scholarly journals Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open label, phase III study (NUTRILEAK study)

2019 ◽  
Author(s):  
Caroline Gronnier ◽  
Cécile Chambrier ◽  
Alain Duhamel ◽  
Benoît Dervaux ◽  
Denis Collet ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Length Of Hospital Stay ◽  
Phase Iii ◽  
Fistula Closure ◽  
Related Complication ◽  
Open Label ◽  
Closure Rate ◽  
Open Label Phase ◽  
Related Quality ◽  
Health Related

Abstract Background: Postoperative Upper Gastro-Intestinal Fistula (PUGIF) is a devastating complication, leading to a high mortality rate reaching up to 80%, increased length of hospital stay, reduced Health related quality of life (HRQOL) and increased health costs. Nutritional support is a key component of therapy in such cases, related to the high prevalence of malnutrition. In prophylactic setting, enteral nutrition (EN) is associated to shorter hospital stay, lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. In curative settingafter fistula occurrence, there are very few evidences available. We hypothesise that EN increases 30-day fistula closure rate in PUGIF, allowing better HRQOL without increasing morbi-mortality. Methods/Design: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open label phase III trial to assess the efficacy of EN (experimental group) compared with TPN (control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after oesophago-gastric resection including bariatric surgery, duodeno-jejunal resection or pancreatic resection with digestive tract violation) in terms of 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month post-randomization fistula closure rate, time of first fistula closure (in days), medical and surgical treatment-related complication rate at 6 months after randomization, fistula related complication rate at 6 months after randomization, type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month post-randomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 post randomization, mean length of hospital stay, patient’s Health related quality of life (HRQOL) (self-assessment questionnaire), oral feeding time anddirect costs of treatment. A total of 321 patients will be enrolled. Discussion: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. Trial registration: ClinicalTrials.gov, NCT03742752. Registered on 14 November 2018.

scholarly journals Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open label, phase III study (NUTRILEAK study)

2020 ◽  
Author(s):  
Caroline Gronnier ◽  
Cécile Chambrier ◽  
Alain Duhamel ◽  
Benoît Dervaux ◽  
Denis Collet ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Length Of Hospital Stay ◽  
Phase Iii ◽  
Fistula Closure ◽  
Related Complication ◽  
Open Label ◽  
Closure Rate ◽  
Open Label Phase ◽  
Related Quality ◽  
Health Related

Abstract Background: Postoperative Upper Gastro-Intestinal Fistula (PUGIF) is a devastating complication, leading to a high mortality rate reaching up to 80%, increased length of hospital stay, reduced Health related quality of life (HRQOL) and increased health costs. Nutritional support is a key component of therapy in such cases, related to the high prevalence of malnutrition. In prophylactic setting, enteral nutrition (EN) is associated to shorter hospital stay, lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. In curative settingafter fistula occurrence, there are very few evidences available. We hypothesise that EN increases 30-day fistula closure rate in PUGIF, allowing better HRQOL without increasing morbi-mortality. Methods/Design: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open label phase III trial to assess the efficacy of EN (experimental group) compared with TPN (control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after oesophago-gastric resection including bariatric surgery, duodeno-jejunal resection or pancreatic resection with digestive tract violation) in terms of 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month post-randomization fistula closure rate, time of first fistula closure (in days), medical and surgical treatment-related complication rate at 6 months after randomization, fistula related complication rate at 6 months after randomization, type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month post-randomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 post randomization, mean length of hospital stay, patient’s Health related quality of life (HRQOL) (self-assessment questionnaire), oral feeding time anddirect costs of treatment. A total of 321 patients will be enrolled. Discussion: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. Trial registration: ClinicalTrials.gov, NCT03742752. Registered on 14 November 2018.

