scholarly journals Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036893
Author(s):  
Francesco Peyronel ◽  
Elisabetta Parenti ◽  
Paride Fenaroli ◽  
Giuseppe Daniele Benigno ◽  
Giovanni Maria Rossi ◽  
...  
Keyword(s):  
Clinical Problem ◽  
Randomised Clinical Trial ◽  
Sodium Concentration ◽  
Second Phase ◽  
Intradialytic Hypotension ◽  
Open Label ◽  
Maintenance Haemodialysis ◽  
Institutional Ethics ◽  
Patient Will ◽  
Dialysate Sodium

IntroductionIn patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH) is a clinical problem that nephrologists and dialysis nurses face daily in their clinical routine. Despite the technological advances in the field of HD, the incidence of hypotensive events occurring during a standard dialytic treatment is still very high. Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term. Various strategies aimed at preventing IDH are currently available, but there is lack of conclusive data on more integrated approaches combining different interventions.Methods and analysisThis is a prospective, randomised, open-label, crossover trial (each subject will be used as his/her own control) that will be performed in two distinct phases, each of which is divided into several subphases. In the first phase, 27 HD sessions for each patient will be used, and will be aimed at the validation of a new ultrafiltration (UF) profile, designed with an ascending/descending shape, and a standard dialysate sodium concentration. In the second phase, 33 HD sessions for each patient will be used and will be aimed at evaluating the combination of different UF and sodium profiling strategies through individualised dialysate sodium concentration.Ethics and disseminationThe trial protocol has been reviewed and approved by the local Institutional Ethics Committee (Comitato Etico AVEN, prot. 43391 22.10.19). The results of the trial will be presented at local and international conferences and submitted for publication to a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT03949088).

Evidence of Profiled Hemodialysis Efficacy in the Treatment of Intradialytic Hypotension

1998 ◽  
Vol 21 (7) ◽  
pp. 398-402 ◽  
Author(s):  
L. Colì ◽  
G. La Manna ◽  
V. Dalmastri ◽  
A. De Pascalis ◽  
G. Pace ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Blood Volume ◽  
Sodium Concentration ◽  
Dialysis Session ◽  
Intradialytic Hypotension ◽  
Dialysis Patients ◽  
Non Invasive ◽  
Comparison Of The Results ◽  
Weight Decrease ◽  
Dialysate Sodium

In the last 10 years the percentage of dialysis patients suffering from clinical intradialytic intolerance has greatly increased. Profiled hemodialysis (PHD) is a new technical approach, alternative to standard hemodialysis (SHD) for the treatment of intradialytic symptomatic hypotension. It is based on intradialytic modulation of the dialysate sodium concentration, using a dialysate sodium concentration profile elaborated by a new mathematical kinetic model. The aim of PHD is to reduce the intradialytic blood volume decrease, thanks to a dialysate sodium profile, which allows a reduction in the plasma osmolarity decrease, thereby boosting intravascular fluid refilling. This work aims at clinically validating the PHD technique, by testing its ability, against SHD, to maintain a more stable intradialytic blood volume; this evaluation was supported by monitoring some hemodynamic parameters. Twelve dialysis patients on SHD treatment were selected because of their intradialytic symptomatic hypotension. Twelve SHD (one per patient) and 12 PHD sessions (one per patient) were performed to achieve the same sodium mass removal and body weight decrease on both PHD and SHD. During these sessions we monitored the blood volume variation % by the critline (a non invasive blood volume monitoring device), the mean blood pressure and heart rate directly and, finally, the stroke volume and cardiac output indirectly by bidimensional doppler-echocardiography. Comparison of the results obtained with the two techniques shows PHD to achieve a significantly more stable blood volume, blood pressure and cardiovascular function than SHD, in particular during the second and the third hour of the dialysis session.

scholarly journals How Would You Prescribe the Dialysate Sodium Concentration for Your Patients?

