scholarly journals The evolution of mean arterial pressure in critically ill patients on vasopressors before and during a trial comparing a specific mean arterial pressure target to usual care

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Marie-Hélène Masse ◽  
Neill K. J. Adhikari ◽  
Xavier Théroux ◽  
Marie-Claude Battista ◽  
Frédérick D’Aragon ◽  
...  

Abstract Background In randomized clinical controlled trials, the choice of usual care as the comparator may be associated with better clinician uptake of the study protocol and lead to more generalizable results. However, if care processes evolve to resemble the intervention during the course of a trial, differences between the intervention group and usual care control group may narrow. We evaluated the effect on mean arterial pressure of an unblinded trial comparing a lower mean arterial pressure target to reduce vasopressor exposure, vs. a clinician-selected mean arterial pressure target, in critically ill patients at least 65 years old. Methods For this multicenter observational study using data collected both prospectively and retrospectively, patients were recruited from five of the seven trial sites. We compared the mean arterial pressure of patients receiving vasopressors, who met or would have met trial eligibility criteria, from two periods: [1] at least 1 month before the trial started, and [2] during the trial period and randomized to usual care, or not enrolled in the trial. Results We included 200 patients treated before and 229 after trial initiation. There were no differences in age (mean 74.5 vs. 75.2 years; p = 0.28), baseline Acute Physiology and Chronic Health Evaluation II score (median 26 vs. 26; p = 0.47) or history of chronic hypertension (n = 126 [63.0%] vs. n = 153 [66.8%]; p = 0.41). Mean of the mean arterial pressure was similar between the two periods (72.5 vs. 72.4 mmHg; p = 0.76). Conclusions The initiation of a trial of a prescribed lower mean arterial pressure target, compared to a usual clinician-selected target, was not associated with a change in mean arterial pressure, reflecting stability in the net effect of usual clinician practices over time. Comparing prior and concurrent control groups may alleviate concerns regarding drift in usual practices over the course of a trial or permit quantification of any change.

2016 ◽  
Vol 25 (6) ◽  
pp. e108-e119 ◽  
Author(s):  
Peggy Kalowes ◽  
Valerie Messina ◽  
Melanie Li

BackgroundIn critically ill patients, prevention of pressure ulcers is a challenge because of the high risk for multiple comorbid conditions, immobility, hemodynamic instability, and increased use of medical devices.ObjectivesTo compare the difference in incidence rates of hospital-acquired pressure ulcers (HAPUs) in critically ill patients between those treated with usual preventive care and a 5-layered soft silicone foam dressing versus a control group receiving usual care. Secondary goals were to examine risk factors for HAPUs in critically ill patients and to explicate cost savings related to prevention of pressure ulcers.MethodsA prospective, randomized controlled trial in the intensive care units at a 569-bed, level II trauma hospital. All 366 participants received standard pressure ulcer prevention; 184 were randomized to have a 5-layered soft silicone foam dressing applied to the sacrum (intervention group) and 182 to receive usual care (control group).ResultsThe incidence rate of HAPUs was significantly less in patients treated with the foam dressing than in the control group (0.7% vs 5.9%, P = .01). Time to injury survival analysis (Cox proportional hazard models) revealed the intervention group had 88% reduced risk of HAPU development (hazard ratio, 0.12 [95% CI, 0.02–0.98], P = .048).ConclusionUse of a soft silicone foam dressing combined with preventive care yielded a statistically and clinically significant benefit in reducing the incidence rate and severity of HAPUs in intensive care patients. This novel, cost-effective method can reduce HAPU incidence in critically ill patients.


