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1.
Crit Care ; 27(1): 83, 2023 03 03.
Artículo en Inglés | MEDLINE | ID: mdl-36869382

RESUMEN

BACKGROUND: This study assessed the mobility levels among critically ill patients and the association of early mobility with incident proximal lower-limb deep-vein thrombosis and 90-day mortality. METHODS: This was a post hoc analysis of the multicenter PREVENT trial, which evaluated adjunctive intermittent pneumatic compression in critically ill patients receiving pharmacologic thromboprophylaxis with an expected ICU stay ≥ 72 h and found no effect on the primary outcome of incident proximal lower-limb deep-vein thrombosis. Mobility levels were documented daily up to day 28 in the ICU using a tool with an 8-point ordinal scale. We categorized patients according to mobility levels within the first 3 ICU days into three groups: early mobility level 4-7 (at least active standing), 1-3 (passive transfer from bed to chair or active sitting), and 0 (passive range of motion). We evaluated the association of early mobility and incident lower-limb deep-vein thrombosis and 90-day mortality by Cox proportional models adjusting for randomization and other co-variables. RESULTS: Of 1708 patients, only 85 (5.0%) had early mobility level 4-7 and 356 (20.8%) level 1-3, while 1267 (74.2%) had early mobility level 0. Patients with early mobility levels 4-7 and 1-3 had less illness severity, femoral central venous catheters, and organ support compared to patients with mobility level 0. Incident proximal lower-limb deep-vein thrombosis occurred in 1/85 (1.3%) patients in the early mobility 4-7 group, 7/348 (2.0%) patients in mobility 1-3 group, and 50/1230 (4.1%) patients in mobility 0 group. Compared with early mobility group 0, mobility groups 4-7 and 1-3 were not associated with differences in incident proximal lower-limb deep-vein thrombosis (adjusted hazard ratio [aHR] 1.19, 95% confidence interval [CI] 0.16, 8.90; p = 0.87 and 0.91, 95% CI 0.39, 2.12; p = 0.83, respectively). However, early mobility groups 4-7 and 1-3 had lower 90-day mortality (aHR 0.47, 95% CI 0.22, 1.01; p = 0.052, and 0.43, 95% CI 0.30, 0.62; p < 0.0001, respectively). CONCLUSIONS: Only a small proportion of critically ill patients with an expected ICU stay ≥ 72 h were mobilized early. Early mobility was associated with reduced mortality, but not with different incidence of deep-vein thrombosis. This association does not establish causality, and randomized controlled trials are required to assess whether and to what extent this association is modifiable. TRIAL REGISTRATION: The PREVENT trial is registered at ClinicalTrials.gov, ID: NCT02040103 (registered on 3 November 2013) and Current controlled trials, ID: ISRCTN44653506 (registered on 30 October 2013).


Asunto(s)
Catéteres Venosos Centrales , Tromboembolia Venosa , Humanos , Anticoagulantes , Enfermedad Crítica , Incidencia
2.
N Engl J Med ; 380(14): 1305-1315, 2019 04 04.
Artículo en Inglés | MEDLINE | ID: mdl-30779530

