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1.
JAMA Surg ; : e200794, 2020 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-32459322

RESUMO

Importance: Morbidity is still high in pancreatic surgery, driven mainly by gastrointestinal complications such as pancreatic fistula. Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are frequently used for pain control after pancreatic surgery. Evidence from a post hoc analysis suggests that PCIA is associated with fewer gastrointestinal complications. Objective: To determine whether postoperative PCIA decreases the occurrence of gastrointestinal complications after pancreatic surgery compared with EDA. Design, Setting, and Participants: In this adaptive, pragmatic, international, multicenter, superiority randomized clinical trial conducted from June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy were randomized to receive PCIA (n = 185) or EDA (n = 186); 248 patients (124 in each group) were analyzed. Data were analyzed from February 22 to April 25, 2019, using modified intention to treat and per protocol. Interventions: Patients in the PCIA group received general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device. In the EDA group, patients received general anesthesia and intraoperative and postoperative EDA. Main Outcomes and Measures: The primary end point was a composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus within 30 days after surgery. Secondary end points included 30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution. Results: Among the 248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years), the primary composite end point did not differ between the PCIA group (61 [49.2%]) and EDA group (57 [46.0%]) (odds ratio, 1.17; 95% CI, 0.71-1.95 P = .54). Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups. Patients receiving EDA gained more weight by postoperative day 4 than patients receiving PCIA (mean [SD], 4.6 [3.8] vs 3.4 [3.6] kg; P = .03) and received more vasopressors (46 [37.1%] vs 31 [25.0%]; P = .04). Failure of EDA occurred in 23 patients (18.5%). Conclusions and Relevance: This study found that the choice between PCIA and EDA for pain control after pancreatic surgery should not be based on concerns regarding gastrointestinal complications because the 2 procedures are comparable with regard to effectiveness and safety. However, EDA was associated with several shortcomings. Trial Registration: German Clinical Trials Register: DRKS00007784.

2.
Eye (Lond) ; 2020 May 12.
Artigo em Inglês | MEDLINE | ID: mdl-32398853

RESUMO

BACKGROUND/OBJECTIVES: Retinopathy of prematurity (ROP) is a severe neonatal complication potentially leading to visual impairment and blindness. Known risk factors include preterm birth, low birth weight and respiratory support. Limited and contradictory data exist on the risk of maternal smoking during pregnancy on the development of ROP. This study aims to investigate smoking as an independent risk factor for the development of severe ROP (≥stage 3). SUBJECTS/METHODS: This is a single centre retrospective case-control study of prospectively collected clinical data of infants born before 32 weeks of gestation between 2001 and 2012 at a tertiary care university hospital. The association between maternal smoking during pregnancy and the development of severe ROP was analyzed by multivariate logistic regression. RESULTS: In total, n = 751 infants born < 32 weeks of gestation were included in this study. In total, 52.9% (n = 397) were diagnosed with ROP and 10.8% (n = 81) developed ROP ≥ stage 3. In total, 8.4% (n = 63) mothers presented with a history of smoking during pregnancy, which was associated to a higher rate of ROP (OR 2.59, 95% CI 1.10-6.12). Low gestational age, low birth weight and prolonged respiratory support were confirmed as independent risk factors for the development of severe ROP. CONCLUSIONS: To date, this is the largest study evaluating the effect of maternal smoking on the development of ROP. Maternal smoking during pregnancy is identified as an independent risk factor for the development of severe ROP in preterm infants born < 32 weeks of gestation.

