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Risk factors for and prediction of mortality in critically ill medical-surgical patients receiving heparin thromboprophylaxis.

ABSTRACT: BACKGROUND:Previous studies have suggested that prediction models for mortality should be adjusted for additional risk factors beyond the Acute Physiology and Chronic Health Evaluation (APACHE) score. Our objective was to identify risk factors independent of APACHE II score and construct a prediction model to improve the predictive accuracy for hospital and intensive care unit (ICU) mortality. METHODS:We used data from a multicenter randomized controlled trial (PROTECT, Prophylaxis for Thromboembolism in Critical Care Trial) to build a new prediction model for hospital and ICU mortality. Our primary outcome was all-cause 60-day hospital mortality, and the secondary outcome was all-cause 60-day ICU mortality. RESULTS:We included 3746 critically ill non-trauma medical-surgical patients receiving heparin thromboprophylaxis (43.3 % females) in this study. The new model predicting 60-day hospital mortality incorporated APACHE II score (main effect: hazard ratio (HR) = 0.97 for per-point increase), body mass index (BMI) (main effect: HR = 0.92 for per-point increase), medical admission versus surgical (HR = 1.67), use of inotropes or vasopressors (HR = 1.34), acetylsalicylic acid or clopidogrel (HR = 1.27) and the interaction term between APACHE II score and BMI (HR = 1.002 for per-point increase). This model had a good fit to the data and was well calibrated and internally validated. However, the discriminative ability of the prediction model was unsatisfactory (C index < 0.65). Sensitivity analyses supported the robustness of these findings. Similar results were observed in the new prediction model for 60-day ICU mortality which included APACHE II score, BMI, medical admission and invasive mechanical ventilation. CONCLUSION:Compared with the APACHE II score alone, the new prediction model increases data collection, is more complex but does not substantially improve discriminative ability. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT00182143.

SUBMITTER: Li G

PROVIDER: S-EPMC4769241 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Risk factors for and prediction of mortality in critically ill medical-surgical patients receiving heparin thromboprophylaxis.

Li Guowei G Thabane Lehana L Cook Deborah J DJ Lopes Renato D RD Marshall John C JC Guyatt Gordon G Holbrook Anne A Akhtar-Danesh Noori N Fowler Robert A RA Adhikari Neill K J NKJ Taylor Rob R Arabi Yaseen M YM Chittock Dean D Dodek Peter P Freitag Andreas P AP Walter Stephen D SD Heels-Ansdell Diane D Levine Mitchell A H MAH

Annals of intensive care 20160227 1

<h4>Background</h4>Previous studies have suggested that prediction models for mortality should be adjusted for additional risk factors beyond the Acute Physiology and Chronic Health Evaluation (APACHE) score. Our objective was to identify risk factors independent of APACHE II score and construct a prediction model to improve the predictive accuracy for hospital and intensive care unit (ICU) mortality.<h4>Methods</h4>We used data from a multicenter randomized controlled trial (PROTECT, Prophylaxi ...[more]