RESUMEN

BACKGROUND: Whether adjunctive intermittent pneumatic compression in critically ill patients receiving pharmacologic thromboprophylaxis would result in a lower incidence of deep-vein thrombosis than pharmacologic thromboprophylaxis alone is uncertain. METHODS: We randomly assigned patients who were considered adults according to the local standards at the participating sites (≥14, ≥16, or ≥18 years of age) within 48 hours after admission to an intensive care unit (ICU) to receive either intermittent pneumatic compression for at least 18 hours each day in addition to pharmacologic thromboprophylaxis with unfractionated or low-molecular-weight heparin (pneumatic compression group) or pharmacologic thromboprophylaxis alone (control group). The primary outcome was incident (i.e., new) proximal lower-limb deep-vein thrombosis, as detected on twice-weekly lower-limb ultrasonography after the third calendar day since randomization until ICU discharge, death, attainment of full mobility, or trial day 28, whichever occurred first. RESULTS: A total of 2003 patients underwent randomization - 991 were assigned to the pneumatic compression group and 1012 to the control group. Intermittent pneumatic compression was applied for a median of 22 hours (interquartile range, 21 to 23) daily for a median of 7 days (interquartile range, 4 to 13). The primary outcome occurred in 37 of 957 patients (3.9%) in the pneumatic compression group and in 41 of 985 patients (4.2%) in the control group (relative risk, 0.93; 95% confidence interval [CI], 0.60 to 1.44; P = 0.74). Venous thromboembolism (pulmonary embolism or any lower-limb deep-vein thrombosis) occurred in 103 of 991 patients (10.4%) in the pneumatic compression group and in 95 of 1012 patients (9.4%) in the control group (relative risk, 1.11; 95% CI, 0.85 to 1.44), and death from any cause at 90 days occurred in 258 of 990 patients (26.1%) and 270 of 1011 patients (26.7%), respectively (relative risk, 0.98; 95% CI, 0.84 to 1.13). CONCLUSIONS: Among critically ill patients who were receiving pharmacologic thromboprophylaxis, adjunctive intermittent pneumatic compression did not result in a significantly lower incidence of proximal lower-limb deep-vein thrombosis than pharmacologic thromboprophylaxis alone. (Funded by King Abdulaziz City for Science and Technology and King Abdullah International Medical Research Center; PREVENT ClinicalTrials.gov number, NCT02040103; Current Controlled Trials number, ISRCTN44653506.).


Asunto(s)
Anticoagulantes/uso terapéutico , Heparina/uso terapéutico , Aparatos de Compresión Neumática Intermitente , Trombosis de la Vena/prevención & control , Adolescente , Adulto , Anticoagulantes/efectos adversos , Terapia Combinada , Femenino , Heparina/efectos adversos , Heparina de Bajo-Peso-Molecular/uso terapéutico , Mortalidad Hospitalaria , Humanos , Incidencia , Unidades de Cuidados Intensivos , Aparatos de Compresión Neumática Intermitente/efectos adversos , Estimación de Kaplan-Meier , Extremidad Inferior/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Ultrasonografía , Tromboembolia Venosa , Trombosis de la Vena/epidemiología
3.
Chest ; 2024 Sep 02.
Artículo en Inglés | MEDLINE | ID: mdl-39232999

RESUMEN

BACKGROUND: The diagnostic performance of the available risk assessment models for VTE in patients who are critically ill receiving pharmacologic thromboprophylaxis is unclear. RESEARCH QUESTION: For patients who are critically ill receiving pharmacologic thromboprophylaxis, do risk assessment models predict who would develop VTE or who could benefit from adjunctive pneumatic compression for thromboprophylaxis? STUDY DESIGN AND METHODS: In this post hoc analysis of the Pneumatic Compression for Preventing VTE (PREVENT) trial, different risk assessment models for VTE (ICU-VTE, Kucher, Intermountain, Caprini, Padua, and International Medical Prevention Registry on VTE [IMPROVE] models) were evaluated. Receiver-operating characteristic curves were constructed, and the sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios were calculated. In addition, subgroup analyses were performed evaluating the effect of adjunctive pneumatic compression vs none on the study primary outcome. RESULTS: Among 2,003 patients receiving pharmacologic thromboprophylaxis, 198 (9.9%) developed VTE. With multivariable logistic regression analysis, the independent predictors of VTE were Acute Physiology and Chronic Health Evaluation II score, prior immobilization, femoral central venous catheter, and invasive mechanical ventilation. All risk assessment models had areas under the curve < 0.60 except for the Caprini model (0.64; 95% CI, 0.60-0.68). The Caprini, Padua, and Intermountain models had high sensitivity (> 85%) but low specificity (< 20%) for predicting VTE, whereas the ICU-VTE, Kucher, and IMPROVE models had low sensitivities (< 15%) but high specificities (> 85%). The positive predictive value was low (< 20%) for all studied cutoff scores, whereas the negative predictive value was mostly > 90%. Using the risk assessment models to stratify patients into high- vs low-risk subgroups, the effect of adjunctive pneumatic compression vs pharmacologic prophylaxis alone did not differ across the subgroups (Pinteraction > .05). INTERPRETATION: The risk assessment models for VTE performed poorly in patients who are critically ill receiving pharmacologic thromboprophylaxis. None of the models identified a subgroup of patients who might benefit from adjunctive pneumatic compression. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT02040103; URL: www. CLINICALTRIALS: gov. ISRCTN44653506.

