DIVA patient Dotaz Zobrazit nápovědu
BACKGROUND: There are several types of LPC (long peripheral catheters) that vary in length, size, insertion method, and cost. The aim of the study was to evaluate whether ultrasonography can be useful for the selection of the suitable LPC in DIVA (difficult intravenous access) patients. METHODS: Based on the ultrasonographic examination, a long peripheral catheter was selected. A 6.4 cm LPC into a vein at a depth of up to 0.5 cm, a 8.5 cm LPC into a vein at a depth up to 1.5 cm, and a 9.8 cm catheter at a depth up to 2 cm using the cannula over needle method. A 12 cm catheter was inserted into the deeper veins using the direct Seldinger method. The catheter diameter was no more than 33% vein diameter. Dwell time and the number of complications of four vascular devices were recorded and compared. RESULTS: One thousand one hundred fifty-six patients, average age 76 years (19-102), 501 men and 655 women, were included in the study. Average dwelling time was 10 days (1-30), there were 136 complications (11.7%). A catheter 6.4 cm long was inserted in 346 (29.8%), 8.5 cm in 140 (12.1%), 9.8 cm in 320 (27, 5%), and 12 cm in 356 (30.6%) patients. There were no significant differences in dwelling time, rate, and type of complications among the four catheters used. CONCLUSION: Our results confirm that ultrasound examination can be useful for the selection of the suitable long peripheral catheter in DIVA patients.
- Klíčová slova
- DIVA patient, Long peripheral catheter, complications, indwelling time, ultrasonography,
- MeSH
- časové faktory MeSH
- cévní přístupy MeSH
- design vybavení * MeSH
- dospělí MeSH
- intervenční ultrasonografie * MeSH
- klinické rozhodování MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- periferní katetrizace * přístrojové vybavení škodlivé účinky MeSH
- prediktivní hodnota testů * MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- zaváděcí katétry * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
BACKGROUND: Long peripheral catheter is 6-15 cm long vascular device. The aim of the study was to compare the frequency of complications of two types of long peripheral catheters with different length inserted in DIVA patients. METHODS: Under ultrasound navigation 2.7F 6.4 cm or 4Fr 12 cm long peripheral catheter was inserted. Complications of both long peripheral catheters were prospectively observed and their relationship to the patient's age, gender, selected vein, number of punctures and Barthel score system was evaluated. RESULTS: Ninety-three 12 cm and fifty-five 6.4 cm long peripheral catheters were inserted. Median of dwelling time was 8 days for 6.4 cm and 9 days for 12 cm long peripheral catheter. There were 17 (26%) complications in 6.4 cm (38/1000 catheter days) and 15 (16%) in 12 cm catheter (17/1000 catheter days), p = 0.04. The complications of both peripheral catheters were not associated with the age of patients, gender, number of punctures and selected vein for insertion. Unlike 12 cm catheter, the complications of 6.4 cm long peripheral catheter were significantly associated with the result of Barthel scoring system (p = 0.003). CONCLUSION: The frequency of complications was more common with 6,4 cm than with 12 cm catheter.
- Klíčová slova
- Barthel scoring system, Long peripheral catheter, complication, vascular access,
- MeSH
- intravenózní podání MeSH
- katétry MeSH
- lidé MeSH
- periferní katetrizace * škodlivé účinky MeSH
- punkce MeSH
- ultrasonografie MeSH
- zaváděcí katétry MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Purpose: To investigate the effect of patient specific vessel cooling on head and neck hyperthermia treatment planning (HTP). Methods and materials: Twelve patients undergoing radiotherapy were scanned using computed tomography (CT), magnetic resonance imaging (MRI) and contrast enhanced MR angiography (CEMRA). 3D patient models were constructed using the CT and MRI data. The arterial vessel tree was constructed from the MRA images using the 'graph-cut' method, combining information from Frangi vesselness filtering and region growing, and the results were validated against manually placed markers in/outside the vessels. Patient specific HTP was performed and the change in thermal distribution prediction caused by arterial cooling was evaluated by adding discrete vasculature (DIVA) modeling to the Pennes bioheat equation (PBHE). Results: Inclusion of arterial cooling showed a relevant impact, i.e., DIVA modeling predicts a decreased treatment quality by on average 0.19 °C (T90), 0.32 °C (T50) and 0.35 °C (T20) that is robust against variations in the inflow blood rate (|ΔT| < 0.01 °C). In three cases, where the major vessels transverse target volume, notable drops (|ΔT| > 0.5 °C) were observed. Conclusion: Addition of patient-specific DIVA into the thermal modeling can significantly change predicted treatment quality. In cases where clinically detectable vessels pass the heated region, we advise to perform DIVA modeling.