2021 ◽  
Vol 2 (1) ◽  
pp. 1-3
Author(s):  
Friedrich K. Port
Keyword(s):  
Blood Pressure ◽  
Recent Trend ◽  
Sodium Concentration ◽  
Intradialytic Hypotension ◽  
Sodium Removal ◽  
Low Sodium ◽  
Interdialytic Weight Gain ◽  
Increased Risk ◽  
Dialysate Sodium ◽  
Intradialytic Symptoms

Low sodium dialysate was commonly used in the early year of hemodialysis to enhance diffusive sodium removal beyond its convective removal by ultrafiltration. However, disequilibrium syndrome was common, particularly when dialysis sessions were reduced to 4 h. The recent trend of lowering the DNa from the most common level of 140 mEq/L has been associated with intradialytic hypotension and increased risk of hospitalization and mortality. Higher DNa also has disadvantages, such as higher blood pressure and greater interdialytic weight gain, likely due to increased thirst. My assessment of the evidence leads me to choose DNa at the 140 level for most patients and to avoid DNa below 138. Patients with intradialytic symptoms may benefit from DNa 142 mEq/L, if they can avoid excessive fluid weight gains.

scholarly journals A study protocol for a multicentre randomised clinical trial evaluating the safety and feasibility of a bioengineered human allogeneic nanostructured anterior cornea in patients with advanced corneal trophic ulcers refractory to conventional treatment

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016487 ◽  
Author(s):  
Miguel González-Andrades ◽  
Rosario Mata ◽  
María del Carmen González-Gallardo ◽  
Santiago Medialdea ◽  
Salvador Arias-Santiago ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Conventional Treatment ◽  
Randomised Clinical Trial ◽  
Corneal Graft ◽  
Control Treatment ◽  
Second Phase ◽  
Corneal Transplant ◽  
Open Label ◽  
Biological Behaviour ◽  
Human Donor

IntroductionThere is a need to find alternatives to the use of human donor corneas in transplants because of the limited availability of donor organs, the incidence of graft complications, as well as the inability to successfully perform corneal transplant in patients presenting limbal deficiency, neo-vascularized or thin corneas, etc. We have designed a clinical trial to test a nanostructured fibrin-agarose corneal substitute combining allogeneic cells that mimics the anterior human native cornea in terms of optical, mechanical and biological behaviour.Methods and analysisThis is a phase I-II, randomised, controlled, open-label clinical trial, currently ongoing in ten Spanish hospitals, to evaluate the safety and feasibility, as well as clinical efficacy evidence, of this bioengineered human corneal substitute in adults with severe trophic corneal ulcers refractory to conventional treatment, or with sequelae of previous ulcers. In the initial phase of the trial (n=5), patients were sequentially recruited, with a safety period of 45 days, receiving the bioengineered corneal graft. In the second phase of the trial (currently ongoing), subjects are block randomised (2:1) to receive either the corneal graft (n=10), or amniotic membrane (n=5), as the control treatment. Adverse events, implant status, infection signs and induced neovascularization are evaluated as determinants of safety and feasibility of the bioengineered graft (main outcomes). Study endpoints are measured along a follow-up period of 24 months, including 27 post-implant assessment visits according to a decreasing frequency. Intention to treat, and per protocol, and safety analysis will be performed.Ethics and disseminationThe trial protocol received written approval by the corresponding Ethics Committee and the Spanish Regulatory Authority and is currently recruiting subjects. On completion of the trial, manuscripts with the results of phases I and II of the study will be published in a peer-reviewed journal.Trial registrationCT.gov identifier:NCT01765244(Jan2013). EudraCT number: 2010-024290-40 (Dec2012).

scholarly journals Clinical Effects of Standard and Individualized Dialysate Sodium in Patients on Maintenance Hemodialysis

2016 ◽  
Vol 4 (2) ◽  
pp. 248-252 ◽  
Author(s):  
Natasa Eftimovska–Otovic ◽  
Olivera Stojceva-Taneva ◽  
Risto Grozdanovski ◽  
Saso Stojcev
Keyword(s):  
Blood Pressure ◽  
Sodium Concentration ◽  
The Other ◽  
Second Phase ◽  
Clinical Effects ◽  
Hypertensive Patients ◽  
Muscle Cramps ◽  
Interdialytic Weight Gain ◽  
Set Up ◽  
Dialysate Sodium

