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.

MANAGEMENT OF HEART FAILURE PATIENTS (UPDATE 2019) – PHARMACOLOGICAL THERAPY

2020 ◽  
Vol 1 (54) ◽  
pp. 30-32
Author(s):  
Przemysław Mitkowski ◽  
Maciej Grymuza
Keyword(s):  
Heart Failure ◽  
Biventricular Pacing ◽  
Total Mortality ◽  
Cardiovascular Death ◽  
Left Ventricular ◽  
Pharmacological Therapy ◽  
Left Ventricular Ejection ◽  
Premature Ventricular Contractions ◽  
Ventricular Ejection Fraction ◽  
Patients With Heart Failure

The up-date of ESC Guidelines on the management of patients with heart failure was published last year. The beneficial effect of a new group of drugs (flozins, sacubitril/valsartan - ARNI) in patients with heart failure was pointed out. These drugs not only prevent the onset of heart failure but also reduce HF hospitalization rate and in patients with reduced left ventricular ejection fraction decrease risk of cardiovascular death and in case of empagliflozin, dapagliflozin or sacubitril/valsartan also total mortality. These latter medicines reduce also the likelihood of sudden cardiac death. ARNI reduce the number of appropriate ICD shocks, the incidence of non-sustained VT, premature ventricular contractions, and increase percentage of biventricular pacing in car­diac resynchronization recipients.

Abstract 13306: Combined Assessment of Acute Kidney Injury and Increased Plasma Concentration of D-dimer Is Useful for Evaluating 1-year Mortality in Patients Hospitalized to Coronary Care Units

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Shigeru Matsui ◽  
Junichi Ishii ◽  
Ryuunosuke Okuyama ◽  
Hiroshi Takahashi ◽  
Hideki Kawai ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Relative Risk ◽  
Kidney Injury ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Absolute Increase ◽  
Ventricular Ejection Fraction ◽  
Coronary Syndrome ◽  
Coronary Care ◽  
D Dimer

Background: Acute kidney injury (AKI) detected after admission to coronary care unit (CCU) is associated with very poor outcomes. We prospectively investigated the prognostic value of a combination of AKI and high plasma D-dimer levels for 1-year mortality in patients hospitalized to CCUs. Methods: D-dimer, N-terminal pro-B-type natriuretic peptide (NT-proBNP), and high-sensitive C-reactive protein (hsCRP) levels were measured in 1228 patients on admission to CCUs, of whom 56% had decompensated heart failure and 38% had acute coronary syndrome. AKI was defined as an increase of >25% in creatinine from baseline or an absolute increase of ≥0.5 mg/dL within 48 h after admission. Left ventricular ejection fraction (LVEF) and E/e’ ratio were estimated using echocardiography with tissue Doppler imaging. Results: AKI was detected in 163 (13%) patients. During 1-year follow-up period, there were 149 (12%) deaths. The patients who died were older (median: 77 vs. 73 years; p < 0.0001) and exhibited higher D-dimer (2.7 vs. 1.3 μg/mL; p < 0.0001), NT-proBNP (5495 vs. 1525 pg/mL; p < 0.0001), and hsCRP levels (0.92 vs, 0.26 mg/L; p < 0.0001) and E/e’ ratio (15.0 vs. 13.2; p = 0.006). They also had a higher incidence of AKI (26% vs. 12%; p < 0.0001) and lower LVEF (39% vs. 49%; p < 0.0001) and estimated glomerular filtration rate (45 vs. 62 mL/min/1.73 m 2 ; p < 0.0001) than patients who survived. Multivariate Cox regression analysis, including 12 clinical, biochemical, and echocardiographic variables, identified AKI (relative risk: 1.79; p = 0.008) and increased D-dimer level (relative risk: 1.83 per 10-fold increment; p = 0.002) as independent predictors of 1-yeart mortality. The combined assessment of AKI and D-dimer quartiles was significantly associated with 1-year mortality rates (Figure). Conclusions: The combined assessment of AKI and high D-dimer levels may be useful for evaluating the risk of 1-year mortality in patients admitted to CCUs.

scholarly journals A novel nomogram to predict perioperative acute kidney injury following isolated coronary artery bypass grafting surgery with impaired left ventricular ejection fraction

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Hongyuan Lin ◽  
Jianfeng Hou ◽  
Hanwei Tang ◽  
Kai Chen ◽  
Hansong Sun ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Artery Bypass ◽  
Kidney Injury ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
The Novel ◽  
Net Benefit ◽  
Ventricular Ejection Fraction ◽  
Derivation Cohort ◽  
Postoperative Aki