2019 ◽  
Vol 2019 ◽  
pp. 1-5 ◽  
Author(s):  
Ida Royani ◽  
Suryani As’ad ◽  
Nasrudin A Mappaware ◽  
Mochammad Hatta ◽  
Rabia

Background. Preeclampsia is the major problem and the main leading cause of fetal and maternal mortality worldwide. The early prediction of preeclampsia in pregnant women is required to prevent the occurrence of preeclampsia. The mean arterial pressure (MAP) and roll-over test (ROT) are the combination of measurement which can be used to predict preeclampsia. On the contrary, Ajwa dates were reported to have an enormous activity which contributes to its role in improving health conditions. In this study, we aimed to evaluate the effect of daily consumption of seven Ajwa dates on prevention of preeclampsia, through MAP and ROT changes. Methods. Forty pregnant women (n = 40) were randomly assigned into the control group (n = 10) and the intervention group which received a daily intake of Ajwa dates (n = 30). The MAP and ROT were assessed before and after the 8-week intervention period. Results. The intervention group showed the significant reduction in MAP and ROT following the 8-week intervention period (p<0.05). Conclusion. Daily consumption of seven Ajwa dates has a remarkable potential to decrease the MAP and ROT in pregnant women at risk of developing preeclampsia, and thus, it can contribute to prevent the development of preeclampsia.


2021 ◽  
Vol 25 (14) ◽  
pp. 1-90
Author(s):  
Paul R Mouncey ◽  
Alvin Richards-Belle ◽  
Karen Thomas ◽  
David A Harrison ◽  
M Zia Sadique ◽  
...  

Background Vasopressors are administered to critical care patients to avoid hypotension, which is associated with myocardial injury, kidney injury and death. However, they work by causing vasoconstriction, which may reduce blood flow and cause other adverse effects. A mean arterial pressure target typically guides administration. An individual patient data meta-analysis (Lamontagne F, Day AG, Meade MO, Cook DJ, Guyatt GH, Hylands M, et al. Pooled analysis of higher versus lower blood pressure targets for vasopressor therapy septic and vasodilatory shock. Intensive Care Med 2018;44:12–21) suggested that greater exposure, through higher mean arterial pressure targets, may increase risk of death in older patients. Objective To estimate the clinical effectiveness and cost-effectiveness of reduced vasopressor exposure through permissive hypotension (i.e. a lower mean arterial pressure target of 60–65 mmHg) in older critically ill patients. Design A pragmatic, randomised clinical trial with integrated economic evaluation. Setting Sixty-five NHS adult general critical care units. Participants Critically ill patients aged ≥ 65 years receiving vasopressors for vasodilatory hypotension. Interventions Intervention – permissive hypotension (i.e. a mean arterial pressure target of 60–65 mmHg). Control (usual care) – a mean arterial pressure target at the treating clinician’s discretion. Main outcome measures The primary clinical outcome was 90-day all-cause mortality. The primary cost-effectiveness outcome was 90-day incremental net monetary benefit. Secondary outcomes included receipt and duration of advanced respiratory and renal support, mortality at critical care and acute hospital discharge, and questionnaire assessment of cognitive decline and health-related quality of life at 90 days and 1 year. Results Of 2600 patients randomised, 2463 (permissive hypotension, n = 1221; usual care, n = 1242) were analysed for the primary clinical outcome. Permissive hypotension resulted in lower exposure to vasopressors than usual care [mean duration 46.0 vs. 55.9 hours, difference –9.9 hours (95% confidence interval –14.3 to –5.5 hours); total noradrenaline-equivalent dose 31.5 mg vs. 44.3 mg, difference –12.8 mg (95% CI –18.0 mg to –17.6 mg)]. By 90 days, 500 (41.0%) patients in the permissive hypotension group and 544 (43.8%) patients in the usual-care group had died (absolute risk difference –2.85%, 95% confidence interval –6.75% to 1.05%; p = 0.154). Adjustment for prespecified baseline variables resulted in an odds ratio for 90-day mortality of 0.82 (95% confidence interval 0.68 to 0.98) favouring permissive hypotension. There were no significant differences in prespecified secondary outcomes or subgroups; however, patients with chronic hypertension showed a mortality difference favourable to permissive hypotension. At 90 days, permissive hypotension showed similar costs to usual care. However, with higher incremental life-years and quality-adjusted life-years in the permissive hypotension group, the incremental net monetary benefit was positive, but with high statistical uncertainty (£378, 95% confidence interval −£1347 to £2103). Limitations The intervention was unblinded, with risk of bias minimised through central allocation concealment and a primary outcome not subject to observer bias. The control group event rate was higher than anticipated. Conclusions In critically ill patients aged ≥ 65 years receiving vasopressors for vasodilatory hypotension, permissive hypotension did not significantly reduce 90-day mortality compared with usual care. The absolute treatment effect on 90-day mortality, based on 95% confidence intervals, was between a 6.8-percentage reduction and a 1.1-percentage increase in mortality. Future work Future work should (1) update the individual patient data meta-analysis, (2) explore approaches for evaluating heterogeneity of treatment effect and (3) explore 65 trial conduct, including use of deferred consent, to inform future trials. Trial registration Current Controlled Trials ISRCTN10580502. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 14. See the NIHR Journals Library website for further project information.


