VTE risk factors, pharmacologic thromboprophylaxis, and mechanical thromboprophylaxis. RESULTS Among 798 patients enrolled in the study, incident VTE occurred in 57 (7.1%). The use of IPC was associated with a significantly lower VTE incidence compared with no mechanical thromboprophylaxis (propensity scores adjusted hazard ratio, 0.45; 95% CI, 0.22-0.95; P=.04). GCS were not associated with decreased VTE incidence. No significant interaction was found between the mechanical thromboprophylaxis group and the type of prophylactic heparin used (P=.99), recent trauma (P=.66), or recent surgery (P=.07) on VTE risk. CONCLUSIONS The use of IPC, but not GCS, was associated with a significantly lower VTE risk. This association was consistent regardless of the type of prophylactic heparin used and was not modified by trauma or surgical admission.

Permissive underfeeding versus target enteral feeding in adult critically ill patients (PermiT Trial): a study protocol of a multicenter randomized controlled trial

BackgroundNutritional support is an essential part of the management of critically ill patients. However, optimal caloric intake has not been systematically evaluated. We aim to compare two strategies of enteral feeding: permissive underfeeding versus target feeding.Method/DesignThis is an international multi-center randomized controlled trial in critically ill medical- surgical adult patients. Using a centralized allocation, 862 patients will be randomized to permissive underfeeding or target feeding. Patients in the permissive group receive 50% (acceptable range is 40% to 60%) of the calculated caloric requirement, while those in the targeted group receive 100% (acceptable range 70% to 100%) of the calculated caloric requirement. The primary outcome is 90-day all-cause mortality. Secondary outcomes include ICU and hospital mortality, 28-day, and 180-day mortality as well as health care-associated infections, organ failure, and length of stay in the ICU and hospital. The trial has 80% power to detect an 8% absolute reduction in 90-day mortality assuming a baseline risk of death of 25% at an alpha level of 0.05.DiscussionPatient recruitment started in November 2009 and is currently active in five centers. The Data Monitoring Committee advised continuation of the trial after the first interim analysis. The study is expected to finish by November 2013.Trial registrationCurrent Controlled Trials ISRCTN68144998

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial

Author details Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, ICU 1425, PO Box 22490, Riyadh 11426, Kingdom of Saudi Arabia. Emergency Medicine and Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia. Alfaisal University, Riyadh, Kingdom of Saudi Arabia. Interdepartmental Division of Critical Care Medicine, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, ON, Canada. Department of Pulmonary and Critical Care Medicine, King Fahad Medical City, Riyadh, Saudi Arabia. King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia. Department of Critical Care Medicine, King Khalid University, Assir Central Hospital, Abha, Kingdom of Saudi Arabia. Medical/Surgical ICU, University of Toronto, Mount Sinai Hospital, Toronto, ON, Canada. Intensive Care Department, King Abdulaziz Hospital, Al Ahsa, Kingdom of Saudi Arabia. Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Kingdom of Saudi Arabia. International Extended Care Centers, Jeddah, Saudi Arabia. Intensive Care Royal North Shore Hospital of Sydney and Sydney Adventist Hospital, The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, NSW, Australia. Intensive Care Department, King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia. King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia. Received: 17 August 2016 Accepted: 17 August 2016

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial

BackgroundThe Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults.Methods/designIn this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is “incident” proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%.DiscussionConsistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data.Trial registrationClinicalTrials.gov, ID: NCT02040103. Registered on 3 November 2013;Current controlled trials, ID: ISRCTN44653506. Registered on 30 October 2013.