3.
BMC Cancer ; 20(1): 353, 2020 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-32334570

RESUMO

BACKGROUND: High-dose (HD) chemotherapy followed by autologous blood stem-cell transplantation (ASCT) is the standard treatment for multiple myeloma (MM) patients. However, the collection of sufficient peripheral blood stem cell (PBSC) grafts can be challenging, and the question arises whether reinfusion of low-dose grafts will lead to a hematopoietic recovery. METHODS: The hematopoietic recovery of 148 MM patients who underwent HD melphalan chemotherapy and received PBSC transplants with varying CD34+ cells doses (3-4 × 106 [n = 86], 2-2.5 × 106 [n = 53], < 2 × 106 [n = 9] per kg body weight [bw]) was analyzed in this retrospective single-center study. RESULTS: All patients reached hematopoietic reconstitution, even those who received < 2 × 106 CD34+ cells/kg bw. 62 (42%) patients received granulocyte-colony-stimulating factor (G-CSF). The median duration to leukocyte recovery ≥1.0 × 109/L was 12 days in every group. The median duration to platelet recovery ≥20 × 109/L was 11, 13 and 13 days, respectively. In the multivariate analysis, a low number of reinfused CD34+ cells was associated with prolonged time until leukocyte reconstitution (p = 0.010, HR 0.607) and platelet recovery (p < 0.001, HR 0.438). G-CSF support significantly accelerated leukocyte (p < 0.001, HR 16.742) but not platelet reconstitution. CONCLUSION: In conclusion, reinfusion of low- and even very-low-dose PBSC grafts leads to sufficient hematopoietic reconstitution. No severe adverse events were observed during or after HD chemotherapy and ASCT in the analyzed cohort. While the impact of CD34+ cell dose is marginal, G-CSF significantly accelerates the leukocyte recovery.

4.
Scand J Gastroenterol ; 55(3): 321-329, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32191146

RESUMO

Background: Small bowel adenocarcinoma (SBA) is a dreadful disease. Patient prognosis is limited due to late presentation and ineffective chemotherapy. PD-1/PD-L1 checkpoint immunotherapy is regarded as a promising approach in several cancer entities. The association of PD-1/PD-L1 expression and its impact on patient prognosis with SBA is unclear. Material and methods: Seventy-five consecutive patients who underwent surgery for SBA were retrospectively analyzed and stained for PD-L1 expression in the tumour or the stroma. Analysis of mismatch repair genes was performed to determine microsatellite status. Kaplan-Meier estimate was used to analyze patient survival. Univariate and multivariable Cox regression-analyses were used to assess the impact of PD-L1 expression and microsatellite status on patient survival.Results: PD-L1 was weakly upregulated within the tumour or the stroma and associated with prolonged survival (p = .0071 and p = .0472, respectively). Fifty-one tumours (68%) revealed microsatellite stability (MSS) and 24 tumours (32%) were microsatellite instable (MSI) without correlating with patient survival (p = .611). Neither PD-L1 expression in the tumour nor in the stroma was identified as an independent risk factor influencing survival (p = .572 and p = .3055).Conclusion: Although PD-L1 expression is associated with prolonged survival, it was not identified as an independent prognostic marker. Microsatellite status did not influence long-term survival.

5.
PLoS One ; 15(3): e0229898, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32142529

RESUMO

OBJECTIVES: To test the feasibility of a randomized controlled study design comparing epidural analgesia (EDA) with continuous wound infiltration (CWI) in respect to postoperative complications and mobility to design a future multicentre randomized controlled trial. DESIGN, SETTING, PARTICIPANTS: CWI has been developed to address drawbacks of EDA. Previous studies have established the equivalent analgesic potential of CWI compared to EDA. This is a single centre, non-blinded pilot randomized controlled trial at a tertiary surgical centre. Patients undergoing elective non-colorectal surgery via a midline laparotomy were randomized to EDA or CWI. Endpoints included recruitment, feasibility of assessing postoperative mobility with a pedometer and morbidity. No primary endpoint was defined and all analyses were explorative. INTERVENTIONS: CWI with local anaesthetics (experimental group) vs. thoracic EDA (control). RESULTS: Of 846 patients screened within 14 months, 71 were randomized and 62 (31 per group) included in the intention-to-treat analysis. Mobility was assessed in 44 of 62 patients and revealed no differences within the first 3 postoperative days. Overall morbidity did not differ between the two groups (measured via the comprehensive complication index). Median pain scores at rest were comparable between the two groups, while EDA was superior in pain treatment during movement on the first, but not on the second and third postoperative day. Duration of preoperative induction of anaesthesia was shorter with CWI than with EDA. Of 17 serious adverse events, 3 were potentially related to EDA, while none was related to CWI. CONCLUSION: This trial confirmed the feasibility of a randomized trial design to compare CWI and EDA regarding morbidity. Improvements in the education and training of team members are necessary to improve recruitment. TRIAL REGISTRATION: DRKS00008023.