ELOQUENT-2: A phase III, randomized, open-label trial of lenalidomide/dexamethasone (Len/Dex) with or without elotuzumab (Elo) in relapsed or refractory multiple myeloma (RR MM) (CA204-004).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS8112-TPS8112
Author(s):  
Sagar Lonial ◽  
Paul Gerard Guy Richardson ◽  
Philippe Moreau ◽  
Robert Z. Orlowski ◽  
Jesùs F. San-Miguel ◽  
...  
Keyword(s):  
Objective Response ◽  
Progression Free Survival ◽  
Response Duration ◽  
Surface Glycoprotein ◽  
Phase Iii ◽  
Open Label ◽  
Cell Surface Glycoprotein ◽  
Open Label Phase ◽  
Related Quality ◽  
Duration Of Response

TPS8112 Background: MM remains incurable and patients (pts) typically relapse or become refractory to current treatments. Novel regimens are needed to improve pt outcomes. Elo is a humanized monoclonal IgG1 antibody targeting the cell surface glycoprotein CS1, which is highly expressed on >95% of MM cells. Len/Dex is approved for treatment of relapsed MM and an objective response rate (ORR) of ~60% was reported in phase III trials of this combination in RR MM. In a phase II study (N=73) of Elo (10 or 20 mg/kg) in combination with Len/Dex in pts with RR MM, the 10 mg/kg group (n=36) demonstrated an ORR of 92% and median progression-free survival (PFS) that was not reached after a median follow-up of 14.1 months. Encouraging activity was seen in patients with high-risk cytogenetics and/or stage 2-3 disease. Based on these data, a randomized, open-label phase III trial has been initiated to determine if the addition of Elo to Len/Dex will improve PFS in patients with RR MM compared with Len/Dex alone. Methods: Pts (N=640) with RR MM and 1-3 prior therapies are eligible, including pts with mild or moderate renal impairment. Pts are randomized in a 1:1 ratio to receive 28-day cycles of Len 25 mg PO (days 1-21) and Dex 40 mg PO (days 1, 8, 15 and 22) with or without Elo. Elo dose and schedule is 10 mg/kg IV on days 1, 8, 15, 22 in the first 2 cycles and on days 1 and 15 in subsequent cycles. Dex 8 mg IV + 28 mg PO is used during the weeks with Elo. Treatment will continue until disease progression, death, or withdrawal of consent. Patients will be followed for tumor response every 4 weeks until progressive disease and then survival every 12 weeks. The primary endpoint is PFS (90% power for a hazard ratio [experimental to control arm] of 0.74) and the secondary endpoints are ORR and overall survival. Exploratory endpoints are safety, time to response, duration of response, time to subsequent therapy, health-related quality of life, and pharmacokinetics and immunogenicity of Elo. Potential biomarkers will also be assessed. As of January 10th, 2012, 107 pts were enrolled and 68 pts were treated. NCT01239797.

Reduction in Initial Length of Stay with Rivaroxaban Single-Drug Regimen versus LMWH-VKA Standard of Care: Findings from the EINSTEIN Trial Program

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3419-3419 ◽  
Author(s):  
Bonno van Bellen ◽  
Martin Prins ◽  
Luke Bamber ◽  
Maria Wang ◽  
Anthonie WA Lensing
Keyword(s):  
Hospital Stay ◽  
Length Of Hospital Stay ◽  
Standard Of Care ◽  
Phase Iii ◽  
Treatment Burden ◽  
Median Length ◽  
Open Label ◽  
Parenteral Treatment ◽  
Single Drug ◽  
Long Term Treatment