PMID: 26921148

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Project description:BackgroundA substantial proportion of critically ill COVID-19 patients develop thromboembolic complications, but it is unclear whether higher doses of thromboprophylaxis are associated with lower mortality rates. The purpose of the study was to evaluate the association between initial dosing strategy of thromboprophylaxis in critically ill COVID-19 patients and the risk of death, thromboembolism, and bleeding.MethodIn this retrospective study, all critically ill COVID-19 patients admitted to two intensive care units in March and April 2020 were eligible. Patients were categorized into three groups according to initial daily dose of thromboprophylaxis: low (2500-4500 IU tinzaparin or 2500-5000 IU dalteparin), medium (> 4500 IU but < 175 IU/kilogram, kg, of body weight tinzaparin or > 5000 IU but < 200 IU/kg of body weight dalteparin), and high dose (≥ 175 IU/kg of body weight tinzaparin or ≥ 200 IU/kg of body weight dalteparin). Thromboprophylaxis dosage was based on local standardized recommendations, not on degree of critical illness or risk of thrombosis. Cox proportional hazards regression was used to estimate hazard ratios with corresponding 95% confidence intervals of death within 28 days from ICU admission. Multivariable models were adjusted for sex, age, body mass index, Simplified Acute Physiology Score III, invasive respiratory support, and initial dosing strategy of thromboprophylaxis.ResultsA total of 152 patients were included: 67 received low-, 48 medium-, and 37 high-dose thromboprophylaxis. Baseline characteristics did not differ between groups. For patients who received high-dose prophylaxis, mortality was lower (13.5%) compared to those who received medium dose (25.0%) or low dose (38.8%), p = 0.02. The hazard ratio of death was 0.33 (95% confidence intervals 0.13-0.87) among those who received high dose, and 0.88 (95% confidence intervals 0.43-1.83) among those who received medium dose, as compared to those who received low-dose thromboprophylaxis. There were fewer thromboembolic events in the high (2.7%) vs medium (18.8%) and low-dose thromboprophylaxis (17.9%) groups, p = 0.04.ConclusionsAmong critically ill COVID-19 patients with respiratory failure, high-dose thromboprophylaxis was associated with a lower risk of death and a lower cumulative incidence of thromboembolic events compared with lower doses.Trial registrationClinicaltrials.gov NCT04412304 June 2, 2020, retrospectively registered.

Project description:Critically ill patients with renal insufficiency are predisposed to both deep vein thrombosis (DVT) and bleeding. The objective of the present study was to evaluate the prevalence, incidence and predictors of DVT and the incidence of bleeding in intensive care unit (ICU) patients with estimated creatinine clearance <30 ml/min.In a multicenter, open-label, prospective cohort study of critically ill patients with severe acute or chronic renal insufficiency or dialysis receiving subcutaneous dalteparin 5,000 IU once daily, we estimated the prevalence of proximal DVT by screening compression venous ultrasound of the lower limbs within 48 hours of ICU admission. DVT incidence was assessed on twice-weekly ultrasound testing. We estimated the incidence of major and minor bleeding by daily clinical assessments. We used Cox proportional hazards regression to identify independent predictors of both DVT and major bleeding.Of 156 patients with a mean (standard deviation) creatinine clearance of 18.9 (6.5) ml/min, 18 had DVT or pulmonary embolism within 48 hours of ICU admission, died or were discharged before ultrasound testing - leaving 138 evaluable patients who received at least one dose of dalteparin. The median duration of dalteparin administration was 7 days (interquartile range, 4 to 12 days). DVT developed in seven patients (5.1%; 95% confidence interval, 2.5 to 10.1). The only independent risk factor for DVT was an elevated baseline Acute Physiology and Chronic Health Evaluation II score (hazard ratio for 10-point increase, 2.25; 95% confidence interval, 1.03 to 4.91). Major bleeding developed in 10 patients (7.2%; 95% confidence interval, 4.0 to 12.8), all with trough anti-activated factor X levels </= 0.18 IU/ml. Independent risk factors for major bleeding were aspirin use (hazard ratio, 6.30; 95% confidence interval, 1.35 to 29.4) and a high International Normalized Ratio (hazard ratio for 0.5-unit increase, 1.68; 95% confidence interval, 1.07 to 2.66).In ICU patients with renal insufficiency, the incidence of DVT and major bleeding are considerable but appear related to patient comorbidities rather than to an inadequate or excessive anticoagulant from thromboprophylaxis with dalteparin.