6.
Arch Gynecol Obstet ; 301(3): 687-692, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32112180

RESUMO

PURPOSE: Despite safety concerns, ß2-sympathomimetics are still widely used as tocolytic agents. ß-Blockers in turn are used to treat vasculo-proliferative diseases of the newborn such as retinopathy of prematurity (ROP), which may lead to visual impairment and blindness. The scope of this study was to investigate whether antenatal exposure to the ß2-sympathomimetic fenoterol contributes to the development of ROP. METHODS: For this single-center retrospective case-control study of prospectively collected clinical data, all infants born before 32 weeks of gestation between 2001 and 2012 were included. The association of prenatal exposure to fenoterol and the development of ROP were analyzed by multivariate logistic regression. RESULTS: n = 1134 infants < 32 weeks of gestation were screened for eligibility, out of which n = 722 met the inclusion criteria. Exposure to fenoterol (n = 505) was not associated with a higher rate of ROP (OR 0.721, 95% CI 0.463-1.122). Further, duration of exposure (days) did not alter the incidence of ROP (OR 1.001, 95% CI 0.986-1.016). Frequency distribution of different ROP stages and the need for therapeutic intervention was also not affected by prenatal exposure to fenoterol. Risk factors for the development of ROP like low birth weight, low gestational age, prolonged respiratory support and multiple gestation were confirmed in our large study cohort. CONCLUSION: ß2-Sympathomimetic tocolysis does not increase the rate of ROP in premature infants born < 32 weeks of gestation. Our results render fenoterol a safe tocolytic agent regarding neonatal ROP development.

7.
World J Surg ; 2020 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-32130451

RESUMO

BACKGROUND: Atrial fibrillation (AF) represents the most frequent arrhythmic disorder after thoracoabdominal esophageal resection and is associated with a significant increase in perioperative morbidity and mortality. METHODS: In this retrospective cohort study, 167 patients who underwent thoracoabdominal esophagectomy at a large university hospital were assessed. We compared patients who received a 14-day postoperative course of diltiazem with a control group of patients who did not undergo diltiazem prophylaxis. Diltiazem therapy started immediately upon admission to the intensive care unit (ICU) with a loading dose of 0.25 mg/kg bodyweight (i.v.) followed by continuous infusion (0.1 mg/kg bodyweight/h) for 40-48 h. Oral administration (Dilzem® 180 mg uno retard, once a day) was started on postoperative day 3. RESULTS: A total of 117 patients were assessed. Twelve (10.3%) of all patients developed postoperative new-onset atrial fibrillation in the first 30 days after surgical intervention. Prevalence of new-onset AF showed no significant differences between the diltiazem group and control group (p = 0.74). The prevalence of bradycardia (14.7% vs. 3.6%; p = 0.03) and dose of norepinephrine required (0.09 vs. 0.04 µg/kg bodyweight/min; p = 0.04) were higher in the diltiazem group. There were no significant differences between the groups for the median postoperative duration of hospital/ICU stay or mortality. CONCLUSIONS: A prophylactic 14-day postoperative course of diltiazem was not associated with a reduction in new-onset AF or 30-day mortality following thoracoabdominal esophagectomy. Prophylactic diltiazem therapy was associated with drug-related adverse effects such as bradycardia and increased requirement of norepinephrine. German Clinical Trial Registration Number: DKRS00016631.