BACKGROUND: The degree to which the dialysate prescription and, in particular, the dialysate sodium concentration influences blood pressure and interdialytic weight gain (IDWG) via changes in sodium flux, plasma volume or the other parameters is not well understood. The aim of the study was to investigate whether dialysis patients will have some beneficial effects of dialysate sodium set up according to serum sodium or sodium modeling.MATERIAL AND METHODS: Ninety-two nondiabetic subjects (52 men and 40 women) performed 12 consecutive hemodialysis (HD) sessions (4 weeks) with dialysate sodium concentration set up on 138 mmol/L (standard sodium – first phase), followed by 24 sessions (second phase) wherein dialysate sodium was set up according to individualized sodium. Variables of interest were: systolic, diastolic and mean blood pressure, pulse, IDWG, thirst score – (Xerostomia Inventory (XI) and Dialysis Thirst Inventory (DTI)) and side effects (occurrence of hypotension and muscle cramps). After the first phase, the subjects were divided into 3 groups: normotensive (N=76), hypertensive (N= 11) and hypotensive (N=5) based on the average pre-HD systolic BP during the whole period of the first phase.RESULTS: Sodium individualization resulted in significantly lower blood pressure (133.61 ± 11.88 versus 153.60 ± 14.26 mmHg; p=0.000) and IDWG (2.21 ± 0.93 versus 1.87 ± 0.92 kg; p=0.018) in hypertensive patients, whereas normotensive patients showed only significant decrease in IDWG (2.21 ± 0.72 versus 2.06 ± 0.65, p=0,004). Sodium profiling in hypotensive patients significantly increased IDWG (2.45 vs. 2.74, p= 0,006), and had no impact on blood pressure. Thirst score was significantly lower in normotensive patients with individualized-sodium HD and showed no change in the other two groups. During the second phase, hypotension occurred in only 1 case and muscle cramps in 10 normotensive patients.CONCLUSION: Individualized sodium resulted in clinical benefits in normotensive and hypertensive patients.

scholarly journals What Is the Optimal Sodium Concentration in the Dialysate?

2021 ◽  
Vol 2 (1) ◽  
pp. 4-5
Author(s):  
Salvador López-Gil ◽  
Magdalena Madero
Keyword(s):  
Lung Ultrasound ◽  
Sodium Intake ◽  
Dry Weight ◽  
Sodium Concentration ◽  
Dietary Sodium ◽  
Volume Status ◽  
Intradialytic Hypotension ◽  
Close Monitoring ◽  
Relative Blood Volume ◽  
Dialysate Sodium

Based on our experience in our hemodiafiltration unit we would recommend a personalized isonatremic dialysate bath. We currently prescribe 137 meq (isonatremic) or delta dialysate Na/serum Na less than 2 meq. In addition to the sodium prescribed in the dialysate, for the majority of our patients we do not restrict dietary sodium or water intake. The average sodium intake is 2775 mg per day and blood pressure is maintained without hypertensive medications. We acknowledge that part of the success for achieving dry weight may not be attributable only to the dialysate sodium but is likely the result of a combination of multiple factors such as convection therapy, cooling of dialysate, close monitoring of volume status during sessions with relative blood volume, presence of a nephrologist during all sessions and assessing volume status regularly with lung ultrasound and bioimpedance. In our experience, exercising during hemodialysis has additionally been associated with better hemodynamic status and less intradialytic hypotension. Moreover, we acknowledge there is little evidence to support a gradient dialysate to serum sodium of less than 2 meq and that our approach may not be optimal.

scholarly journals Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041458
Author(s):  
Vicki Anderson ◽  
Vanessa C Rausa ◽  
Nicholas Anderson ◽  
Georgia Parkin ◽  
Cathriona Clarke ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Normal Activity ◽  
Secondary Outcome ◽  
Open Label ◽  
Human Research Ethics ◽  
Postconcussive Symptoms ◽  
Study Results ◽  
Registration Number ◽  
Initial Injury

IntroductionWhile most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3 months postconcussion.Methods and analysisIn this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8–18 years will be recruited from The Royal Children’s Hospital (The RCH) emergency department, or referred by a clinician, within 17 days of initial injury. Based on parent ratings of their child’s PCS at ~10 days postinjury, symptomatic children (≥2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3 weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1 hour of intervention each week, for up to 8 weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3 months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.Ethics and disseminationEthics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.Trial registration numberACTRN12617000418370; pre-results.

