scholarly journals Intravenous albumin for the prevention of hemodynamic instability during sustained low-efficiency dialysis: a randomized controlled feasibility trial (The SAFER-SLED Study)

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Edward G. Clark ◽  
Lauralyn McIntyre ◽  
Irene Watpool ◽  
Jennifer W. Y. Kong ◽  
Tim Ramsay ◽  
...  
Keyword(s):  
Kidney Injury ◽  
Severity Of Illness ◽  
Study Groups ◽  
Hemodynamic Instability ◽  
Saline Group ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Saline Control ◽  
Open Label ◽  
Low Efficiency

Abstract Background Hemodynamic instability is a frequent complication of sustained low-efficiency dialysis (SLED) treatments in the ICU. Intravenous hyperoncotic albumin may prevent hypotension and facilitate ultrafiltration. In this feasibility trial, we sought to determine if a future trial, powered to evaluate clinically relevant outcomes, is feasible. Methods This single-center, blinded, placebo-controlled, randomized feasibility trial included patients with acute kidney injury who started SLED in the ICU. Patients were randomized to receive 25% albumin versus 0.9% saline (control) as 100 mL boluses at the start and midway through SLED, for up to 10 sessions. The recruitment rate and other feasibility outcomes were determined. Secondary exploratory outcomes included ultrafiltration volumes and metrics of hemodynamic instability. Results Sixty patients (271 SLED sessions) were recruited over 10 months. Age and severity of illness were similar between study groups. Most had septic shock and required vasopressor support at baseline. Protocol adherence occurred for 244 sessions (90%); no patients were lost to follow-up; no study-related adverse events were observed; open label albumin use was 9% and 15% in the albumin and saline arms, respectively. Ultrafiltration volumes were not significantly different. Compared to the saline group, the albumin group experienced less hemodynamic instability across all definitions assessed including a smaller absolute decrease in systolic blood pressure (mean difference 10.0 mmHg, 95% confidence interval 5.2–14.8); however, there were significant baseline differences in the groups with respect to vasopressor use prior to SLED sessions (80% vs 61% for albumin and saline groups, respectively). Conclusions The efficacy of using hyperoncotic albumin to prevent hemodynamic instability in critically ill patients receiving SLED remains unclear. A larger trial to evaluate its impact in this setting, including evaluating clinically relevant outcomes, is feasible. Trial registration ClinicalTrials.gov (NCT03665311); First Posted: Sept 11th, 2018. https://clinicaltrials.gov/ct2/show/NCT03665311?term=NCT03665311&draw=2&rank=1

scholarly journals Intravenous Albumin for the Prevention of Hemodynamic Instability During Sustained Low-Efficiency Dialysis. A Randomized Controlled Feasibility Trial. (The SAFER-SLED Study)

2021 ◽  
Author(s):  
Edward Clark ◽  
Lauralyn McIntyre ◽  
Irene Watpool ◽  
Jennifer WY. Kong ◽  
Tim Ramsay ◽  
...  
Keyword(s):  
Kidney Injury ◽  
Severity Of Illness ◽  
Study Groups ◽  
Hemodynamic Instability ◽  
Saline Group ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Saline Control ◽  
Open Label ◽  
Low Efficiency

Abstract Background: Hemodynamic instability is a frequent complication of sustained low-efficiency dialysis (SLED) treatments in the ICU. Intravenous hyperoncotic albumin may prevent hypotension and facilitate ultrafiltration. In this feasibility trial, we sought to determine if a future trial, powered to evaluate clinically relevant outcomes, is feasible. Methods: This single-centre, blinded, placebo-controlled, randomized feasibility trial included patients with acute kidney injury who started SLED in the ICU. Patients were randomized to receive 25% albumin versus 0.9% saline (control) as 100 mL boluses at the start and midway through SLED, for up to 10 sessions. The recruitment rate and other feasibility outcomes were determined. Secondary exploratory outcomes included ultrafiltration volumes and metrics of hemodynamic instability.Results: Sixty patients (271 SLED sessions) were recruited over 10 months. Age and severity of illness were similar between study groups. Most had septic shock and required vasopressor support at baseline. Protocol adherence occurred for 244 sessions (90%); no patients were lost to follow-up; no study-related adverse events were observed; open label albumin use was 9% and 15% in the albumin and saline arms, respectively. Ultrafiltration volumes were not significantly different but, compared to the saline group, the albumin group experienced less hemodynamic instability across all definitions assessed including a smaller absolute decrease in systolic blood pressure (mean difference 10.0 mmHg, 95% confidence interval 5.2 - 14.8).Conclusions: SLED patients who received intravenous 25% albumin during treatments experienced less hemodynamic instability than those who received 0.9% saline. A larger trial to evaluate clinically relevant outcomes is feasible.Trial Registration: ClinicalTrials.gov (NCT03665311); First Posted: Sept 11th, 2018. https://clinicaltrials.gov/ct2/show/NCT03665311?term=NCT03665311&draw=2&rank=1

scholarly journals Patterns of AKI Patients Requiring Sustained Low Efficiency Dialysis (SLED) Admitted in an ICU of Bangladesh