4.
Sci Rep ; 12(1): 8519, 2022 05 20.
Artículo en Inglés | MEDLINE | ID: mdl-35595804

RESUMEN

There are contradictory data regarding the effect of intermittent pneumatic compression (IPC) on the incidence of deep-vein thrombosis (DVT) and heart failure (HF) decompensation in critically ill patients. This study evaluated the effect of adjunctive use of IPC on the rate of incident DVT and ventilation-free days among critically ill patients with HF. In this pre-specified secondary analysis of the PREVENT trial (N = 2003), we compared the effect of adjunctive IPC added to pharmacologic thromboprophylaxis (IPC group), with pharmacologic thromboprophylaxis alone (control group) in critically ill patients with HF. The presence of HF was determined by the treating teams according to local practices. Patients were stratified according to preserved (≥ 40%) versus reduced (< 40%) left ventricular ejection fraction, and by the New York Heart Association (NYHA) classification. The primary outcome was incident proximal lower-limb DVT, determined with twice weekly venous Doppler ultrasonography. As a co-primary outcome, we evaluated ventilation-free days as a surrogate for clinically important HF decompensation. Among 275 patients with HF, 18 (6.5%) patients had prevalent proximal lower-limb DVT (detected on trial day 1 to 3). Of 257 patients with no prevalent DVT, 11/125 (8.8%) patients in the IPC group developed incident proximal lower-limb DVT compared to 6/132 (4.5%) patients in the control group (relative risk, 1.94; 95% confidence interval, 0.74-5.08, p = 0.17). There was no significant difference in ventilator-free days between the IPC and control groups (median 21 days versus 25 days respectively, p = 0.17). The incidence of DVT with IPC versus control was not different across NYHA classes (p value for interaction = 0.18), nor across patients with reduced and preserved ejection fraction (p value for interaction = 0.15). Ventilator-free days with IPC versus control were also not different across NYHA classes nor across patients with reduced or preserved ejection fraction. In conclsuion, the use of adjunctive IPC compared with control was associated with similar rate of incident proximal lower-limb DVT and ventilator-free days in critically ill patients with HF.Trial registration: The PREVENT trial is registered at ClinicalTrials.gov, ID: NCT02040103 (registered on 3 November 2013, https://clinicaltrials.gov/ct2/show/study/NCT02040103 ) and Current controlled trials, ID: ISRCTN44653506 (registered on 30 October 2013).


Asunto(s)
Insuficiencia Cardíaca , Tromboembolia Venosa , Trombosis de la Vena , Anticoagulantes/uso terapéutico , Enfermedad Crítica/terapia , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/terapia , Humanos , Aparatos de Compresión Neumática Intermitente , Volumen Sistólico , Tromboembolia Venosa/epidemiología , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/prevención & control , Función Ventricular Izquierda
5.
Intensive Care Med ; 46(4): 737-746, 2020 04.
Artículo en Inglés | MEDLINE | ID: mdl-32095845

RESUMEN

PURPOSE: We examined the association between surveillance for deep vein thrombosis (DVT) among medical-surgical critically ill patients by twice-weekly ultrasonography and 90-day all-cause mortality. METHODS: This was a pre-planned sub-study of the Pneumatic Compression for Preventing Venous Thromboembolism (PREVENT) trial (Clinicaltrials.gov: NCT02040103) that compared addition of intermittent pneumatic compression (IPC) to pharmacologic prophylaxis versus pharmacologic prophylaxis alone. The surveillance group included enrolled patients in the trial, while the non-surveillance group included eligible non-enrolled patients. Using logistic regression and Cox proportional hazards models, we examined the association of surveillance with the primary outcome of 90-day mortality. Secondary outcomes were DVT and pulmonary embolism (PE). RESULTS: The surveillance group consisted of 1682 patients and the non-surveillance group included 383 patients. Using Cox proportional hazards model with bootstrapping, surveillance was associated with a decrease in 90-day mortality (adjusted HR 0.75; 95% CI 0.57, 0.98). Surveillance was associated with earlier diagnosis of DVT [(median 4 days (IQR 2, 10) vs. 20 days (IQR 16, 22)] and PE [median 4 days (IQR 2.5, 5) vs. 7.5 days (IQR 6.1, 28.9)]. There was an increase in diagnosis of DVT (adjusted HR 5.49; 95% CI 2.92, 13.02) with no change in frequency in diagnosis of PE (adjusted HR 0.56; 95% CI 0.19, 1.91). CONCLUSIONS: Twice-weekly surveillance ultrasonography was associated with an increase in DVT detection, reduction in diagnostic testing for non-lower limb DVT and PE, earlier diagnosis of DVT and PE, and lower 90-day mortality. TRIAL REGISTRATION: The PREVENT trial is registered at ClinicalTrials.gov, ID: NCT02040103. Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506. Registered on 30 October 2013.


