Dataset Information

Proactive Management of Intraoperative Hypotension Reduces Biomarkers of Organ Injury and Oxidative Stress during Elective Non-Cardiac Surgery: A Pilot Randomized Controlled Trial.

ABSTRACT:

Background

Intraoperative hypotension is associated with increased postoperative morbidity and mortality.

Methods

We randomly assigned patients undergoing major general surgery to early warning system (EWS) and hemodynamic algorithm (intervention group, n = 20) or standard care (n = 20). The primary outcome was the difference in hypotension (defined as mean arterial pressure < 65 mmHg) and as secondary outcome surrogate markers of organ injury and oxidative stress.

Results

The median number of hypotensive episodes was lower in the intervention group (-5.0 (95% CI: -9.0, -0.5); p < 0.001), with lower time spent in hypotension (-12.8 min (95% CI: -38.0, -2.3 min); p = 0.048), correspondent to -4.8% of total surgery time (95% CI: -12.7, 0.01%; p = 0.048).The median time-weighted average of hypotension was 0.12 mmHg (0.35) in the intervention group and 0.37 mmHg (1.11) in the control group, with a median difference of -0.25 mmHg (95% CI: -0.85, -0.01; p = 0.025). Neutrophil Gelatinase-Associated Lipocalin (NGAL) correlated with time-weighted average of hypotension (R = 0.32; p = 0.038) and S100B with number of hypotensive episodes, absolute time of hypotension, relative time of hypotension and time-weighted average of hypotension (p < 0.001 for all). The intervention group showed lower Neuronal Specific Enolase (NSE) and higher reduced glutathione when compared to the control group.

Conclusions

The use of an EWS coupled with a hemodynamic algorithm resulted in reduced intraoperative hypotension, reduced NSE and oxidative stress.

SUBMITTER: Murabito P

PROVIDER: S-EPMC8777609 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceIntraoperative hypotension is associated with increased morbidity and mortality. A machine learning-derived early warning system to predict hypotension shortly before it occurs has been developed and validated.ObjectiveTo test whether the clinical application of the early warning system in combination with a hemodynamic diagnostic guidance and treatment protocol reduces intraoperative hypotension.Design, setting, and participantsPreliminary unblinded randomized clinical trial performed in a tertiary center in Amsterdam, the Netherlands, among adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019. Hypotension was defined as a mean arterial pressure (MAP) below 65 mm Hg for at least 1 minute.InterventionsPatients were randomly assigned to receive either the early warning system (n = 34) or standard care (n = 34), with a goal MAP of at least 65 mm Hg in both groups.Main outcomes and measuresThe primary outcome was time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury. This was calculated as the depth of hypotension below a MAP of 65 mm Hg (in millimeters of mercury) × time spent below a MAP of 65 mm Hg (in minutes) divided by total duration of operation (in minutes).ResultsAmong 68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women). The median length of surgery was 256 minutes (IQR, 213-430 minutes). The median time-weighted average of hypotension was 0.10 mm Hg (IQR, 0.01-0.43 mm Hg) in the intervention group vs 0.44 mm Hg (IQR, 0.23-0.72 mm Hg) in the control group, for a median difference of 0.38 mm Hg (95% CI, 0.14-0.43 mm Hg; P = .001). The median time of hypotension per patient was 8.0 minutes (IQR, 1.33-26.00 minutes) in the intervention group vs 32.7 minutes (IQR, 11.5-59.7 minutes) in the control group, for a median difference of 16.7 minutes (95% CI, 7.7-31.0 minutes; P < .001). In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.Conclusions and relevanceIn this single-center preliminary study of patients undergoing elective noncardiac surgery, the use of a machine learning-derived early warning system compared with standard care resulted in less intraoperative hypotension. Further research with larger study populations in diverse settings is needed to understand the effect on additional patient outcomes and to fully assess safety and generalizability.Trial registrationClinicalTrials.gov Identifier: NCT03376347.

