Closed-Loop Control of Vasopressor Administration in Patients Undergoing Cardiac Revascularization Surgery.
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ABSTRACT:
SUBMITTER: Rinehart J
PROVIDER: S-EPMC7541612 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The central role of pancreas in glucose regulation imposes high demands on perioperative glucose management in patients undergoing pancreatic surgery. In a post hoc subgroup analysis of a randomized controlled trial, we evaluated the perioperative use of subcutaneous (SC) fully closed-loop (FCL; CamAPS HX) versus usual care (UC) insulin therapy in patients undergoing partial or total pancreatic resection. Glucose control was compared using continuous glucose monitoring (CGM) metrics (% time with CGM values between 5.6 and 10.0 mmol/L and more). Over the time of hospitalization, FCL resulted in better glucose control than UC with more time spent in the target range 5.6-10.0 mmol/L (mean [standard deviation] % time in target 77.7% ± 4.6% and 41.1% ± 19.5% in FCL vs. UC subjects, respectively; mean difference 36.6% [95% confidence interval 18.5-54.8]), without increasing the risk of hypoglycemia. Findings suggest that an adaptive SC FCL approach effectively accommodated the highly variable insulin needs in patients undergoing pancreatic surgery. Clinical trials registration: ClinicalTrials.gov, NCT04361799.
| S-EPMC9983122 | biostudies-literature
Project description:Introduction: Vasopressor infusions are essential in treating and preventing intraoperative hypotension. Closed-loop vasopressor therapy outperforms clinicians when the target is set at a mean arterial pressure (MAP) baseline, but little is known on the performance metrics of closed-loop vasopressor infusions when systolic arterial pressure (SAP) is the controlled variable. Methods: Patients undergoing intermediate- to high-risk abdominal surgery were included in this prospective cohort feasibility study. All patients received norepinephrine infusion through a computer controlled closed-loop system that targeted SAP at 130 mmHg. The primary objective was to determine the percent of case time in hypotension or under target defined as SAP below 10% of the target (SAP < 117 mmHg). Secondary objectives were the percent of case time "above target" (SAP > 10% of the target or >143 mmHg) and "in target" (within 10% of the SAP target or SAP between 117 and 143 mmHg). Results: A total of 12 patients were included. The closed-loop system infused norepinephrine for a median of 94.6% (25-75th percentile: 90.0-98.0%) of case time. The percentage of case time in hypotension or under target was only 1.8% (0.9-3.6%). The percentages of case time "above target" and "in target" were 4.7% (3.2-7.5%) and 92.4% (90.1-96.3%), respectively. Conclusions: This closed-loop vasopressor system minimizes intraoperative hypotension and maintains SAP within 10% of the target range for >90% of the case time in patients undergoing intermediate- to high-risk abdominal surgery.
| S-EPMC9604572 | biostudies-literature
Project description:BackgroundVasopressors are a cornerstone for the management of vasodilatory hypotension. Vasopressor infusions are currently adjusted manually to achieve a predefined arterial pressure target. We have developed a closed-loop vasopressor (CLV) controller to help correct hypotension more efficiently during the perioperative period. We tested the hypothesis that patients managed using such a system postcardiac surgery would present less hypotension compared to patients receiving standard management.MethodsA total of 40 patients admitted to the intensive care unit (ICU) after cardiac surgery were randomized into 2 groups for a 2-hour study period. In all patients, the objective was to maintain mean arterial pressure (MAP) between 65 and 75 mm Hg using norepinephrine. In the CLV group, the norepinephrine infusion was controlled via the CLV system; in the control group, it was adjusted manually by the ICU nurse. Fluid administration was standardized in both groups using an assisted fluid management system linked to an advanced hemodynamic monitoring system. The primary outcome was the percentage of time patients were hypotensive, defined as MAP <65 mm Hg, during the study period.ResultsOver the 2-hour study period, the percentage of time with hypotension was significantly lower in the CLV group than that in the control group (1.4% [0.9-2.3] vs 12.5% [9.9-24.3]; location difference, -9.8% [95% CI, -5.4 to -15.9]; P < .001). The percentage of time with MAP between 65 and 75 mm Hg was also greater in the CLV group (95% [89-96] vs 66% [59-77]; location difference, 27.6% [95% CI, 34.3-19.0]; P < .001). The percentage of time with an MAP >75 mm Hg (and norepinephrine still being infused) was also significantly lower in patients in the CLV group than that in the control group (3.2% [1.9-5.4] vs 20.6% [8.9-32.5]; location difference, -17% [95% CI, -10 to -24]; P < .001).The number of norepinephrine infusion rate modifications over the study period was greater in the CLV group than that in the control group (581 [548-597] vs 13 [11-14]; location difference, 568 [578-538]; P < .001). No adverse event occurred during the study period in both groups.ConclusionsClosed-loop control of norepinephrine infusion significantly decreases postoperative hypotension compared to manual control in patients admitted to the ICU after cardiac surgery.