9.
BMC Musculoskelet Disord ; 21(1): 191, 2020 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-32220253

RESUMO

BACKGROUND: The arthroscopic method offers a less invasive technique of Bankart repair for traumatic anterior shoulder instability. The aim of the study is to determine the mid-/long-term functional outcome, failure rates and predictors of failure after primary arthroscopic Bankart repair for traumatic anterior shoulder instability. METHODS: A total of 100 patients were primarily operated using arthroscopic Bankart repair after traumatic anterior shoulder instability. Medical records were retrospectively reviewed, and patients were assessed using postal questionnaire after a mean follow-up of 8.3 years [3-14]. Clinical assessment was performed using Constant score, Rowe score, and American Shoulder and Elbow Surgeons score. RESULTS: The overall recurrence rate was 22%. The Kaplan-Meier failure-free survival estimates. were 80% at 5 years and 70% at 10 years. Nearly half (54.5%) of recurrences occurred at 2 years postoperative. Compared with normal shoulder, there were statistical differences in all 3 scores. Failure rate was significantly affected by age at the time of surgery with 86% of recurrence cases observed in patients aged 30 years or younger. Nevertheless, Younger age at the time of surgery (P = 0.007) as well age at the time of initial instability (P = 0.03) was found to correlate negatively with early recurrence within 2 years of surgery. Among those with recurrent instability, recurrence rate was found to be higher if there had been more than 5 instability episodes preoperatively (P = 0.01). Return to the preinjury sport and occupational level was possible in 41 and 78%, respectively. CONCLUSION: Failure-free survival rates dropped dramatically over time. Alternative reconstruction techniques should be considered in those aged ≤30 years due to the high recurrence rate.

10.
Artigo em Inglês | MEDLINE | ID: mdl-31897591

RESUMO

BACKGROUND: The degree of preoperative osteoarthritis has been shown to influence the postoperative outcome and the patients' satisfaction rate in hip and knee joint replacement surgery. However, no corresponding information is available for total shoulder arthroplasty (TSA). We therefore set out to evaluate the influence of preoperatively measured end-stage osteoarthritis on the postoperative clinical outcome of TSA. METHODS: A retrospective analysis of 103 anatomic total shoulder replacements (96 patients) was performed. Patients were evaluated radiologically with X-rays in two planes and clinically using the Constant and Murley score (CS) and the self-reported satisfaction with the result. The degree of osteoarthritis was radiographically analyzed with the aid of the classifications according to Kellgren/Lawrence, Gerber, Guyette, and Allain and according to whether complete narrowing of the glenohumeral joint was present or not [bone-on-bone contact (BOB) or no bone-on-bone contact (No BOB)]. RESULTS: The clinical results of TSA did not differ significantly among the various stages of osteoarthritis in any of the classifications (p > 0.05). The CS was significantly higher postoperatively for both the BOB and the No BOB group (p < 0.0001). Patients with BOB had a significantly lower CS preoperatively than patients with No BOB (p = 0.0172). In addition, the preoperative pain level was significantly higher in patients with BOB (p = 0.014). Postoperatively, no significant difference in CS (p = 0.6738) was found between the BOB group and the No BOB group. The mean improvement in CS was not statistically significant (p = 0.2218). CONCLUSION: In contrast to hip and knee joint replacement procedures, a milder grade of osteoarthritis does not adversely influence the functional result or subjective satisfaction rate after TSA. The degree of osteoarthritis on conventional X-rays has no bearing on the postoperative clinical outcome. Therefore, the decision on when to carry out anatomic total shoulder arthroplasty should depend on the patient's pain level and loss of quality of life.