F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 929
Author(s):  
Nouran Hesham El-Sherazy ◽  
Naglaa Samir Bazan ◽  
Sara Mahmoud Shaheen ◽  
Nagwa A. Sabri

Background Antioxidants show nephroprotective effect against vancomycin associated nephrotoxicity (VAN) in animals. This study aimed to assess the ascorbic acid nephro-protective role against VAN clinically. Methods Forty-one critically ill patients were randomly assigned to one of two groups: intervention group (vancomycin IV plus ascorbic acid, n=21) or control group (vancomycin IV only, n=20). Primary outcomes were the incidence of VAN and the absolute change in creatinine parameters, while mortality rate was the secondary outcome. Nephrotoxicity was defined as an increase in serum creatinine (S.cr) by at least 0.5 mg/dL or 50% of baseline for at least two successive measurements. This study is registered at Clinicaltrials.gov (NCT03921099), April 2019. Results Mean absolute S.cr increase was significant when compared between both groups, P-value = 0.036, where S.cr increased by 0.05(0.12) and 0.34(0.55) mg/dL in the intervention and control groups, respectively. Mean absolute Cr.cl decline was significant when compared between both groups, P-value = 0.04, where Cr.cl was decreased by 5.9(17.8) and 22.3(30.4) ml/min in the intervention and control groups, respectively. Incidence of VAN was 1/21(4.7%) versus 5/20(25%) in the intervention and control groups, respectively (RR: 0.19; CI: 0.024–1.49; P-value = 0.093). Mortality was higher in the control group; however, it was not statistically significant, P-value = 0.141. Conclusion Co-administration of ascorbic acid with vancomycin preserved renal function and reduced the absolute risk of VAN by 20.3%, however, the reduction in VAN incidence didn’t reach statistical significance level. Further large multicenter prospective trials are recommended.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Chrysohoou ◽  
A Angelis ◽  
G Titsinakis ◽  
D Tsiachris ◽  
P Aggelopoulos ◽  
...  