Project description:Failure to recognize the presence of competing risk or to account for it may result in misleading conclusions. We aimed to perform a competing risk analysis to assess the efficacy of the low molecular weight heparin dalteparin versus unfractionated heparin (UFH) in venous thromboembolism (VTE) in medical-surgical critically ill patients, taking death as a competing risk.This was a secondary analysis of a prospective randomized study of the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT) database. A total of 3746 medical-surgical critically ill patients from 67 intensive care units (ICUs) in 6 countries receiving either subcutaneous UFH 5000 IU twice daily (n?=?1873) or dalteparin 5000 IU once daily plus once-daily placebo (n?=?1873) were included for analysis.A total of 205 incident proximal leg deep vein thromboses (PLDVT) were reported during follow-up, among which 96 were in the dalteparin group and 109 were in the UFH group. No significant treatment effect of dalteparin on PLDVT compared with UFH was observed in either the competing risk analysis or standard survival analysis (also known as cause-specific analysis) using multivariable models adjusted for APACHE II score, history of VTE, need for vasopressors, and end-stage renal disease: sub-hazard ratio (SHR)?=?0.92, 95% confidence interval (CI): 0.70-1.21, P-value?=?0.56 for the competing risk analysis; hazard ratio (HR)?=?0.92, 95% CI: 0.68-1.23, P-value?=?0.57 for cause-specific analysis. Dalteparin was associated with a significant reduction in risk of pulmonary embolism (PE): SHR?=?0.54, 95% CI: 0.31-0.94, P-value?=?0.02 for the competing risk analysis; HR?=?0.51, 95% CI: 0.30-0.88, P-value?=?0.01 for the cause-specific analysis. Two additional sensitivity analyses using the treatment variable as a time-dependent covariate and using as-treated and per-protocol approaches demonstrated similar findings.This competing risk analysis yields no significant treatment effect on PLDVT but a superior effect of dalteparin on PE compared with UFH in medical-surgical critically ill patients. The findings from the competing risk method are in accordance with results from the cause-specific analysis.clinicaltrials.gov Identifier: NCT00182143.

Project description:BACKGROUND:There has been a global increase in the incidence of acute kidney injury (AKI), including among critically-ill surgical patients. AKI prediction score provides an opportunity for early detection of patients who are at risk of AKI; however, most of the AKI prediction scores were derived from cardiothoracic surgery. Therefore, we aimed to develop an AKI prediction score for major non-cardiothoracic surgery patients who were admitted to the intensive care unit (ICU). METHODS:The data of critically-ill patients from non-cardiothoracic operations in the Thai Surgical Intensive Care Unit (THAI-SICU) study were used to develop an AKI prediction score. Independent prognostic factors from regression analysis were included as predictors in the model. The outcome of interest was AKI within 7?days after the ICU admission. The AKI diagnosis was made according to the Kidney Disease Improving Global Outcomes (KDIGO)-2012 serum creatinine criteria. Diagnostic function of the model was determined by area under the Receiver Operating Curve (AuROC). Risk scores were categorized into four risk probability levels: low (0-2.5), moderate (3.0-8.5), high (9.0-11.5), and very high (12.0-16.5) risk. Risk of AKI was presented as likelihood ratios of positive (LH+). RESULTS:A total of 3474 critically-ill surgical patients were included in the model; 333 (9.6%) developed AKI. Using multivariable logistic regression analysis, older age, high Sequential Organ Failure Assessment (SOFA) non-renal score, emergency surgery, large volume of perioperative blood loss, less urine output, and sepsis were identified as independent predictors for AKI. Then AKI prediction score was created from these predictors. The summation of the score was 16.5 and had a discriminative ability for predicting AKI at AuROC?=?0.839 (95% CI 0.825-0.852). LH+ for AKI were: low risk?=?0.117 (0.063-0.200); moderate risk?=?0.927 (0.745-1.148); high risk?=?5.190 (3.881-6.910); and very high risk?=?9.892 (6.230-15.695), respectively. CONCLUSIONS:The function of AKI prediction score to predict AKI among critically ill patients who underwent non-cardiothoracic surgery was good. It can aid in early recognition of critically-ill surgical patients who are at risk from ICU admission. The scores could guide decision making for aggressive strategies to prevent AKI during the perioperative period or at ICU admission. TRIAL REGISTRATION:TCTR20190408004, registered on April 4, 2019.

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Risk factors for and prediction of mortality in critically ill medical-surgical patients receiving heparin thromboprophylaxis.

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Risk factors for and prediction of mortality in critically ill medical-surgical patients receiving heparin thromboprophylaxis.

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