Asunto(s)
Embolia Pulmonar , Tromboembolia Venosa , Trombosis de la Vena , Enfermedad Crítica , Humanos , Ultrasonografía , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/prevención & control
6.
Medicine (Baltimore) ; 97(36): e12258, 2018 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-30200162

RESUMEN

OBJECTIVE: Surveillance ultrasounds in critically ill patients detect many deep venous thrombi (DVTs) that would otherwise go unnoticed. However, the impact of surveillance for DVT on mortality among critically ill patients remains unclear. DESIGN: We are conducting a multicenter, multinational randomized controlled trial that examines the effectiveness of adjunct intermittent pneumatic compression use with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on the incidence of proximal lower extremity DVT in critically ill patients (the PREVENT trial). Enrolled patients undergo twice weekly surveillance ultrasounds of the lower extremities as part of the study procedures. We plan to compare enrolled patients who have surveillance ultrasounds to patients who meet the eligibility criteria but are not enrolled (eligible non-enrolled patients) and only who will have ultrasounds performed at the clinical team's discretion. We hypothesize that twice-weekly ultrasound surveillance for DVT in critically ill patients who are receiving thromboprophylaxis will have more DVTs detected, and consequently, fewer pulmonary emboli and lower all-cause 90-day mortality. DISCUSSION: We developed a detailed a priori plan to guide the analysis of the proposed study and enhance the validity of its results.


Asunto(s)
Enfermedad Crítica , Monitoreo Fisiológico , Ultrasonografía , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Interpretación Estadística de Datos , Fibrinolíticos/uso terapéutico , Humanos , Aparatos de Compresión Neumática Intermitente , Internacionalidad , Extremidad Inferior/diagnóstico por imagen , Selección de Paciente , Resultado del Tratamiento , Trombosis de la Vena/mortalidad
7.
Trials ; 19(1): 182, 2018 Mar 15.
Artículo en Inglés | MEDLINE | ID: mdl-29544550

RESUMEN

BACKGROUND: The 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/DESIGN: In 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%. DISCUSSION: Consistent 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 REGISTRATION: ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.


Asunto(s)
Interpretación Estadística de Datos , Aparatos de Compresión Neumática Intermitente , Ensayos Clínicos Controlados Aleatorios como Asunto , Tromboembolia Venosa/prevención & control , Humanos , Estudios Multicéntricos como Asunto , Resultado del Tratamiento
8.
Trials ; 17(1): 390, 2016 08 03.
Artículo en Inglés | MEDLINE | ID: mdl-27488380

RESUMEN

BACKGROUND: Venous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC) devices. The Pneumatic compREssion for preventing VENous Thromboembolism (PREVENT trial) aims to determine whether the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis alone in critically ill patients reduces the risk of VTE. METHODS/DESIGN: The PREVENT trial is a multicenter randomized controlled trial, which will recruit 2000 critically ill patients from over 20 hospitals in three countries. The primary outcome is the incidence of proximal lower extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the scans are blinded to intervention allocation, whereas the patients and caregivers are unblinded. The trial has 80 % power to detect a 3 % absolute risk reduction in proximal DVT from 7 to 4 %. DISCUSSION: The first patient was enrolled in July 2014. As of May 2015, a total of 650 patients have been enrolled from 13 centers in Saudi Arabia, Canada and Australia. The first interim analysis is anticipated in July 2016. We expect to complete recruitment by 2018. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02040103 (registered on 3 November 2013). Current controlled trials: ISRCTN44653506 (registered on 30 October 2013).