11.
J Gastrointest Surg ; 24(2): 341-352, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30671796

RESUMO

BACKGROUND: The randomized controlled PROPP trial (DKRS00004191) showed that pylorus-resecting pancreatoduodenectomy (PR) is not superior to the pylorus-preserving procedure (PP) in terms of perioperative outcome, specifically in reduction of delayed gastric emptying. Non-superiority of PR was also confirmed in a recent meta-analysis of randomized controlled trials. However, long-term data on morbidity and quality of life after PP compared to PR are sparse. The aim of this study was to investigate long-term outcomes of patients included in the PROPP trial. METHODS: Between February 2013 and June 2016, a total of 188 patients underwent PD and were intraoperatively randomized to either preservation or resection of the pylorus (95 vs. 93 patients). For long-term follow-up, morbidity and quality of life (EORTC QLQ-C30/PAN26) were monitored until January 1, 2018. Statistical analysis was performed on an intention-to-treat basis. RESULTS: The mean duration of follow-up was 34.3 (± 11.3) months. Sixty-three of the 188 patients had died (PP n = 33, PR n = 30), 29 patients were lost to follow-up (PP n = 17, PR n = 12), and the remaining 96 patients were included in long-term follow-up (PP n = 45, PR n = 51). There was no difference between PP and PR patients regarding endocrine and exocrine pancreatic function, receipt of adjuvant/palliative chemotherapy, cancer recurrence, and other relevant characteristics. Late cholangitis occurred significantly more often in patients following pylorus resection (P = 0.042). Reoperations, readmissions to hospital, and quality of life scores except pain were comparable between the two study groups. CONCLUSIONS: Similar to short-term results, long-term follow-up showed no significant differences between pylorus resection compared to pylorus preservation.

12.
Ultraschall Med ; 41(1): 44-51, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30081395

RESUMO

PURPOSE: To assess the value of CEUS in the evaluation of tibial fracture perfusion and its ability to differentiate between physiologic and abnormal fracture healing. MATERIALS AND METHODS: From 2014 to 2017, 107 patients with tibial fractures or tibial non-unions underwent CEUS examination. CEUS was performed at the regular follow-up examination 26 weeks after osteosynthesis or before non-union surgery. Time-intensity curves (TICs) of the contrast enhancement in the fracture gap were generated, and volume parameters such as wash-in rate (WiR), peak enhancement (PE) and wash-in perfusion index (WiPI) were quantified. RESULTS: A total of 34 patients met the inclusion criteria of this study, including 14 consolidated fractures, 12 aseptic non-unions and 8 infected non-unions. WiR, PE and WiPI showed significantly lower values in aseptic non-unions compared to unions (p = 0.009, 0.009, 0.012, resp.). In contrast, infected non-unions showed higher values of WiR, PE and WiPI when compared to unions (p = 0.034, 0.056, 0.029, resp.). CONCLUSION: CEUS represents a feasible method in the assessment of tibial fracture perfusion. Perfusion differences between aseptic and infected tibial non-unions as well as healing tibial fractures could be detected. The deviation of physiologic fracture perfusion seems to be associated with disturbed osseous regeneration leading to non-union.


Assuntos
Meios de Contraste , Fraturas Mal-Unidas , Fraturas da Tíbia , Consolidação da Fratura , Fraturas Mal-Unidas/diagnóstico por imagem , Humanos , Perfusão , Fraturas da Tíbia/diagnóstico por imagem , Ultrassonografia/métodos
13.
World Neurosurg ; 134: e596-e609, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31678440

RESUMO

OBJECTIVE: As a result of the resolution of intravoxel fiber crossing, high-resolution fiber tractography (HRFT) provides advantages over conventional diffusion tensor imaging (DTI) for fiber tractography (FT). Nevertheless, neurosurgically applied FT is still predominantly based on DTI. Although the application of HRFT is evolving, there is still a lack of data about which method should be preferred. With this prospectively designed study, we present our initial experience comparing an analytical Q-ball imaging (QBI) approach with constrained spherical deconvolution (CSD) and conventional DTI-FT considering a particularly neurosurgical perspective. METHODS: For 18 patients with eloquent gliomas in the dominant hemisphere, probabilistic FT based on QBI, CSD, and DTI was performed for the major components of the language-associated pathways using a routine diffusion-weighted sequence. Quantitative analysis evaluated tract density, tract volume (TV), tract length (TL), number of fibers, and tract surface (TS) of the fiber object. RESULTS: Both HRFT models showed a significantly larger mean TV, TL, and TS compared with DTI (for QBI vs. DTI: TV (P = 0.0000), TL (P = 0.0048), and TS (P = 0.0129); for CSD vs. DTI: TV (P = 0.0000), TL (P = 0.0008), and TS (P = 0.0010)). However, results of QBI versus CSD did not differ significantly for these variables: TV (P = 0.1415), TL (P = 0.2837), and TS (P = 0.3692). Bland-Altman analysis supports these findings, suggesting systematically higher values for TV, TL, and TS with HRFT but no relevant differences of either QBI or CSD. Neither tumor volume nor peritumoral edema influenced FT results. CONCLUSIONS: Our quantitative analysis showed no significant differences regarding TV, TL, and TS for the HRFT methods; however, it suggested advantages over DTI-FT in terms of the display of marginal and terminal fibers. In our recently established setting, QBI-FT shows greater potential for integration into the clinical workflow.

