scholarly journals Absence of Evidence and Evidence of Absence in the FLASH Trial: A Bayesian Reanalysis

2020 ◽  
Author(s):  
Eric-Jan Wagenmakers ◽  
Quentin Frederik Gronau
Keyword(s):  
Logistic Regression ◽  
Postoperative Complications ◽  
Abdominal Surgery ◽  
Primary Outcome ◽  
Kidney Injury ◽  
Composite Outcome ◽  
Significant Difference ◽  
Volume Replacement Therapy ◽  
Patients At Risk ◽  
Bayesian Logistic Regression

The multicenter FLASH trial concluded that “Among patients at risk of postoperative kidney injury undergoing major abdominal surgery, use of HES [hydroxyethyl starch] for volume replacement therapy compared with 0.9% saline resulted in no significant difference in a composite outcome of death or major postoperative complications within 14 days after surgery.” Here we use Bayesian logistic regression to quantify the degree to which the data from the FLASH trial, considered in isolation, undercut the hypothesis that HES improves the primary outcome. The results show that the data from the FLASH trial mainly act to increase the plausibility that HES is ineffective, and decrease the plausibility that HES is helpful. These analysis, easily conducted in JASP (jasp-stats.org) or R (https://CRAN.R-project.org/package=abtest) arguably provide a more detailed perspective that supplements the statement that the results showed “no significant difference”.

scholarly journals Is There a Significant Difference in Acute Kidney Injury Incidence Among Patients Treated with Vancomycin Combined with Cefepime or Meropenem?

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S338-S338
Author(s):  
W Cliff Rutter ◽  
David S Burgess
Keyword(s):  
Logistic Regression ◽  
Calcineurin Inhibitors ◽  
Kidney Injury ◽  
Injury Incidence ◽  
University Of Kentucky ◽  
Multivariable Logistic Regression ◽  
Significant Difference ◽  
End Stage ◽  
Therapeutic Alternatives ◽  
The University

Abstract Background Acute kidney injuries (AKIs) are common among patients receiving concomitant vancomycin (VAN) and piperacillin-tazobactam, especially compared with cefepime (FEP) with vancomycin. It is unknown if there is a significant difference between therapeutic alternatives to piperacillin-tazobactam. We hypothesized that AKI rates would be similar in patients treated with FEP+VAN and meropenem (MEM)+VAN. Methods Demographic and clinical data were abstracted from the University of Kentucky Center for Clinical and Translational Sciences Enterprise Data Trust from 2008 through 2015. Patients were included if they received VAN and FEP or MEM in combination for ≥48 hours. Patients with baseline CKD and creatinine clearance <30 mL/minute were excluded. AKI was defined as meeting any of the Risk, Injury, Failure, Loss, End-stage (RIFLE) criteria. Basic descriptive statistics were performed in addition to bivariable and multivariable logistic regression for AKI. Results In total, 3662 patients were included in this study with 3366 patients receiving FEP+VAN and 296 receiving MEM+VAN. Demographic characteristics were evenly distributed among both groups, with the exception of Charlson comorbidity index (MEM+VAN 4 [2–6] vs. 3 [1–6], P = 0.0002), and exposure to aminoglycosides (MEM+VAN 18.2% vs. 13.2%, P = 0.02) and calcineurin inhibitors (MEM+VAN 6.1% vs. 2.7%, P = 0.002). AKI incidence was similar between group (MEM+VAN 12.8% vs. FEP+VAN 10.8%, P = 0.33). After multivariable logistic regression, there was no significant increase in AKI odds with MEM+VAN compared with FEP+VAN (adjusted odds ratio = 1.02; 95% CI 0.67–1.50). Factors associated with increased AKI odds included: male gender, increased baseline comorbidity, age >80, increased duration of antimicrobial therapy, hypotension, increased baseline renal function, and exposure to aminoglycosides, amphotericin B, non-steroidal anti-inflammatory drugs, loop diuretics, or vasopressors. Conclusion No difference in AKI incidence was found between patients treated with MEM+VAN or FEP+VAN. Other clinical factors, aside from AKI potential, should be considered when choosing between alternatives to piperacillin-tazobactam combined with vancomycin. Disclosures All authors: No reported disclosures.

scholarly journals An analytical observational study on the prognostic implication of postoperative serial serum lactate level for complications and predicting length of intensive therapy unit stay after major abdominal surgery