2015 ◽  
Vol 2 (2) ◽  
pp. 68-70
Author(s):  
Kaniz Fatema ◽  
Mohammad Omar Faruq ◽  
ASM Areef Ahsan ◽  
Fatema Ahmed
Keyword(s):  
Acute Kidney Injury ◽  
De Novo ◽  
Kidney Injury ◽  
Severity Of Illness ◽  
Hemodynamic Instability ◽  
Acute Kidney Injury Network ◽  
Apache Ii ◽  
Apache Ii Score ◽  
Chronic Renal Impairment ◽  
Low Efficiency

Background: Acute kidney injury (AKI) is a common and serious complication among patients admitted in intensive care units (ICUs). The incidence, cause, severity and outcome of AKI in Bangladeshi ICUs is largely unknown. The aim of this study was to find out the cause of AKI among the hemodynamically unstable patients requiring SLED admitted to the ICU of BIRDEM Hospital, Dhaka, Bangladesh.Methods: All critically ill patients of AKI admitted to the 10 bed mixed adult ICU over a period of a year were studied prospectively if they needed SLED. Standard demographic, physiologic and clinical data were collected. Severity of illness was assessed using acute physiology and chronic health evaluation (APACHE) II score. Diagnosis of AKI was based on Acute Kidney Injury Network (AKIN) criteria.Results: 43 hemodynamically unstable patients with AKI were studied. Mean age of the patients were 60.12 ± 14.57 with 67.4% male patients. 35% patients had de novo AKI where as 65% had acute on chronic renal failure. There was high prevalence of DM (72.1%) and HTN (60.5%) among study patients. Septic shock (48.83%) and cardiac cause including acute myocardial infarction and/or cardiogenic shock (46.51%) were the two commonest causes of AKI in our ICU.Conclusion: Higher age, pre-existing chronic renal impairment, DM and HTN were associated with AKI with hemodynamic instability requiring SLED. Sepsis is the commonest cause of AKI followed by cardiac causes. As expected, sicker patients with high APACHE II score were more likely to develop AKI. However, a larger scale study should be done including all hemodynamically unstable AKI patients admitted in different ICUs of BangladeshBangladesh Crit Care J September 2014; 2 (2): 68-70

scholarly journals Principles of Drug Dosing in Sustained Low Efficiency Dialysis (SLED) and Review of Antimicrobial Dosing Literature

Pharmacy ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 33
Author(s):  
Paula Brown ◽  
Marisa Battistella
Keyword(s):  
Acute Kidney Injury ◽  
Renal Replacement Therapy ◽  
Critically Ill Patients ◽  
Dose Adjustment ◽  
Kidney Injury ◽  
Hemodynamic Instability ◽  
Drug Dosing ◽  
Low Efficiency ◽  
Preliminary Recommendation ◽  
Selection Of

The use of sustained low-efficiency dialysis (SLED) as a renal replacement modality has increased in critically ill patients with both acute kidney injury (AKI) and hemodynamic instability. Unfortunately, there is a paucity of data regarding the appropriate dosing of medications for patients undergoing SLED. Dose adjustment in SLED often requires interpretation of pharmacodynamics and pharmacokinetic factors and extrapolation based on dosing recommendations from other modes of renal replacement therapy (RRT). This review summarizes published trials of antimicrobial dose adjustment in SLED and discusses pharmacokinetic considerations specific to medication dosing in SLED. Preliminary recommendation is provided on selection of appropriate dosing for medications where published literature is unavailable.

scholarly journals P0637SAFETY, EFFICACY AND OUTCOMES OF SLOW LOW EFFICIENCY DIALYSIS (SLED) IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY (AKI) IN MEDICAL INTENSIVE CARE UNITS (ICU)- A PROSPECTIVE STUDY IN A TERTIARY CARE HOSPITAL IN INDIA