15.
Cancers (Basel) ; 11(11)2019 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-31717925

RESUMO

Background: Isometric paravertebral muscle training (IPMT) may improve mobility, pain, and quality of life (QOL) in cancer patients with spinal metastases. However, this regimen remains unproven in patients with unstable spinal metastases (USM), a population at high risk for clinical exacerbation with such interventions. Thus, we conducted this exploratory, non-blinded, randomized controlled trial (NCT02847754) to evaluate the safety/feasibility of IPMT and secondarily assess pain, bone density, pathologic fracture rate, and QOL. Methods: All patients had histologically/radiologically confirmed USM (per Taneichi score) and underwent non-operative management with 5-10 fractions of palliative radiotherapy (RT). Randomization (1:1) groups were IPMT (intervention, INT) or muscle relaxation (control, CON); both lasted 15 min/day and started concurrently with radiotherapy. The primary endpoint was feasibility (completion of training programs three months post-RT). Secondary endpoints were pain response (Visual Analog Scale) and opioid consumption, bone density and pathologic fracture rate, and QOL (European Organization for Research and Treatment of Cancer, EORTC questionnaires). Results: Sixty patients were randomized and 56 received protocol therapy. Mean survival in both groups was 4.4 months. There were no adverse events with either training regimen. Altogether, ≥80% of the planned sessions were completed by 55% (n = 16/29) in CON and 67% (n = 18/27) in INT. Regarding the post-radiotherapy home-based training, ≥80% of planned sessions were completed by 64% (n = 9/14) of the INT cohort. There were no differences in pain scores, opioid consumption, or bone density between arms (p > 0.05 for all). No difference was observed between groups regarding new pathological fractures (INT: n = 1 vs. CON: n = 3) after three months (p = 0.419). There were no QOL differences between arms (all parameters p > 0.05). Conclusions: IPMT is potentially feasible for high-risk USM patients. Future trials adequately powered for relevant endpoints are thus recommended.

16.
Crit Care Med ; 47(12): e999-e1007, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31584458

RESUMO

OBJECTIVES: Sepsis-induced acute kidney injury is the dominant acute kidney injury etiology in critically ill patients and is often associated with a need for renal replacement therapy. The indication and timing of renal replacement therapy are controversially discussed. We hypothesized that the product of the G1-cell cycle arrest biomarkers tissue inhibitor of metalloproteinase-2 and insulin-like growth factor-binding protein 7 ([TIMP-2] × [IGFBP7]), and the soluble urokinase-type plasminogen activator receptor are of diagnostic value for the prediction of septic acute kidney injury courses requiring renal replacement therapy. DESIGN: In this prospective study, critically ill patients were enrolled immediately after the fulfillment of Sepsis-3 criteria. Urinary [TIMP-2] × [IGFBP7] levels over time and serum soluble urokinase-type plasminogen activator receptor levels once at inclusion were measured. The primary endpoint was the development of septic acute kidney injury with the need for renal replacement therapy. Area under the receiver operating characteristic curves, de Long's tests, and logistic regression models were calculated. SETTING: Two ICUs at Heidelberg University Hospital between May 2017 and July 2018. PATIENTS: One-hundred critically ill patients with positive Sepsis-3 criteria. INTERVENTIONS: None. MEASUREMENT AND MAIN RESULTS: Nineteen patients required renal replacement therapy. Diagnostic performance of urinary [TIMP-2] × [IGFBP7] improved over time with the highest area under the receiver operating characteristic curve of 0.89 (95% CI, 0.80-0.98) 24 hours after study inclusion. Soluble urokinase-type plasminogen activator receptor levels at inclusion showed an area under the receiver operating characteristic curve of 0.83 (0.75-0.92). The best discrimination ability for the primary outcome measure was achieved for [TIMP-2] × [IGFBP7] at 24 hours after inclusion by applying a cutoff value of greater than or equal to 0.6 (ng/mL)/1,000 (sensitivity 90.9, specificity 67.1). Soluble urokinase-type plasminogen activator receptor performed best by using a cutoff value of greater than or equal to 8.53 ng/mL (sensitivity 84.2, specificity 82.7). A combination of newly tested biomarkers with cystatin C resulted in a significantly improved diagnostic accuracy. Cystatin C in combination with [TIMP-2] × [IGFBP7] 24 hours outperformed all standard renal parameters (area under the receiver operating characteristic curve 0.93 [0.86-1.00]). CONCLUSIONS: [TIMP-2] × [IGFBP7] and soluble urokinase-type plasminogen activator receptor are promising biomarker candidates for the risk stratification of septic acute kidney injury patients with the need for renal replacement therapy.