2021 ◽  
Vol 9 (5) ◽  
pp. 1428
Author(s):  
Moumita Mondal ◽  
Sankari Santra ◽  
Rajat Choudhuri ◽  
Amartya Das
Keyword(s):  
Respiratory Failure ◽  
Postoperative Complications ◽  
Abdominal Surgery ◽  
Intensive Therapy ◽  
Wound Dehiscence ◽  
Serum Lactate ◽  
Serum Lactate Level ◽  
Intensive Therapy Unit ◽  
Significant Difference ◽  
Lactate Levels

Background: Post-operative microcirculatory alteration causes hypoperfusion, tissue hypoxia and organ dysfunction, resulting in significant morbidity and mortality. Increase in serum lactate level in response to tissue hypoxia may serve as a cost effective tool to assess status of all organ dysfunction being sensitive but not organ specific and may help in early prognostication. Aim of this study was to investigate the association of blood lactate levels during the first 24 hours after surgery with postoperative morbidity and mortality, with length of ITU stay and to correlate the lactate values at various time points with different postoperative complications (POC).Methods: 150 patients undergoing elective abdominal surgery were included. Blood lactate (mmol/lit) levels were measured immediately on admission to the Intensive Therapy Unit (ITU) and at 6, 12, and 24 hours of admission. The parameters of clinical outcome included were mortality, shock, Acute kidney injury (AKI), respiratory failure, wound dehiscence and length of ITU stay. Heart Rate, Mean Arterial Pressure, spo2, Temperature and Urine output were also measured.Results: There was statistically significant difference in the lactate levels measured at the above mentioned point of time (0, 6, 12 and 24h) in cases with death and without fatal outcome, with and without respiratory failure, with and without AKI, with and without shock and in cases with and without wound dehiscence (p<0.05). There was a statistically significant difference in urine output, duration of ITU stay and duration of intubation (p<0.05).Conclusions: Increased serum lactate levels were significantly associated with postoperative complications, mortality and length of ITU stay in patients undergoing major elective abdominal surgery.

scholarly journals Effect of Xiangbin Prescription in Gastrointestinal Function After Gynecological Abdominal Surgery: a Randomized Controlled Trial

2021 ◽  
Author(s):  
Yuyan Wu ◽  
Jinxuan Lin ◽  
Haiping Zeng ◽  
Yi Chen ◽  
Zhiqiang Chen ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Abdominal Surgery ◽  
Controlled Trial ◽  
Controlled Study ◽  
Chewing Gum ◽  
Control Group ◽  
Gastrointestinal Function ◽  
Blank Control Group ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background: Recovery of gastrointestinal function after gynecological abdominal surgery is a major clinical problem. An effective intervention to promote the rapid recovery of gastrointestinal function postoperatively is lacking. This randomized trial investigated whether Xiangbin prescription (XBP) was feasible in terms of efficacy and safety on gastrointestinal function recovery in patients after gynecological abdominal surgery. Methods: A randomized controlled study was conducted, in which 190 patients with gynecological abdominal surgery who met the inclusion and exclusion criteria were enrolled. They were assigned randomly to XBP group, chewing gum group or blank control group, and respectively received the following treatments: took the XBP twice a day, chewed a piece of gum for about 15 minutes each 4 hours, or received conventional western basic treatment, starting on postoperative day 1 until defecation. Three groups were compared in terms of primary outcomes including the time of the first defecation and the time of the first flatus and secondary outcomes including the level of Ghrelin (GHRL) and the incidence of postoperative complications. Meanwhile, the safety of this trial was evaluated. Results: There was no statistical difference in baseline characteristics among the three groups. For the time of the first flatus, XBP group (22.33 ± 6.68 h) showed less time compared with the chewing gum group (23.06 ± 7.37 h), while it was shorter than that in the blank control group (25.86 ± 7.93 h) with significant difference (P < 0.05). As for the time of the first defecation, XBP group (38.65 ± 12.96 h) showed shorter time significantly compared with both the chewing gum group (47.29 ± 14.50 h) and the blank control group (54.01 ± 20.32 h) (P < 0.05). For the postoperative GHRL levels, XBP group was higher than that in the chewing gum group with no significant difference and had more significant improvement of the GHRL levels at postoperative day 3 compared with the blank control group (P < 0.05). For postoperative complications, XBP group had lower incidence than the other two groups but with no significant difference. For safety evaluations, no serious adverse events occurred in the three groups. Conclusions: XBP could promote the recovery of gastrointestinal function after gynecological abdominal surgery and it is overall safe. Trial registration: This trial was retrospectively registered by Chinese Clinical Trial Registry with the identifier number, ChiCTR1900026327, at September 30, 2019. http://www.chictr.org.cn/.