Asunto(s)
Fibrinolíticos/uso terapéutico , Heparina/uso terapéutico , Aparatos de Compresión Neumática Intermitente , Extremidad Inferior/irrigación sanguínea , Embolia Pulmonar/prevención & control , Tromboembolia Venosa/prevención & control , Trombosis de la Vena/prevención & control , Australia , Canadá , Protocolos Clínicos , Enfermedad Crítica , Fibrinolíticos/efectos adversos , Heparina/efectos adversos , Heparina de Bajo-Peso-Molecular/uso terapéutico , Humanos , Aparatos de Compresión Neumática Intermitente/efectos adversos , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/etiología , Proyectos de Investigación , Factores de Riesgo , Arabia Saudita , Factores de Tiempo , Resultado del Tratamiento , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/etiología , Trombosis de la Vena/diagnóstico , Trombosis de la Vena/etiología
9.
Medicine (Baltimore) ; 94(52): e2339, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26717371

RESUMEN

Admission rate and length of stay (LOS) are two hospital performance indicators that affect the quality of care, patients' satisfaction, bed turnover, and health cost expenditures. The aim of the study was to identify factors associated with higher admission rates and extended average LOS among acutely poisoned children at a single poison center, central Saudi Arabia.This is a cross-sectional, poison and medical chart review between 2009 and 2011. Exposures were child characteristics, that is, gender, age, body mass index (BMI), health history, and Canadian 5-level triage scale. Poison incident characteristics were, that is, type, exposure route, amount, form, home remedy, and arrival time to center. Admission status and LOS were obtained from records. Chronic poisoning, plant allergies, and venomous bites were excluded. Bivariate and regression analyses were applied. Significance at P < 0.05.Of the 315 eligible cases, (72%) were toddlers with equal gender distribution, (58%) had normal BMI, and (77%) were previously healthy. Poison substances were pharmaceutical drugs (63%) versus chemical products (37%). Main exposure route was oral (98%). Home remedy was observed in (21.9%), which were fluids, solutes, and/or gag-induced vomiting. Almost (52%) arrived to center >1 h. Triage levels: non-urgent cases (58%), less urgent (11%), urgent (18%), emergency (12%), resuscitative (1%). Admission rate was (20.6%) whereas av. LOS was 13 ±â€Š22 h. After adjusting and controlling for confounders, older children (adj.OR = 1.19) and more critical triage levels (adj.OR = 1.35) were significantly associated with higher admission rates compared to younger children and less critical triage levels (adj.P = 0.006) and (adj.P = 0.042) respectively. Home remedy prior arrival was significantly associated with higher av. LOS (Beta = 9.48, t = 2.99), compared to those who directly visited the center, adj.P = 0.003.Hospital administrators are cautioned that acutely poisoned children who received home remedies prior arrival are more likely to endure an extended LOS. This non-conventional practice is not recommended.


Asunto(s)
Accidentes Domésticos/estadística & datos numéricos , Servicios Médicos de Urgencia , Servicio de Urgencia en Hospital/estadística & datos numéricos , Intoxicación , Triaje , Adolescente , Niño , Preescolar , Estudios Transversales , Servicios Médicos de Urgencia/métodos , Servicios Médicos de Urgencia/estadística & datos numéricos , Femenino , Sustancias Peligrosas/toxicidad , Humanos , Lactante , Tiempo de Internación/estadística & datos numéricos , Masculino , Preparaciones Farmacéuticas , Intoxicación/diagnóstico , Intoxicación/epidemiología , Intoxicación/etiología , Intoxicación/terapia , Arabia Saudita/epidemiología , Triaje/métodos , Triaje/normas
10.
Chest ; 144(1): 152-159, 2013 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-23412593

RESUMEN

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.


Asunto(s)
Enfermedad Crítica , Pacientes Internos , Aparatos de Compresión Neumática Intermitente , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/prevención & control , Adulto , Anciano , Estudios de Cohortes , Cuidados Críticos , Femenino , Mortalidad Hospitalaria , Humanos , Incidencia , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
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