Project description:BackgroundIntraoperative hypotension (IOH) occurs frequently during surgery and may be associated with organ ischemia; however, few multicenter studies report data regarding its associations with adverse postoperative outcomes across varying hemodynamic thresholds. Additionally, no study has evaluated the association between IOH exposure and adverse outcomes among patients by various age groups.MethodsA multicenter retrospective cohort study was conducted between 2008 and 2017 using intraoperative blood pressure data from the US electronic health records database to examine postoperative outcomes. IOH was assessed in 368,222 noncardiac surgical procedures using 5 methods: (a) absolute maximum decrease in mean arterial pressure (MAP) during surgery, (b) time under each absolute threshold, (c) total area under each threshold, (d) time-weighted average MAP under each threshold, and (e) cumulative time under the prespecified relative MAP thresholds. MAP thresholds were defined by absolute limits (≤75, ≤65, ≤55 mm Hg) and by relative limits (20% and 40% lower than baseline). The primary outcome was major adverse cardiac or cerebrovascular events; secondary outcomes were all-cause 30- and 90-day mortality, 30-day acute myocardial injury, and 30-day acute ischemic stroke. Residual confounding was minimized by controlling for observable patient and surgical factors. In addition, we stratified patients into age subgroups (18-40, 41-50, 51-60, 61-70, 71-80, >80) to investigate how the association between hypotension and the likelihood of major adverse cardiac or cerebrovascular events and acute kidney injury differs in these age subgroups.ResultsIOH was common with at least 1 reading of MAP ≤75 mm Hg occurring in 39.5% (145,743) of cases; ≤65 mm Hg in 19.3% (70,938) of cases, and ≤55 mm Hg in 7.5% (27,473) of cases. IOH was significantly associated with the primary outcome for all age groups. For an absolute maximum decrease, the estimated odds of a major adverse cardiac or cerebrovascular events in the 30-day postsurgery was increased by 12% (95% confidence interval [CI], 11-14) for ≤75 mm Hg; 17.0% (95% CI, 15-19) for ≤65 mm Hg; and by 26.0% (95% CI, 22-29) for ≤55 mm Hg.ConclusionsIOH during noncardiac surgery is common and associated with increased 30-day major adverse cardiac or cerebrovascular events. This observation is magnified with increasing hypotension severity. The potentially avoidable nature of the hazard, and the extent of the exposed population, makes hypotension in the operating room a serious public health issue that should not be ignored for any age group.

Project description:BACKGROUND:Mechanisms of postoperative delirium remain poorly understood, limiting development of effective treatments. We tested the hypothesis that intraoperative oxidative damage is associated with delirium and neuronal injury and that disruption of the blood-brain barrier modifies these associations. METHODS:In a prespecified cohort study of 400 cardiac surgery patients enrolled in a clinical trial of atorvastatin to reduce kidney injury and delirium, we measured plasma concentrations of F2-isoprostanes and isofurans using gas chromatography-mass spectrometry to quantify oxidative damage, ubiquitin carboxyl-terminal hydrolase isozyme L1 to quantify neuronal injury, and S100 calcium-binding protein B using enzyme-linked immunosorbent assays to quantify blood-brain barrier disruption before, during, and after surgery. We performed the Confusion Assessment Method for the Intensive Care Unit twice daily to diagnose delirium. We measured the independent associations between intraoperative F2-isoprostanes and isofurans and delirium (primary outcome) and postoperative ubiquitin carboxyl-terminal hydrolase isozyme L1 (secondary outcome), and we assessed if S100 calcium-binding protein B modified these associations. RESULTS:Delirium occurred in 109 of 400 (27.3%) patients for a median (10th, 90th percentile) of 1.0 (0.5, 3.0) days. In the total cohort, plasma ubiquitin carboxyl-terminal hydrolase isozyme L1 concentration was 6.3 ng/ml (2.7, 14.9) at baseline and 12.4 ng/ml (7.9, 31.2) on postoperative day 1. F2-isoprostanes and isofurans increased throughout surgery, and the log-transformed sum of intraoperative F2-isoprostanes and isofurans was independently associated with increased odds of postoperative delirium (odds ratio, 3.70 [95% CI, 1.41 to 9.70]; P = 0.008) and with increased postoperative ubiquitin carboxyl-terminal hydrolase isozyme L1 (ratio of geometric means, 1.42 [1.11 to 1.81]; P = 0.005). The association between increased intraoperative F2-isoprostanes and isofurans and increased postoperative ubiquitin carboxyl-terminal hydrolase isozyme L1 was amplified in patients with elevated S100 calcium-binding protein B (P = 0.049). CONCLUSIONS:Intraoperative oxidative damage was associated with increased postoperative delirium and neuronal injury, and the association between oxidative damage and neuronal injury was stronger among patients with increased blood-brain barrier disruption.