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Reetesh Sharma ◽  
Mayur Maksana
Keyword(s):  
Acute Kidney Injury ◽  
Metabolic Acidosis ◽  
Prospective Study ◽  
Critically Ill ◽  
Sofa Score ◽  
Critically Ill Patients ◽  
Kidney Injury ◽  
Hemodynamic Instability ◽  
Medical Icus ◽  
Low Efficiency

Abstract Background and Aims Slow low efficiency dialysis (SLED) is increasingly being used as a renal replacement therapy in hemodynamically unstable, critically ill patients with acute kidney injury (AKI). SLED may reduce intradialytic hemodynamic instability as compared with conventional intermittent haemodialysis, while reducing resource demands of continuous renal replacement therapies (CRRT). There are very few studies which have evaluated its safety, efficacy and outcome despite its increasing use, especially in Indian subcontinent. Method We conducted a single centre, prospective study to demonstrate safety, efficacy and outcome of SLED.. Net fluid removal and duration of SLED were based on need and hemodynamic status of the individual patient as decided by treating nephrologist. SOFA score was used as severity illness score. Efficacy of SLED was studied in terms of ability to achieve ultrafiltration goal, correction of acidosis and urea reduction ratio. Safety was studied in terms of hemodynamic and cardiovascular stability and complications during and after SLED. Outcomes were noted at time of discharge and six months later in terms of dialysis dependence, renal parameters (if dialysis independent) and mortality (In hospital and 6 months following discharge). We included hemodynamically unstable patients with AKI from medical ICUs with age >18 years of either gender. We excluded patients with AKI who could tolerate conventional haemodialysis or ESRD on maintenance haemodialysis. Results We analysed 228 patients with AKI in medical ICUs who underwent 576 SLED sessions over period of six months. Mean age was 57.48 ± 15.67 years and 74% (n=169) were male. Comorbidities were hypertension (56%), diabetes mellitus (43%), CKD (33%) and cardiovascular diseases (28%). Sepsis (93%) and hypoperfusion (68%) were most common causes for AKI. Refractory fluid overload (91%) and refractory metabolic acidosis (79%) were most common indications for SLED. Mean SOFA score was 12.2 ± 7.75 with 61 % patients had SOFA score more than 11. 66% were on mechanical ventilator. Out of 576 sessions, 555 sessions (96%) completed the planned duration without any adverse event. Planned ultrafiltration goal was achieved in 94%. SLED was able to correct metabolic acidosis in majority (86.1%). 68% SLED sessions required a vasopressor support and 34.8 % of SLED sessions were associated with hemodynamic instability. Total 14(6.2 %) patients died during SLED session. No documented arrhythmias developed after starting SLED. In-hospital mortality occurred in 61% patients. At 6 months follow up, another 13% patients died. In subgroup analysis, mortality was significantly higher in patients with SOFA score more than 11 (P<0.0001). Ventilatory requirement was also significantly high in non-survivors(P<0.0001). Univariate logistic regression analysis showed that inotropic requirement, higher SOFA severity score, acidosis with pH <7.25 and presence of underlying CKD were associated with significant mortality. Conclusion Our study demonstrated efficacy and safety of SLED in critically ill AKI patients in medical ICU. SLED was able to achieve planned ultrafiltration goal and correct metabolic acidosis in majority of patients. SLED had good hemodynamic tolerability. Mortality was noted in 61 % of patients (not attributable to SLED per se). High SOFA score, underlying co morbidities, vasopressor requirement and severe acidosis (pH <7.25) were associated with high mortality. SLED is a reasonable cost-effective option of RRT in hemodynamically unstable patients with AKI especially in developing countries.

scholarly journals 0.9% saline V/S Ringer’s lactate for fluid resuscitation in adult sepsis patients in emergency medical services: An open-label randomized controlled trial

2020 ◽  
pp. 102490792094898
Author(s):  
Rithvik Golla ◽  
Susheel Kumar ◽  
Deba Prasad Dhibhar ◽  
Ashish Bhalla ◽  
Navneet Sharma
Keyword(s):  
Acute Kidney Injury ◽  
Hospital Stay ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Saline Group ◽  
P Value ◽  
Open Label ◽  
Randomized Controlled ◽  
Serum Chloride ◽  
Ringer’S Lactate