Abstract Background Cardiac power has been suggested as the most power predictor of mortality in heart failure (HF) patients. In those patients aorta elastic properties and compensation is lost, systolic (and pulse) pressure are therefore reduced and associated with a decrease in ejection duration and pump efficiency. Cardiac rehabilitation programs have showed enhancement in cardiac performance and quality of life in HF patients. Aim Aim of this work was to evaluate the effect of high-intensity interval exercise (i.e., 30 sec at 100% of max workload, followed by 30 sec at rest, on a day-by-day 30 minutes working-out schedule for 12 weeks), on cardiac power, diastolic function indices, right ventricle performance and cardiorespiratory parameters among chronic HF patients. Methods 72 consecutive HF patients (NYHA class II-IV, ejection fraction <50%) who completed the study (exercise training group, n=33, 63±9 years, 88% men, and control group, n=39, 56±11 years, 82% men), underwent cardiopulmonary stress test, non-invasive high-fidelity tonometry of the radial artery, pulse wave velocity measurement using a SphygmoCor device, and echocardiography before and after completion of the training program. Cardiac power output (CPO) (W) was calculated as mean arterial pressure × CO/451, where mean arterial pressure = [(systolic blood pressure − diastolic blood pressure)/3] + diastolic blood pressure. Results Both groups reported similar medical characteristics and physical activity status. General mixed effects models revealed that the intervention group increased 6MWT (by 13%, p<0.05); increased cycle ergometry WRpeak (by 25%, p<0.01), showed higher O2max by 31% (p<0.001) and lower VE/VCO2 (p=0.05), whereas patients in the control group showed nosignificant changes in the aforementioned indices. Also, in the intervention group Emv/Vp was decreased by 14% (p=0.06); E to A ratio by 24% (p=0.004) and E to Emv ratio by 8% (p=0.05); while Stv increased by 25% (p=0.01). Most importantly, the intervention group reduced pulse wave velocity by 9% (p=0.05) and increased augmentation index by 26%; and VTI by 4% (p=0.05); Those parameters were not significantly changed on control group (all p>0.05). Conclusion Hight intensity exercise rehabilitation program revealed beneficial effect on left ventricular diastolic indices and right ventricle performance. As, in those patients compensation of the aorta is also lost and the LV cannot generate the extra force necessary to completely overcome the late systolic augmented pressure, the increase in the augmented pressure (AIa) observed in the intervention group reflects the benefit in aorto-ventricular coupling and cardiac power that boosts systolic pressure and restores a positive influence in pressure, like in early stages of HF. Acknowledgement/Funding None


2016 ◽  
Vol 50 (5) ◽  
pp. 823-830 ◽  
Author(s):  
Patrícia de Oliveira Salgado ◽  
Ludmila Christiane Rosa da Silva ◽  
Priscila Marinho Aleixo Silva ◽  
Tânia Couto Machado Chianca

Abstract OBJECTIVE To evaluate the effects of physical methods of reducing body temperature (ice pack and warm compression) in critically ill patients with fever. METHOD A randomized clinical trial involving 102 adult patients with tympanic temperature ≥ 38.3°C of an infectious focus, and randomized into three groups: Intervention I - ice pack associated with antipyretic; Intervention II - warm compress associated with antipyretic; and Control - antipyretic. Tympanic temperature was measured at 15 minute intervals for 3 hours. The effect of the interventions was evaluated through the Mann-Whitney test and Survival Analysis. "Effect size" calculation was carried out. RESULTS Patients in the intervention groups I and II presented greater reduction in body temperature. The group of patients receiving intervention I presented tympanic temperature below 38.3°C at 45 minutes of monitoring, while the value for control group was lower than 38.3°C starting at 60 minutes, and those who received intervention II had values lower than 38.3°C at 75 minutes of monitoring. CONCLUSION No statistically significant difference was found between the interventions, but with the intervention group I patients showed greater reduction in tympanic temperature compared to the other groups. Brazilian Registry of Clinical Trials: RBR-2k3kbq