Project description:BackgroundThe principles of enhanced recovery after surgery (ERAS) aim to reduce the physiological stress of surgery which in turn improve clinical and health economic outcomes. There is ample evidence in literature supporting ERAS methodologies in other surgical specialties, but its adoption in spinal surgery, especially in Australia remains in infancy. The aim of this project is to describe the early experience with an evidence-based ERAS pathway for simple spine surgery, a first of its kind in Australia.MethodsAn ERAS protocol was designed using an evidenced-based review of the literature. The authors then conducted a prospective cohort analysis looking at outcome of patients undergoing elective spinal (lumbar and cervical) decompression surgery under ERAS principles by a single surgeon on the Westmead Hospital Campus between March 2021 to May 2023. Primary outcomes were patient length of stay (LOS), patient reported pain and disability scores and complications (including readmissions within 30 days and re-operation within 6 months). Secondary outcomes included predictors of failure for same-day discharge.ResultsA total of 52 patients underwent spinal decompression surgeries under the ERAS protocol. Overall 43 out of 52 patients (83.7%) were successfully discharged on the same day as their surgery. Patient reported outcomes were improved at 6 weeks and 6 months confirming durability of intervention. The rates of complications were similar to literature reported rates for simple lumbar or cervical decompression procedures and there were no readmissions within 30 days or re-operations within 6 months of surgery. Being of non-English speaking background [odds ratio (OR) =6.08, P=0.04] and from home alone (OR =10.25, P=0.03) were predictors of failure of same day discharge in this small cohort.ConclusionsImplementation of ERAS protocols for simple spinal decompression surgeries is feasible and produces durable improved patient outcomes while reducing LOS in hospitals. Patient social factors can be predictive of lack of compliance.

Project description:BackgroundIntraoperative hypotension (IOH) during non-cardiac surgery is common and associated with major adverse kidney, neurological and cardiac events and even death. Given that IOH is a modifiable risk factor for the mitigation of postoperative complications, it is imperative to generate a precise definition for IOH to facilitate strategies for avoiding or treating its occurrence. Moreover, a universal and consensus definition of IOH may also facilitate the application of novel and emerging therapeutic interventions in treating IOH. We conducted a review to systematically record the reported definitions of intraoperative hypotension in adults undergoing non-cardiac surgery under general anaesthesia.MethodsIn accordance with Cochrane guidelines, we searched three online databases (OVID [Medline], Embase and Cochrane Library) for all studies published from 1 January 2000 to 6 September 2020. We evaluated the number of studies that reported the absolute or relative threshold values for defining blood pressure. Secondary aims included evaluation of the threshold values for defining IOH, the methodology for accounting for the severity of hypotension, whether the type of surgical procedure influenced the definition of IOH, and whether a study whose definition of IOH aligned with the Perioperative Quality Initiative-3 workgroup (POQI) consensus statement for defining was more likely to be associated with determining an adverse postoperative outcome.ResultsA total of 318 studies were included in the final qualitative synthesis. Most studies (n = 249; 78.3%) used an absolute threshold to define hypotension; 150 (60.5%) reported SBP, 117 (47.2%) reported MAP, and 12 (4.8%) reported diastolic blood pressure (DBP). 126 (39.6%) used a relative threshold to define hypotension. Of the included studies, 153 (48.1%) did not include any duration variable in their definition of hypotension. Among the selected 318 studies 148 (46.5%) studies defined IOH according to the POQI statement. When studies used a "relative blood pressure change" to define IOH, there was a weaker association in detecting adverse postoperative outcomes compared to studies who reported "absolute blood pressure change" (χ2(2) = 10.508, P = 0.005, Cramér's V = 0.182). When studies used the POQI statement definition of hypotension or defined IOH by values higher than the POQI statement definition there were statistical differences observed between IOH and adverse postoperative outcomes (χ2(1) = 6.581, P = 0.037, Cramér's V = 0.144). When both the duration of IOH or the numbers of hypotensive epochs were evaluated, we observed a significantly stronger relationship between the definition of IOH use the development of adverse postoperative outcomes. (χ2(1) = 4.860, P = 0.027, Cramér's V = 0.124).ConclusionsMost studies defined IOH by absolute or relative changes from baseline values. There are substantial inconsistencies in how IOH was reported. Further, definitions differed across different surgical specialities. Our findings further suggest that IOH should be defined using the absolute values stated in the POQI statement i.e., MAP < 60-70 mmHg or SBP < 100 mmHg. Finally, the number of hypotensive epochs or time-weighted duration of IOH should also be reported.