Background: 0.9% saline commonly used for resuscitation of septic patients might induce biochemical changes leading to detrimental effects. Ringer’s lactate being a balanced crystalloid might be beneficial in such a scenario. Objectives: We undertook this study to explore in detail the effect of these fluids in the resuscitation of septic patients, and risks and benefits these two fluids would have on the overall prognosis of patients. Methods: This was an open-label randomized controlled trial undertaken in emergency medical services attached to the department of medicine at a tertiary care teaching hospital. One hundred sixty adult (⩾18 years old) medical patients admitted with the diagnosis of sepsis fulfilling eligibility criteria were included. They were randomly assigned to receive 0.9% saline or ringer’s lactate. These fluids were given for the initial 24 h only, and after then, the type of fluid given was based on treating physician discretion. Various biochemical parameters were measured at baseline and various time points during the hospital stay. The primary outcome was to find out the incidence of hyperchloremia at 24 h from the time of randomization and during the hospital stay. The secondary outcomes were incidence of acute kidney injury, need for renal replacement therapy; differences in pH, bicarbonate, serum lactate, coagulation parameters, sequential organ failure assessment scores at various time points; and hospital/30-day mortality. Results: The baseline characteristics in both groups were comparable. At admission, each group had a serum chloride value which was comparable ( p value: 0.595); however, at 24 and 48 h, a statistically significant difference was noticed, with 0.9% saline group having a higher mean serum chloride value (113.66 ± 10.04 v/s 108.98 ± 8.04 mEq/L, p value: 0.001 at 24 h) and (114.75 ± 9.51 v/s 111.12 ± 7.84 mEq/L, p value: 0.022 at 48 h). At 24 and 48 h post-randomization, the incidence of hyperchloremia was significantly higher in the 0.9% saline group (at 24 h, 0.9% saline: 75.0% v/s Ringer’s lactate: 48.8%, p value: 0.001 and at 48 h, 0.9% saline: 77.2% v/s Ringer’s lactate: 60.3%, p value: 0.022), although there was no difference in the incidence of hyperchloremia recorded during the hospital stay. Acute kidney injury incidence at 24 and 48 h post-randomization was significantly higher in the 0.9% saline group (at 24 h, 0.9% saline: 23.8% v/s Ringer’s lactate: 10.0%, p value: 0.020 and at 48 h, 0.9% saline: 29.1% v/s Ringer’s lactate: 15.4%, p value: 0.039). No significant differences in other secondary outcomes were observed. Conclusion: Higher incidence of hyperchloremia and a higher rate of acute kidney injury at 24 and 48 h after randomization were noted in the 0.9% saline group.

scholarly journals Renal replacement treatment initiation with twice-weekly versus thrice-weekly haemodialysis in patients with incident dialysis-dependent kidney disease: rationale and design of the TWOPLUS pilot clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047596
Author(s):  
Mariana Murea ◽  
Shahriar Moossavi ◽  
Alison J Fletcher ◽  
Deanna N Jones ◽  
Hiba I Sheikh ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Pilot Trial ◽  
Urine Volume ◽  
Kidney Injury ◽  
Left Ventricular ◽  
Pharmacological Therapy ◽  
Recruitment Rate ◽  
Left Ventricular Ejection ◽  
Open Label ◽  
Ventricular Ejection Fraction

Introduction The optimal haemodialysis (HD) prescription—frequency and dose—for patients with incident dialysis-dependent kidney disease (DDKD) and substantial residual kidney function (RKF)—that is, renal urea clearance ≥2 mL/min/1.73 m2 and urine volume ≥500 mL/day—is not known. The aim of the present study is to test the feasibility and safety of a simple, reliable prescription of incremental HD in patients with incident DDKD and RKF. Methods and analysis This parallel-group, open-label randomised pilot trial will enrol 50 patients from 14 outpatient dialysis units. Participants will be randomised (1:1) to receive twice-weekly HD with adjuvant pharmacological therapy for 6 weeks followed by thrice-weekly HD (incremental HD group) or outright thrice-weekly HD (standard HD group). Age ≥18 years, chronic kidney disease progressing to DDKD and urine output ≥500 mL/day are key inclusion criteria; patients with left ventricular ejection fraction <30% and acute kidney injury requiring dialysis will be excluded. Adjuvant pharmacological therapy (ie, effective diuretic regimen, patiromer and sodium bicarbonate) will complement twice-weekly HD. The primary feasibility end points are recruitment rate, adherence to the assigned HD regimen, adherence to serial timed urine collections and treatment contamination. Incidence rate of clinically significant volume overload and metabolic imbalances in the first 3 months after randomisation will be used to assess intervention safety. Ethics and dissemination The study has been reviewed and approved by the Institutional Review Board of Wake Forest School of Medicine in North Carolina, USA. Patient recruitment began on 14 June 2019, was paused between 13 March 2020 and 31 May 2020 due to COVID-19 pandemic, resumed on 01 June 2020 and will last until the required sample size has been attained. Participants will be followed in usual care fashion for a minimum of 6 months from last individual enrolled. All regulations and measures of ethics and confidentiality are handled in accordance with the Declaration of Helsinki. Trial registration number NCT03740048; Pre-results.