| S-EPMC9808983 | biostudies-literature
Project description:BACKGROUND:Vasopressor agents are used to prevent intraoperative hypotension and ensure adequate perfusion. Vasopressors are usually administered as intermittent boluses or manually adjusted infusions, but this practice requires considerable time and attention. We have developed a closed-loop vasopressor (CLV) controller to correct hypotension more efficiently. Here, we conducted a proof-of-concept study to assess the feasibility and performance of CLV control in surgical patients. METHODS:Twenty patients scheduled for elective surgical procedures were included in this study. The goal of the CLV system was to maintain MAP within 5 mm Hg of the target MAP by automatically adjusting the rate of a norepinephrine infusion using MAP values recorded continuously from an arterial catheter. The primary outcome was the percentage of time that patients were hypotensive, as defined by a MAP of 5 mm Hg below the chosen target. Secondary outcomes included the total dose of norepinephrine, percentage of time with hypertension (MAP>5 mm Hg of the chosen target), raw percentage "time in target" and Varvel performance criteria. RESULTS:The 20 subjects (median age: 64 years [52-71]; male (35%)) underwent elective surgery lasting 154 min [124-233]. CLV control maintained MAP within ±5 mm Hg of the target for 91.6% (85.6-93.3) of the intraoperative period. Subjects were hypotensive for 2.6% of the intraoperative period (range, 0-8.4%). Additional performance criteria for the controller included mean absolute performance error of 2.9 (0.8) and mean predictive error of 0.5 (1.0). No subjects experienced major complications. CONCLUSIONS:In this proof of concept study, CLV control minimised perioperative hypotension in subjects undergoing moderate- or high-risk surgery. Further studies to demonstrate efficacy are warranted. TRIAL REGISTRY NUMBER:NCT03515161 (ClinicalTrials.gov).
| S-EPMC6972231 | biostudies-literature
Project description:BackgroundBone marrow stromal or stem cells (BMSCs) remain a promising potential therapy for ischemic cardiomyopathy. The primary objective of this study was to evaluate the safety and feasibility of direct intramyocardial injection of autologous BMSCs in patients undergoing transmyocardial revascularization (TMR) or coronary artery bypass graft surgery (CABG).MethodsA phase I trial was conducted on adult patients who had ischemic heart disease with depressed left ventricular ejection fraction and who were scheduled to undergo TMR or CABG. Autologous BMSCs were expanded for 3 weeks before the scheduled surgery. After completion of surgical revascularization, BMSCs were directly injected into ischemic myocardium. Safety and feasibility of therapy were assessed. Cardiac functional status and changes in quality of life were evaluated at 1 year.ResultsA total of 14 patients underwent simultaneous BMSC and surgical revascularization therapy (TMR+BMSCs = 10; CABG+BMSCs = 4). BMSCs were successfully expanded, and no significant complications occurred as a result of the procedure. Regional contractility in the cell-treated areas demonstrated improvement at 12 months compared with baseline (TMR+BMSCs Δ strain: -4.6% ± 2.1%; P = .02; CABG+MSCs Δ strain: -4.2% ± 6.0%; P = .30). Quality of life was enhanced, with substantial reduction in angina scores at 1 year after treatment (TMR+BMSCs: 1.3 ± 1.2; CABG+MSCs: 1.0 ± 1.4).ConclusionsIn this phase I trial, direct intramyocardial injection of autologous BMSCs in conjunction with TMR or CABG was technically feasible and could be performed safely. Preliminary results demonstrate improved cardiac function and quality of life in patients at 1 year after treatment.
| S-EPMC8045460 | biostudies-literature
Project description:Hyperglycemia is common in patients undergoing cardiac surgery and is associated with poor outcomes. This is a review of the perioperative insulin protocol being used at Medanta, the Medicity, which has a large volume cardiac surgery setup. Preoperatively, patients are usually continued on their preoperative outpatient medications. Intravenous insulin infusion is intiated postoperatively and titrated using a column method with a choice of 7 scales. Insulin dose is calculated as a factor of blood glucose and patient's estimated insulin sensitivity. A comparison of this protocol is presented with other commonly used protocols. Since arterial blood gas analysis is done every 4 hours for first two days after cardiac surgery, automatic data collection from blood gas analyzer to a central database enables collection of glucose data and generating glucometrics. Data auditing has helped in improving performance through protocol modification.