17.
J Clin Med ; 8(11)2019 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-31661811

RESUMO

The three-dimensional nature of adolescent idiopathic scoliosis (AIS) necessitates a tridimensional assessment and management. Bracing constitutes the mainstay conservative treatment for mild adolescent idiopathic scoliosis. In the literature hitherto, there has been uncertainty regarding the behavior of the spine, pelvis, and vertebral orientations in the context of bracing, especially in the transverse plane. This poses a challenge to healthcare providers, patients, and their families, as brace treatment, although not as invasive as surgery, is laden with medical and psychological complications and could be considered traumatizing. Hence, a thorough understanding of initial three-dimensional spinal behavior in the context of bracing is important. The purpose of this retrospective study was to investigate the immediate 3D impact of Chêneau-type brace. Thirty-eight patients with AIS undergoing Chêneau-type bracing were included. Patients were stratified according to their structural curve topography into thoracic, thoracolumbar, and lumbar groups. 3D reconstruction of the spine using a dedicated biplanar stereoradiography software with and without the brace was performed. The examined anthropometric radiographic measures were pre- to in-brace variations and differences of spinopelvic parameters and vertebral orientations in the coronal, sagittal, and transverse planes. The complex impact of the Chêneau-type brace on different curves in three planes was delineated. In the coronal plane, the Cobb angle was significantly decreased in all types of curves, and the coronal tilt correction was concentrated in specific segments. The impact of the brace in this study on the sagittal profile was variable, including the loss of thoracic kyphosis and lumbar lordosis. In the transverse plane, an axial vertebral rotation change and detorsion above the apex occurred in the thoracolumbar curves. The results from this exploratory study could shed some light on the initial 3D spinal behavior in the context of bracing and may be of beneficial for treating physicians and brace makers.

18.
Materials (Basel) ; 12(15)2019 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-31382555

RESUMO

Instrumentation failure in the context of spine surgery is attributed to cyclic loading leading to formation of fatigue cracks, which later propagate and result in rod fracture. A biomechanical analysis of the potential impact of electrocautery on the fatigue life of spinal implants has not been previously performed. The aim of this study was to assess the fatigue life of titanium (Ti) and cobalt-chrome (CoCr) rod-screw constructs after being treated with electrocautery. Twelve spinal constructs with CoCr and Ti rods were examined. Specimens were divided into four groups by rod material (Ti and CoCr) and application of monopolar electrocautery on the rods' surface (control-group and electrocautery-group). Electrocautery was applied on each rod at three locations, then constructs were cyclically tested. Outcome measures were load-to-failure, total number of cycles-to-failure, and location of rod failure. Ti-rods treated with electrocautery demonstrated a significantly decreased fatigue life compared to non-treated Ti-rods. Intergroup comparison of cycles-to-failure revealed a significant mean decrease of almost 9 × 105 cycles (p = 0.03). No CoCr-rods failed in this experiment. Electrocautery application on the surface of Ti-rods significantly reduces their fatigue life. Surgeons should exercise caution when using electrocautery in the vicinity of Ti-rods to mitigate the risk of rod failure.