The Impact of Anti-Tumor Necrosis Factor Alpha Therapy on Postoperative Complications in Pediatric Crohn's Disease

2019 ◽  
Vol 30 (01) ◽  
pp. 027-032
Author(s):  
Vojtech Dotlacil ◽  
Jiri Bronsky ◽  
Ondrej Hradsky ◽  
Barbora Frybova ◽  
Stepan Coufal ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Postoperative Complications ◽  
Tumor Necrosis Factor ◽  
Crohn's Disease ◽  
Abdominal Surgery ◽  
Tumor Necrosis ◽  
Tnf Α ◽  
Significant Difference ◽  
The Impact ◽  
Necrosis Factor

Abstract Introduction The incidence of Crohn's disease (CD) within the pediatric population is increasing worldwide. Despite a growing number of these patients receiving anti-tumor necrosis factor α therapy (anti-TNF-α), one-third of them still require surgery. There is limited data as to whether anti-TNF-α influences postoperative complications. We evaluated postoperative complications in patients who were or were not exposed to anti-TNF-α therapy in our institutional cohort. Materials and Methods A retrospective review of CD patients who underwent abdominal surgery between September 2013 and September 2018 was performed. The patients were divided into two groups based on whether they were treated with anti-TNF-α within 90 days before surgery. Thirty-day postoperative complications were assessed using Clavien–Dindo classification (D-C); this examination included surgical site infections (SSIs), stoma complications, intra-abdominal septic complications, non-SSIs, bleeding, ileus, readmission rate, and return to the operating room. Mann–Whitney U-test, Fisher's exact test, and multivariate logistic regression analyses were used for statistical analysis. Results Sixty-five patients (41 males) with a median age of 16 years (range: 7–19) at the time of operation were identified. The most common surgery was ileocecal resection in 49 (75%) patients. Forty-three (66.2%) patients were treated with anti-TNF-α preoperatively. Seven patients (11%) experienced postoperative complications. There was no statistically significant difference in postoperative complication in patients who did or did not receive anti-TNF-α before surgery (D-C minor 2.3% vs. 4.6%, p = 1; D-C major 7% vs. 9.1%, p = 1). Conclusion The use of anti-TNF-α in pediatric CD patients within the 90 days prior to their abdominal surgery was not associated with an increased risk of 30-day postoperative complications.

Abstract 2118: A Population-based Comparison of the Cardiovascular Protective Effects of Hydrochlorothiazide and Chlorthalidone

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Jeff Nagge ◽  
David N Juurlink
Keyword(s):  
Confidence Interval ◽  
Lower Risk ◽  
Primary Outcome ◽  
Population Based ◽  
Hazard Ratio ◽  
Protective Effects ◽  
Composite Outcome ◽  
Index Event ◽  
Significant Difference

Background Clinical practice guidelines for the treatment of hypertension recommend a thiazide diuretic as initial therapy for the majority of patients. Most clinicians consider chlorthalidone (CHL) and hydrochlorothiazide (HCTZ), the two most commonly prescribed thiazides, to be interchangeable, despite evidence suggesting these drugs are not equivalent. Methods We constructed a population-based retrospective cohort study by linking the health records of 1.4 million residents of Ontario, Canada aged 66 or older between July 1, 1993 and March 1, 2002. The index event for entry into the cohort was a new prescription for either HCTZ or CHL. The primary outcome was the time from the index event to a composite outcome of acute myocardial infarction (AMI), stroke, or all-cause mortality. Secondary analyses explored each outcome individually. Analysis was done using Cox proportional hazards regression with the HCTZ group as the reference. Results During 218,360 person-years of follow-up in the HCTZ group, there were 10 025 events (death, AMI or stroke), compared to 113 events during 4,214 person-years of follow-up in the CHL group. The unadjusted hazard ratio for the primary outcome was 0.73 (95% confidence interval 0.61 to 0.88), suggesting a substantially lower risk of events during CHL therapy. After adjustment for differences in baseline demographic and clinical characteristics, there was no statistically significant difference between the groups for the primary outcome (adjusted hazard ratio 0.85; 95% confidence interval 0.71 to 1.03). The hazard ratios for each component of the primary composite outcome all trended in the direction of a lower risk of events in users of CHL. Conclusion In a large cohort of older patients treated with thiazide diuretics, the use of CHL was not associated with a statistically significant reduction in the risk of AMI, stroke, or death. However, treatment effects favored CHL for every outcome, raising the hypothesis that CHL is superior to HCTZ. Further research is needed to confirm or refute this hypothesis.