Evaluating the Proposed Mechanism by Which Atorvastatin Can Protect Renal Tissue against Contrast Media: An Animal study

2019 ◽  
pp. 75-84
Keyword(s):  
Contrast Media ◽  
Kidney Injury ◽  
Saline Group ◽  
Pleiotropic Effect ◽  
Renal Tissue ◽  
Male Rats ◽  
Dependent Manner ◽  
Group 2 ◽  
Dose Dependent ◽  
Media Group

Contrast- induced nephropathy (CIN) is an elevation of serum creatinine of ≥ 0.5 mg/dL from baseline after two to three days of exposure to contrast substance if there is no other cause for acute kidney injury. Atorvastatin may protect normal kidney physiology from contrast- induced kidney injury by effects unrelated to hypolipidemia termed pleiotropic effect by decline of endothelin production, angiotensin system down regulation, and under expression of endothelial adhesion molecules. This study was conducted to assess the strategy by which atorvastatin can achieve protective effect for kidneys after exposure to contrast media in an animal model. A 40 male rats were distributed randomly into 4 groups; ten rats for each: group (1): given normal saline; group (2): CIN group given iopromide as contrast media; group (3): given atorvastatin (20mg/kg) and iopromide; and group (4): given atorvastatin (40mg/kg) and iopromide. Blood collected by cardiac puncture for detection of serum glutathione, malondialdehyde, matrix metalloproteinase-9, and interleukin-18. The results have shown a significant increase in inflammatory and oxidative stress markers in contrast media group, and significant reduction in these markers in atorvastatin treated groups, in a dose-dependent manner. As conclusion, atorvastatin mechanism for protection against CIN in a dose-dependent manner can mediate by anti-inflammatory and antioxidant effects.

scholarly journals 71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Wrist Fracture ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Point Of Care Ultrasound ◽  
Distal Radial Fractures ◽  
Definitive Trial ◽  
Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

scholarly journals Intra-dialytic hypotension following the transition from continuous to intermittent renal replacement therapy

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
William Beaubien-Souligny ◽  
Yifan Yang ◽  
Karen E. A. Burns ◽  
Jan O. Friedrich ◽  
Alejandro Meraz-Muñoz ◽  
...  
Keyword(s):  
Renal Replacement Therapy ◽  
Hospital Mortality ◽  
Replacement Therapy ◽  
Kidney Injury ◽  
Hemodynamic Instability ◽  
Factors Associated ◽  
Definition Of ◽  
Vasopressor Use ◽  
Cumulative Fluid Balance ◽  
Intermittent Renal Replacement Therapy

Abstract Background Transition from continuous renal replacement therapy (CRRT) to intermittent renal replacement therapy (IRRT) can be associated with intra-dialytic hypotension (IDH) although data to inform the definition of IDH, its incidence and clinical implications, are lacking. We aimed to describe the incidence and factors associated with IDH during the first IRRT session following transition from CRRT and its association with hospital mortality. This was a retrospective single-center cohort study in patients with acute kidney injury for whom at least one CRRT-to-IRRT transition occurred while in intensive care. We assessed associations between multiple candidate definitions of IDH and hospital mortality. We then evaluated the factors associated with IDH. Results We evaluated 231 CRRT-to-IRRT transitions in 213 critically ill patients with AKI. Hospital mortality was 43.7% (n = 93). We defined IDH during the first IRRT session as 1) discontinuation of IRRT for hemodynamic instability; 2) any initiation or increase in vasopressor/inotropic agents or 3) a nadir systolic blood pressure of < 90 mmHg. IDH during the first IRRT session occurred in 50.2% of CRRT-to-IRRT transitions and was independently associated with hospital mortality (adjusted odds ratio [OR]: 2.71; CI 1.51–4.84, p < 0.001). Clinical variables at the time of CRRT discontinuation associated with IDH included vasopressor use, higher cumulative fluid balance, and lower urine output. Conclusions IDH events during CRRT-to-IRRT transition occurred in nearly half of patients and were independently associated with hospital mortality. We identified several characteristics that anticipate the development of IDH following the initiation of IRRT.

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