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.S Sahlin ◽  
S Gerward

Abstract Background A common heart failure (HF) aetiology is hypertension (HTN), second only to ischemic heart disease and with a prevalence in the HF community of between 62% and 84%, depending on sex and ejection-fraction. Undertreated HTN leads to worse prognosis and resistant HTN is defined as blood pressure (BP) exceeding 140/90 mmHg, in spite of pharmacological treatment. Since one constituent of self-care behaviour is treatment adherence, we wished to study whether patients exposed to a digital intervention shown to improve self-care behaviour, would also display improved BP control. Methods SMART-HF was a randomized controlled trial, recruiting patients from seven centres in Region Skåne in southern Sweden, where patients in the intervention group (IG) were equipped with a digital home-based tool, designed to enhance self-care behaviour for HF-patients and the control group (CG) were subject to standard care. BP data was registered at baseline and after eight months of intervention and self-care behaviour was measured using the European Heart Failure Self-care Behaviour Scale (EHFScB). We used a Chi-square test to analyse whether there was an inter-group difference of prevalence of resistant HTN or a mean arterial pressure (MAP) outside the recommended range of 60 mmHg &lt; MAP &lt;100 mmHg. Results Out of the 118 patients included in the original analysis, 92 (78%) had complete BP measurements. At baseline there was no difference in self-care behaviour between the groups, with CG: 25 [17.5; 32] and IG: 24.5 [18; 30], p=0.61, and 28% of the CG patients and 24% of the IG population displayed resistant HTN, p=0.73. After eight months of intervention the IG had 21% (or 4.5 points) better self-care behaviour compared to the CG, p=0.014, and the fraction of patients with resistant HTN was 30% for the CG and 11% for the IG, p=0.027. There was also a significant effect on the fraction of patients having a MAP &gt;100 mmHg, with 22% in the CG versus 16% in the IG having MAP &gt;100 mmHg at baseline (p=0.39) and 19% in the CG versus 0% in the IG at follow-up (p=0.002). Conclusions There was a significant improvement in self-care behaviour and also a significant reduction in the number of patients with resistant hypertension and elevated mean arterial pressure after eight months of intervention. Funding Acknowledgement Type of funding source: None


2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Wesley Henrique Bueno de Camargo ◽  
Rita de Cassia Pereira ◽  
Marcos T. Tanita ◽  
Lidiane Heko ◽  
Isadora C Grion ◽  
...  

Purpose. To analyze whether a viscoelastic mattress support surface can reduce the incidence of stage 2 pressure injuries compared to a standard hospital mattress with pyramidal overlay in critically ill patients. Method. A randomized clinical trial with intention-to-treat analysis was carried out recruiting patients with Braden scale ≤14 on intensive care unit admission from April 2016 to April 2017. Patients were allocated into two groups: intervention group (viscoelastic mattress) and control group (standard mattress with pyramidal overlay). The level of significance adopted was 5%. Results. A total of 62 patients were included in the study. There was a predominance of males (53%) and the mean age was 67.9 (SD 18.8) years. There were no differences in clinical or severity characteristics between the patients in the control group and the intervention group. Pressure injuries occurred in 35 patients, with a median time of 7 days (ITQ 4–10) from admission. The frequency of pressure injuries was higher in the control group (80.6%) compared to the intervention group (32.2%; p<0.001). Conclusions. Viscoelastic support surfaces reduced the incidence of pressure injuries in moderate or higher risk critically ill patients when compared to pyramidal support surfaces.


Author(s):  
Fayza Ahmed Abdou ◽  
Amal Ismael Abd El-Hafez

Background: One of complementary therapy is foot reflexology practice which is effortlessly, un-costly and with little risks or complications and can be considered as part of nursing procedures for acute pain and anxiety after cardiothoracic surgery. Objective: evaluate the effect of foot reflexology practice on acute pain and anxiety of critically ill patients after cardiothoracic surgery. Research hypothesis: The pain and anxiety score among the interventional group who receiving the foot reflexology practice is lower than that of the control group. Research design: a quasi-experimental research design was used. Setting: This study was conducted in Cardiothoracic and Post-Operative Intensive Care Units at Assuit University Hospital. Subjects: sixty patients were enrolled in this study and assigned equally to intervention and control groups during the period of data collection from February 2015 to February 2016. Results: There were significant differences between the mean of pain and anxiety score of both groups at immediately, and 45 minutes indicating lower mean of pain and anxiety level among intervention group who received foot reflexology practice than control group. Conclusion: The intervention group who received foot reflexology practice had lower pain and anxiety level than the control group who didn’t received foot reflexology practice after cardiothoracic surgery.


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