Retrospective comparison of open vs minimally invasive cystotomy in 28 cats using a composite outcome score

2021 ◽  
pp. 1098612X2110664
Author(s):  
Nicole J Buote ◽  
Galina Hayes ◽  
Joseph Bisignano ◽  
Desiree Rosselli
Keyword(s):  
Minimally Invasive ◽  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Composite Outcome ◽  
Open Procedure ◽  
Procedural Cost ◽  
Pain Scores ◽  
Outcome Score ◽  
Retrospective Comparison ◽  
Significant Difference

Objectives The aim of this study was to compare the outcomes of cats undergoing open cystotomy with those undergoing minimally invasive surgery (MIS) for removal of cystic calculi by use of a composite outcome score. Methods Twenty-eight cats were retrospectively enrolled and divided into two groups: open cystotomy (n = 14) and MIS (n = 14). The primary outcome measure was a composite outcome score, including three variables: pain scores ⩾2 at either 6 or 12 h postoperatively; failure to remove all stones as determined by postoperative radiographs; and postoperative complications requiring a visit to the hospital separate from the planned suture removal appointment. Other data collected included signalment, history, other procedures performed during anesthesia, willingness to eat the day after surgery and the financial cost of the procedures. Results There was no significant difference in age, weight, sex or breed between the two groups. The risk of experiencing the composite outcome was 3/14 (21.4%) in the MIS group and 10/14 (71%) in the open procedure group ( P = 0.02). The cats in the open surgery group had 8.3 times greater odds of developing the composite outcome than cats in the MIS group (odds ratio 8.3, 95% confidence interval 1.3–74.4; P = 0.02). In the MIS group, 10/14 cats were eating the day after surgery vs 3/14 in the open procedure group ( P = 0.02). The procedural cost was higher in the MIS group, with a median cost of US$945 (interquartile range [IQR] US$872–1021) vs US$623 (IQR US$595–679) in the open group ( P <0.01). Conclusions and relevance In this study the composite outcome score provided evidence to support the use of MIS techniques in cats with cystic calculi. The composite outcome score should be considered in future veterinary studies as a promising method of assessing clinically relevant outcomes.

scholarly journals Intravenous contrast use and acute kidney injury: a retrospective study of 1,238 inpatients undergoing computed tomography

2021 ◽  
Vol 54 (2) ◽  
pp. 77-82
Author(s):  
Thyago A. Coser ◽  
Juliana S. V. Leitão ◽  
Betina M. Beltrame ◽  
Luciano S. Selistre ◽  
Leandro Tasso
Keyword(s):  
Risk Factors ◽  
Computed Tomography ◽  
Acute Kidney Injury ◽  
Logistic Regression ◽  
Primary Outcome ◽  
Kidney Injury ◽  
Primary Outcome Measure ◽  
Relative Increase ◽  
Contrast Administration ◽  
Intravenous Contrast

Abstract Objective: To determine the incidence of nephropathy induced by intravenous contrast in hospitalized patients undergoing computed tomography (CT). Materials and Methods: This was a retrospective cohort study involving 1,238 patients who underwent CT with or without intravenous administration of a contrast agent (iopromide). The primary outcome measure was acute kidney injury (AKI), as defined by the traditional criteria-an absolute or relative increase in serum creatinine (SCr) ≥ 0.5 mg/dL or ≥ 25% over baseline, respectively, at 2-3 days after contrast administration-and the newer, Kidney Disease: Improving Global Outcomes (KDIGO) criteria-an absolute or relative increase in SCr ≥ 0.3 mg/dL or ≥ 50% over baseline, respectively, at 2-7 days after contrast administration. Results: The overall incidence of AKI was 11.52% when the KDIGO criteria were applied. Univariate logistic regression demonstrated a significant association between an absolute post-CT increase in SCr ≥ 0.5 mg/dL and AKI, although that association did not retain significance in the multivariate analysis. Multivariate logistic regression initially found an association between an absolute post-CT increase in SCr ≥ 0.3 mg/dL and advanced age, although that association was not maintained after correction. We found no association between AKI and the risk factors evaluated. Conclusion: We identified no criteria for contrast-induced nephropathy after CT; nor did we find AKI to be associated with the classical risk factors.