- Klíčová slova
- Hyperthermia, discrete vasculature, head and neck, hyperthermia treatment planning, thermal modelling,
- MeSH
- cévy anatomie a histologie diagnostické zobrazování MeSH
- indukovaná hypertermie * MeSH
- lidé MeSH
- magnetická rezonanční tomografie MeSH
- nádory hlavy a krku krevní zásobení diagnostické zobrazování terapie MeSH
- počítačem asistovaná terapie MeSH
- počítačová rentgenová tomografie MeSH
- počítačové modelování podle konkrétního pacienta * MeSH
- studie proveditelnosti MeSH
- teplota MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
BACKGROUND: Sparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis. METHODS: PROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin-angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850. FINDINGS: Between Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6-110) was -2·7 mL/min per 1·73 m2 per year versus -3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1-week 110) was -2·9 mL/min per 1·73 m2 per year versus -3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI -0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (-42·8%, 95% CI -49·8 to -35·0, with sparsentan versus -4·4%, -15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals. INTERPRETATION: Over 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function. FUNDING: Travere Therapeutics.
- MeSH
- antagonisté receptorů pro angiotenzin škodlivé účinky MeSH
- chronické selhání ledvin * MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- IgA nefropatie * farmakoterapie MeSH
- irbesartan škodlivé účinky MeSH
- lidé MeSH
- proteinurie farmakoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- antagonisté receptorů pro angiotenzin MeSH
- irbesartan MeSH
- sparsentan MeSH Prohlížeč
BACKGROUND: An unmet need exists for focal segmental glomerulosclerosis (FSGS) treatment. In an 8-week, phase 2 trial, sparsentan, a dual endothelin-angiotensin receptor antagonist, reduced proteinuria in patients with FSGS. The efficacy and safety of longer-term treatment with sparsentan for FSGS are unknown. METHODS: In this phase 3 trial, we enrolled patients with FSGS (without known secondary causes) who were 8 to 75 years of age; patients were randomly assigned to receive sparsentan or irbesartan (active control) for 108 weeks. The surrogate efficacy end point assessed at the prespecified interim analysis at 36 weeks was the FSGS partial remission of proteinuria end point (defined as a urinary protein-to-creatinine ratio of ≤1.5 [with protein and creatinine both measured in grams] and a >40% reduction in the ratio from baseline). The primary efficacy end point was the estimated glomerular filtration rate (eGFR) slope at the time of the final analysis. The change in eGFR from baseline to 4 weeks after the end of treatment (week 112) was a secondary end point. Safety was also evaluated. RESULTS: A total of 371 patients underwent randomization: 184 were assigned to receive sparsentan and 187 to receive irbesartan. At 36 weeks, the percentage of patients with partial remission of proteinuria was 42.0% in the sparsentan group and 26.0% in the irbesartan group (P = 0.009), a response that was sustained through 108 weeks. At the time of the final analysis at week 108, there were no significant between-group differences in the eGFR slope; the between-group difference in total slope (day 1 to week 108) was 0.3 ml per minute per 1.73 m2 of body-surface area per year (95% confidence interval [CI], -1.7 to 2.4), and the between-group difference in the slope from week 6 to week 108 (i.e., chronic slope) was 0.9 ml per minute per 1.73 m2 per year (95% CI, -1.3 to 3.0). The mean change in eGFR from baseline to week 112 was -10.4 ml per minute per 1.73 m2 with sparsentan and -12.1 ml per minute per 1.73 m2 with irbesartan (difference, 1.8 ml per minute per 1.73 m2; 95% CI, -1.4 to 4.9). Sparsentan and irbesartan had similar safety profiles, and the frequency of adverse events was similar in the two groups. CONCLUSIONS: Among patients with FSGS, there were no significant between-group differences in eGFR slope at 108 weeks, despite a greater reduction in proteinuria with sparsentan than with irbesartan. (Funded by Travere Therapeutics; DUPLEX ClinicalTrials.gov number, NCT03493685.).
- MeSH
- biologické markery MeSH
- dítě MeSH
- dospělí MeSH
- fokálně segmentální glomeruloskleróza * komplikace farmakoterapie patofyziologie MeSH
- hodnoty glomerulární filtrace MeSH
- indukce remise MeSH
- irbesartan * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- kreatinin MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- proteinurie * farmakoterapie etiologie MeSH
- senioři MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- biologické markery MeSH
- irbesartan * MeSH
- kreatinin MeSH
- sparsentan MeSH Prohlížeč