| S-EPMC4138898 | biostudies-other
Project description:BackgroundHypotension occurs frequently during surgery and may be associated with adverse complications. Vasopressor titration is frequently used to correct hypotension, but requires considerable time and attention, potentially reducing the time available for other clinical duties. To overcome this issue, we have developed a closed-loop vasopressor (CLV) controller to help correct hypotension more efficiently. The aim of this randomised controlled study was to evaluate whether the CLV controller was superior to traditional vasopressor management at minimising hypotension in patients undergoing abdominal surgery.MethodsThirty patients scheduled for elective intermediate-to high-risk abdominal surgery were randomised into two groups. In the CLV group, hypotension was corrected automatically via the CLV controller system, which adjusted the rate of a norepinephrine infusion according to MAP values recorded using an advanced haemodynamic device. In the control group, management of hypotension consisted of standard, manual adjustment of the norepinephrine infusion. The primary outcome was the percentage of time that a patient was hypotensive, defined as MAP <90% of their baseline value, during surgery.ResultsThe percentage of time patients were hypotensive during surgery was 10 times less in the CVL group than in the control group (1.6 [0.9-2.3]% vs 15.4 [9.9-24.3]%; difference: 13 [95% confidence interval: 9-19]; P<0.0001). The CVL group also spent much less time with MAP <65 mm Hg (0.2 [0.0-0.4]% vs 4.5 [1.1-7.9]%; P<0.0001).ConclusionsIn patients undergoing intermediate- to high-risk surgery under general anaesthesia, computer-assisted adjustment of norepinephrine infusion significantly decreases the incidence of hypotension compared with manual control.Clinical trial registrationNCT04089644.
| S-EPMC8489152 | biostudies-literature
Project description:Background: Previous studies have suggested that dexmedetomidine may have a protective effect on renal function. However, it is currently unclear whether perioperative dexmedetomidine administration is associated with postoperative acute kidney injury (AKI) incidence risk in hypertensive patients undergoing non-cardiac surgery. Methods: This investigation was a retrospective cohort study. Hypertensive patients undergoing non-cardiac surgery in Third Xiangya Hospital of Central South University from June 2018 to December 2019 were included. The relevant data were extracted through electronic cases. The univariable analysis identified demographic, preoperative laboratory, and intraoperative factors associated with acute kidney injury. Multivariable stepwise logistic regression was used to assess the association between perioperative dexmedetomidine administration and postoperative acute kidney injury after adjusting for interference factors. In addition, we further performed sensitivity analyses in four subgroups to further validate the robustness of the results. Results: A total of 5769 patients were included in this study, with a 7.66% incidence of postoperative acute kidney injury. The incidence of postoperative acute kidney injury was lower in the dexmedetomidine-administered group than in the control group (4.12% vs. 8.06%, p < 0.001). In the multivariable stepwise logistic regression analysis, perioperative dexmedetomidine administration significantly reduced the risk of postoperative acute kidney injury after adjusting for interference factors [odds ratio (OR) = 0.56, 95% confidence interval (CI): 0.36-0.87, p = 0.010]. In addition, sensitivity analysis in four subgroups indicated parallel findings: i) eGRF <90 mL/min·1.73/m2 subgroup (OR = 0.40, 95% CI: 0.19-0.84, p = 0.016), ii) intraoperative blood loss <1000 mL subgroup (OR = 0.58, 95% CI: 0.36-0.94, p = 0.025), iii) non-diabetes subgroup (OR = 0.51, 95% CI: 0.29-0.89, p = 0.018), and iv) older subgroup (OR = 0.55, 95% CI: 0.32-0.93, p = 0.027). Conclusion: In conclusion, our study suggests that perioperative dexmedetomidine administration is associated with lower risk and less severity of postoperative acute kidney injury in hypertensive individuals undergoing non-cardiac surgery. Therefore, future large-scale RCT studies are necessary to validate this benefit.
| S-EPMC10090366 | biostudies-literature
Project description:To investigate changes in cardiac transcription profiles caused by off-pump cardiac surgery, we collected myocardial samples, prior and after grafting, from patients undergoing off-pump coronary revascularization surgery. The transcriptional profile of the mRNA in these samples was measured with gene array technology. Changes in transcriptional profiles can be correlated with the stress response of heart to off-pump surgery. Keywords: human, cardiac, OPCAB coronary surgery, gene expression. Myocardial samples were collected, prior and after grafting, from patients undergoing off-pump coronary artery bypass grafting.
2010-07-07 | E-GEOD-12485 | biostudies-arrayexpress
Project description:To investigate changes in cardiac transcription profiles caused by off-pump cardiac surgery, we collected myocardial samples, prior and after grafting, from patients undergoing off-pump coronary revascularization surgery. The transcriptional profile of the mRNA in these samples was measured with gene array technology. Changes in transcriptional profiles can be correlated with the stress response of heart to off-pump surgery. Keywords: human, cardiac, OPCAB coronary surgery, gene expression.
2010-06-22 | GSE12485 | GEO