Kidney and Mortality Outcomes Associated with Ondansetron in Critically Ill Patients

2022 ◽  
pp. 088506662110735
Author(s):  
Matthew Gray ◽  
Priyanka Priyanka ◽  
Sandra Kane-Gill ◽  
Lirong Wang ◽  
John A. Kellum
Keyword(s):  
Acute Kidney Injury ◽  
Logistic Regression ◽  
Critical Care ◽  
Intensive Care ◽  
Kidney Disease ◽  
Primary Outcome ◽  
Kidney Injury ◽  
Multivariate Logistic Regression ◽  
Increased Risk ◽  
Secondary Outcomes

Background: Ondansetron is a preferred anti-emetic in critical care to treat nausea and vomiting, and has historically been considered a largely safe option. A recent pharmacoepidemiology study reported that ondansetron may be associated with an increased risk for acute kidney injury (AKI). Methods: We interrogated the High-Density Intensive Care (HiDenIC-15) database containing intensive care data for 13 hospitals across Western Pennsylvania between Oct 2008-Dec 2014. AKI was defined using the Kidney Disease, Improving Global Outcomes 2012 guidelines. Ondansetron use was considered as receiving any form of ondansetron within 24 h of admission. The subsequent 48 h (hours 25-72 after admission) were analyzed for outcomes. Primary outcome was development of AKI; secondary outcomes included 90-day mortality and time to AKI. Propensity-matched, multivariate logistic regression was applied for both outcomes. Comparator groups were metoclopramide and prochlorperazine using the same exposure criteria. Results:AKI occurred in 965 (5.6%), 12 (3.0%), and 61 (6.5%) patients receiving ondansetron, prochlorperazine, and metoclopramide, respectively. In the adjusted analysis, no anti-emetic was associated with a significant change in the odds of developing AKI. Ondansetron was associated with a 5.48% decrease (CI −6.17–−4.79) in death within 90 days of ICU-admission, which was independent of AKI status; an effect not seen with other anti-emetics. Anti-emetic usage was not associated with a change in the time to first AKI. Conclusion:Anti-emetic usage did not alter AKI risk. Ondansetron was associated with a significant decrease in 90-day mortality that was not seen by other anti-emetics, which requires further exploration.

scholarly journals 681 Sleep Apnea Severity and COVID-19 Hospitalization Outcomes: Interim Analysis

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A266-A266
Author(s):  
Wissam Mansour ◽  
Melissa Knauert
Keyword(s):  
Risk Factors ◽  
Logistic Regression ◽  
Sleep Apnea ◽  
Critical Illness ◽  
Mortality Rate ◽  
Interim Analysis ◽  
Composite Outcome ◽  
Mild Disease ◽  
Significant Difference ◽  
The Impact

Abstract Introduction Millions worldwide have been infected with COVID-19. Risk factors for poor outcomes include older age, obesity, cardiovascular disease, diabetes, COPD, and minority ethnicity. The impact of sleep apnea (OSA) on COVID-19 illness remains a topic of ongoing research. The association seems plausible as OSA shares common risk factors with COVID-19 comorbidities. The aim of our study is to investigate if the severity of OSA correlates with COVID-19 hospitalization outcomes. Methods The study is an observational retrospective electronic medical chart review of patients admitted to the Yale Health system for COVID-19 illness, who have an ICD medical history diagnosis of sleep apnea. Subjects with an available sleep study were grouped based on AHI severity. Composite outcome was determined by mortality or critical illness (ICU admission, mechanical ventilation, High-Flow nasal cannula or noninvasive ventilation). Interim analysis was conducted with data from 256 patients. Logistic regression was performed to calculate OR associated with the primary outcome comparing mild versus moderate-severe OSA groups. Results The sample of 256 patients included 50% females, with a median age of 64 (IQR,55–73) and BMI of 36 (IQR,30–41). Race distribution composed of 45% Whites and 40% African-Americans with 18% identifying as Hispanic. Overall mortality rate was 16%. Median length of stay (LOS) was 9 days (IQR,5 -15). 155 patients had a recorded AHI with a median of 26/hour (IQR,11–51) grouped into mild (34%), moderate (20%) and severe (45%) disease. Severe sleep apnea had the highest mortality rate of 19% and median LOS of 10 days (IQR,5- 16) compared to moderate (6% mortality,9 days (IQR,6–14)) and mild (17% mortality,6 days (IQR,4–11)) disease; differences were not statistically significant. Univariate logistic regression analysis demonstrated no significant difference in the composite outcome for mild versus moderate-severe OSA groups (OR=1.2; 95% CI:0.58–2.32). Conclusion Severe OSA appeared to have a trend towards an association with higher mortality versus moderate but not mild disease. Comparing moderate-severe disease to a reference group of mild disease did not demonstrate a significant difference in our composite outcome of death or critical illness. Additional subject recruitment and re-analysis are needed to confirm the findings of this interim analysis. Support (if any) N/A

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