scholarly journals ANalgesic Efficacy and safety of MOrphiNe versus methoxyflurane in patients with acute myocardial infarction: the rationale and design of the ANEMON-SIRIO 3 study: a multicentre, open-label, phase II, randomised clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e043330
Author(s):  
Aldona Kubica ◽  
Agata Kosobucka ◽  
Piotr Niezgoda ◽  
Piotr Adamski ◽  
Katarzyna Buszko ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Analgesic Efficacy ◽  
Randomised Clinical Trial ◽  
Ethical Standards ◽  
Loading Dose ◽  
Efficacy And Safety ◽  
Open Label ◽  
Analgesic Treatment ◽  
Open Label Phase ◽  
St Elevation

IntroductionThe unfavourable influence of morphine on the pharmacokinetics of ticagrelor resulting in weaker and retarded antiplatelet effect in patients with acute coronary syndrome (ACS) has been previously shown. Replacing morphine with methoxyflurane, a potent, non-opioid analgesic agent, that does not weaken or delay the effect of antiplatelet agents may improve the clinical efficacy of treatment of patients with ACS.MethodsThe ANEMON-SIRIO 3 study was designed as a multicentre, open-label, phase II, randomised clinical trial aimed to test the analgesic efficacy and safety of methoxyflurane in patients with ACS. The study population will comprise patients with ST-elevation myocardial infarction or non-ST-elevation ACS admitted to the study centres with typical chest pain requiring analgesic treatment. Before percutaneous coronary intervention (PCI) for the patients with index ACS will be randomly assigned in 1:1 ratio to receive methoxyflurane administered by inhalation, or to obtain morphine administered intravenously. Analgesic treatment will be followed by 300 mg loading dose of aspirin and 180 mg loading dose of ticagrelor. Patients will be assessed with regard to pain intensity according to the Numeric Pain Rating Scale at baseline, 3 min after study drug administration and immediately after PCI. Moreover, patients will be actively monitored with regard to the occurrence of side effects of evaluated therapies, as well as adverse events that may be related to insufficient platelet inhibition (no-reflow phenomenon assessed immediately after PCI, administration of GPIIb/IIIa inhibitors during PCI, acute stent thrombosis).Ethics and disseminationThe study will be conducted in six Polish clinical centres from the beginning of in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.Trial registration detailsClinicalTrials.gov, NCT04476173.

scholarly journals The Second of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients

2021 ◽  
Author(s):  
Z Paul Lorenc ◽  
Jeffrey M Adelglass ◽  
Rui L Avelar ◽  
Leslie Baumann ◽  
Kenneth R Beer ◽  
...  
Keyword(s):  
Phase Ii ◽  
Botulinum Toxin Type A ◽  
Study Drug ◽  
Botulinum Toxin Type ◽  
Second Phase ◽  
Repeat Dose ◽  
Serum Samples ◽  
Open Label ◽  
Blurred Vision ◽  
Line Scale

Abstract Background PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. Objectives The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. Methods This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as independently assessed by both investigator and patient on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment (IT) of 20 U prabotulinumtoxinA (4 U/0.1 mL final vacuum-dried formulation injected into 5 glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety outcomes were evaluated throughout the study. Results The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug–related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug–related AEs. Eight patients (1.4%) experienced study drug–related AEs of special interest: 5 experienced eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none were study drug related. A total of 4060 serum samples were tested for antibotulinum toxin antibodies; no seroconversion was observed. Conclusions The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was confirmed in this second phase II study based on a broad range of outcomes.

scholarly journals Bias in the Determination of Dialysate Sodium Concentration Set According to Conductivity Relative to Indirect Ion-Selective Measurement Techniques

2020 ◽  
Vol 5 (6) ◽  
pp. 931-934
Author(s):  
Rayees Sheikh ◽  
Swapnil Hiremath ◽  
Edward G. Clark ◽  
Ayub Akbari ◽  
Christopher McCudden ◽  
...  
Keyword(s):  
Measurement Techniques ◽  
Sodium Concentration ◽  
Dialysate Sodium
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