Abstract Abstract 3419 Background The current standard of care for the treatment of symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) is parenteral low molecular weight heparin (LMWH) or fondaparinux, overlapping with and followed by a vitamin K antagonist (VKA). According to guidelines, parenteral treatment should be discontinued only when patients have reached a stable level of anticoagulation with a VKA; defined as 2 consecutive measurements of international normalized ratio (INR) >2.0 at least 24 hours apart. Compared with the previous standard of care, continuous infusion of unfractionated heparin, LMWH has made outpatient treatment feasible and lowered the treatment burden for patients, while reducing healthcare system costs. However, based on local practice or initial severity of disease many patients, especially those with PE, are still hospitalized, with discharge delayed until parenteral treatment can be discontinued. Rivaroxaban is an oral anticoagulant that produces stable levels of anticoagulation without the need for dose adjustments or routine coagulation monitoring for acute or long-term treatment. With its oral mode of administration and without the need for parenteral bridging therapy, rivaroxaban has the potential to allow discharge based on a patient's clinical condition without the additional requirement of achieving adequate oral anticoagulation levels, thereby further reducing healthcare costs and increasing convenience for patients. Aims We investigated the potential of rivaroxaban to reduce the length of initial hospitalization and the proportion of patients hospitalized, using data from the EINSTEIN DVT and EINSTEIN PE studies. Methods The EINSTEIN DVT and EINSTEIN PE studies were large, open-label, randomized, non-inferiority phase III trials comparing oral rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with dose-adjusted subcutaneous enoxaparin (1.0 mg/kg twice daily) overlapping with, and followed by, warfarin or acenocoumarol (INR 2.0–3.0). There were no instructions in the protocols of the studies with regard to hospital admission and/or discharge, which were left to the judgment of the attending physician. Length of hospital stay was evaluated from investigator records of dates of admission and discharge. All analyses were carried out in the intention-to-treat population using the van Elteren test, a stratified non-parametric test of significance, stratified by intended treatment duration. Analyses were exploratory with no adjustments for multiplicity. Results In the EINSTEIN DVT trial, 1781 of 3449 (52%) patients were hospitalized for the qualifying event, with similar proportions in each treatment arm (Table). However, the median length of hospital stay was significantly shorter in the rivaroxaban arm compared with the enoxaparin/VKA arm (5.0 vs 8.0 days; p<0.0001). In the EINSTEIN PE trial, 4328 of 4832 (90%) patients were hospitalized, with similar proportions in each treatment arm. Again, the median length of hospital stay was significantly shorter in patients receiving rivaroxaban than in patients receiving enoxaparin/VKA (6.0 vs 7.0 days; p<0.0001). Conclusion These results indicate that a single-drug anticoagulation regimen using rivaroxaban significantly reduces the length of hospital stay for patients admitted for DVT and/or PE, relative to standard of care. This has the potential to reduce the treatment burden for patients and healthcare systems. Disclosures: van Bellen: Bayer Brazil: Membership on an entity's Board of Directors or advisory committees. Prins:Bayer Healthcare: Consultancy, Honoraria. Bamber:Bayer Healthcare: Employment. Wang:Bayer Healthcare: Employment. Lensing:Bayer Healthcare: Employment.

scholarly journals The impact of physical training on length of hospital stay and physical function in patients hospitalized with community-acquired pneumonia: protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Camilla Koch Ryrsø ◽  
Daniel Faurholt-Jepsen ◽  
Christian Ritz ◽  
Bente Klarlund Pedersen ◽  
Maria Hein Hegelund ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Hospital Stay ◽  
Usual Care ◽  
Physical Training ◽  
Length Of Hospital Stay ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Abstract Background Community-acquired pneumonia (CAP) is a leading cause of hospitalization worldwide. Bed rest with low levels of physical activity is common during periods of hospitalization and leads to functional decline as well as increased risk of complications. The aim of this study is to assess the effect of supervised physical training during hospitalization with CAP compared with standard usual care for CAP on length of hospital stay, risk of readmission, mortality risk, physical capacity, muscle and fat mass, muscle strength, metabolic function, systemic inflammation, health-related quality of life, and physical activity level. Methods This study is a randomized controlled trial with three parallel experimental arms. Based on a sample size calculation, a total of 210 patients admitted with CAP at Nordsjællands Hospital, Hillerød, Denmark, will be recruited. Patients will be randomly allocated (1:1:1) to either (1) standard usual care, (2) standard usual care combined with in-bed cycling, or (3) standard usual care combined with exercises from a booklet. The primary outcome is differences in length of hospital stay between groups, with secondary outcomes being differences between groups in time to (1) 90-day readmission and (2) 180-day mortality. Further secondary outcomes are differences in changes from baseline between groups in (3) lean mass, (4) fat mass, (5) fat-free mass, (6) physical capacity, (7) health-related quality of life, (8) systemic inflammation, and (9) physical activity level after discharge. Data on length of hospital stay, readmission, and mortality will be collected from patient files, while total lean, fat, and fat-free mass will be quantitated by dual-energy x-ray absorptiometry and bioelectrical impedance analysis. Physical function will be assessed using grip strength, 30-s chair stand tests, and Barthel Index-100. Health-related quality of life will be assessed with the EQ-5D-5L questionnaire. Systemic inflammation will be assessed in blood samples, while accelerometers are used for measuring physical activity. Discussion If a simple physical training program appears to diminish the impact of critical illness and hospitalization on clinical outcome, mobility, and health-related quality of life, it may lead to novel therapeutic approaches in the treatment of patients hospitalized with CAP. Trial registration ClinicalTrials.gov NCT04094636. Registered on 1 April 2019

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