19.
Biomed Pharmacother ; 118: 109318, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31398669

RESUMO

BACKGROUND: In the context of the cholinergic anti-inflammatory pathway, the clinical trial Anticholium® per Se (EudraCT Number: 2012-001650-26, ClinicalTrials.gov NCT03013322) addressed the possibility of taking adjunctive physostigmine salicylate treatment in septic shock from bench to bedside. Pharmacokinetics (PK) are likely altered in critically ill patients; data on physostigmine PK and target concentrations are sparse, particularly for continuous infusion. Our objective was to build a population PK (popPK) model for physostigmine, and further evaluate pharmacodynamics (PD) and concentration-response relationship in this setting. METHODS: In the randomized, double-blind, placebo-controlled trial, 20 patients with perioperative septic shock either received an initial dose of 0.04 mg/kg physostigmine salicylate, followed by continuous infusion of 1 mg/h for up to 120 h, or equivalent volumes of 0.9% sodium chloride (placebo group). Physostigmine plasma concentrations and acetylcholinesterase (AChE) activity were measured; concentration-response associations were evaluated, and popPK and PD modeling was performed with NONMEM. RESULTS: Steady state physostigmine plasma concentrations reached 7.60 ±â€¯2.81 ng/mL (mean ±â€¯standard deviation [SD]). PK was best described by a two-compartment model with linear clearance. Significant covariate effects were detected for body weight and age on clearance, as well as a high inter-individual variability of the central volume of distribution. AChE activity was significantly reduced to 30.5%-50.6% of baseline activity during physostigmine salicylate infusion. A sigmoidal direct effect PD model best described enzyme inhibition by physostigmine, with an estimated half maximal effective concentration (EC50) of 5.99 ng/mL. CONCLUSIONS: PK of physostigmine in patients with septic shock displayed substantial inter-individual variability with body weight and age influencing the clearance. Physostigmine inhibited AChE activity with a sigmoidal concentration-response effect.


Assuntos
Modelos Biológicos , Fisostigmina/análogos & derivados , Choque Séptico/tratamento farmacológico , Idoso , Colinesterases/metabolismo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fisostigmina/administração & dosagem , Fisostigmina/farmacocinética , Fisostigmina/uso terapêutico , Choque Séptico/sangue
20.
Dtsch Arztebl Int ; 116(27-28): 471-478, 2019 07 08.
Artigo em Inglês | MEDLINE | ID: mdl-31431236

RESUMO

BACKGROUND: Improving quality of life (QoL) is an important treatment goal in pancreatic cancer patients. Although the beneficial effects of exercise on QoL are well understood, few studies have investigated more aggressive cancers such as pancreatic cancer. METHODS: Within a randomized trial, we assessed the efficacy of 6-month resistance training on physical functioning (primary outcome) and further QoL-related outcomes. 65 pancreatic cancer patients were assigned to home-based training, supervised training, or a usual care control group. Analysis-of-covariance models on changes from baseline to 6 and 3 months were ap- plied. RESULTS: 47 patients completed the intervention period. After 6 months, no effects of resistance training were observed. However, after 3 months, explorative analyses showed significant between-group mean differences (MD) in favor for resistance training for physical functioning (pooled group: MD=11.0; p=0.016; effect size[ES]=0.31), as well as for global QoL (MD=12.1; p=0.016; effect size=0.56), and other outcomes, such as sleep problems and fatigue. Multiple imputation analyses yielded similar results. Home-based and supervised training performed similarly. CONCLUSION: This first randomized resistance training trial in pancreatic cancer patients indicated clinically relevant improve- ments in QoL after 3 but not after 6 months. Given the severity of pancreatic cancer, exercise recommendations may already commence at surgery.

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