Abstract Background and objective Heart failure (HF) is a global health issue, and coronary artery bypass graft (CABG) is one of the most effective surgical treatments for HF with coronary artery disease. Unfortunately, the incidence of postoperative acute kidney injury (AKI) is high in HF patients following CABG, and there are few tools to predict AKI after CABG surgery for such patients. The aim of this study is to establish a nomogram to predict the incidence of AKI after CABG in patients with impaired left ventricular ejection fraction (LVEF). Methods From 2012 to 2017, Clinical information of 1208 consecutive patients who had LVEF< 50% and underwent isolated CABG was collected to establish a derivation cohort. A novel nomogram was developed using the logistic regression model to predict postoperative AKI among these patients. According to the same inclusion criteria and the same period, we extracted the data of patients from 6 other large cardiac centers in China (n = 540) from the China Heart Failure Surgery Registry (China-HFSR) database for external validation of the new model. The nomogram was compared with 3 other available models predicting renal failure after cardiac surgery in terms of calibration, discrimination and net benefit. Results In the derivation cohort (n = 1208), 90 (7.45%) patients were diagnosed with postoperative AKI. The nomogram included 7 independent risk factors: female, increased preoperative creatinine(> 2 mg/dL), LVEF< 35%, previous myocardial infarction (MI), hypertension, cardiopulmonary bypass(CPB) used and perioperative blood transfusion. The area under the receiver operating characteristic curve (AUC) was 0.738, higher than the other 3 models. By comparing calibration curves and decision curve analyses (DCA) with other models, the novel nomogram showed better calibration and greater net benefit. Among the 540 patients in the validation cohort, 104 (19.3%) had postoperative AKI, and the novel nomogram performed better with respect to calibration, discrimination and net benefit. Conclusions The novel nomogram is a reliable model to predict postoperative AKI following isolated CABG for patients with impaired LVEF.

Contrast induced acute kidney injury prevention during angiographic procedure with early renal replacement therapy

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Gritti ◽  
S Pierini ◽  
M Ornaghi ◽  
A Paggi ◽  
I Baragetti ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Renal Replacement Therapy ◽  
Contrast Media ◽  
Replacement Therapy ◽  
Kidney Injury ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
P Value ◽  
Shock Onset ◽  
Ventricular Ejection Fraction

Abstract Background and purpose Post-angiography renal replacement therapy (RRT) has shown protective effects from Ci-AKI (contrast induced acute kidney injury) in patients with pre-existing advanced renal disfunction. We analysed a series of 1095 continuative patients who undergone coronary or peripheral angiography in our center. In non-haemodialyzed patients with eGFR &lt;20ml/min/1.73m2 or with poor renal reserve we performed an “early” RRT, starting during angiography procedure and applied for at least 6 h after procedure, thus diverging from previous literature data based only on post-procedure hours delayed RRT application. The RRT modality chosen was CVVHDF (continous veno-venous hemodiafiltration). Methods We considered following subjects variability: age, sex, weight, presence of hypertension, dyslipidaemia, diabetes, smoking habitude, left ventricular ejection fraction, amount of contrast media given and shock or infection occurrence during hospital stay. We evaluate statistic significative of serum creatine (SCr) variation in patients receiving RRT from pre-procedure time (T0), at 24h (T1), 48h (T2), 72h (T3) after procedure and at 3–8 weeks follow-up (T4). Quantitative data were compared with Student T test, qualitative data with Chi Square test, considering statistically significant p value &lt;0.05 with two tails. Ci-AKI was defined as serum creatinine rise ≥0.3 mg/dL at 48h from contrast media administration, following KDIGO (kidney disease improving global outcomes) guidelines definition. Results 26 patients received RRT. Medium SCr at T0 was 3.37 mg/dl and showed a significative reduction (see figure) at T1 (−0.88mg/dl = −20.6%, p=0.003) and T2 (−0.96mg/dl = −18.33%, p=0.029) and a trend towards reduction at T3 (−0.78mg/dl, p=0.174) and at T4 (−0.28mg/dl, p=0.568). Between 26 pts, 6 pts (23%) developed Ci-AKI. Only contrast media amount significatively diverge between two groups (183 ml in the group with Ci-AKI vs 162 ml in pts with no Ci-AKI, p=0.03), showing also a trend towards significance for infection occurrence (83.3% pts Ci-AKI vs 40% pts no Ci-AKI, p=0.06) and shock onset (33.3%pts Ci-AKI vs 5% pts no Ci-AKI, p=0.06). Average SCr diverge at T2 (3.18mg/dl Ci-AKI vs 2.04mg/dl no Ci-AKI, p=0.01) and at T3 (3.33mg/dl CI-AKI vs 2.31mg/dl no CI-AKI, p=0.06); we also found a trend towards progressive increase of SCr for Ci-AKI pts (T0-T1: +0.17mg/dl, p=ns; T0-T2: +0.41mg/dl, p=ns; T0-T3: +0.57mg/dl, p=ns; T0-T4: +1.35mg/dl, p=ns) and a significative reduction in SCr for no Ci-AKI pts (T0-T1: −1.23mg/dl = −29.32% p=0.001; T0-T2: −1.46mg/dl = −30.78%, p=0.01; T0-T4: −0.41mg/dl = −15.5%, p=0.05). Conclusions Early RRT with CVVHDF modality results effective in 77% of patients in avoiding Ci-AKI, with a significative SCr reduction at 24 and 48h. An increased amount of contrast media is significatively related to Ci-AKI incidence. Ci-AKI development could also possibly be related to shock and infection occurrence. Figure 1 Funding Acknowledgement Type of funding source: None

Phase II study evaluating the association of gemcitabine, trastuzumab, and erlotinib as first-line treatment in patients with metastatic pancreatic adenocarcinoma (GATE 1).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 379-379 ◽  
Author(s):  
Eric Assenat ◽  
Laurent Mineur ◽  
Caroline Mollevi ◽  
Catherine Lombard-Bohas ◽  
Thibault Mazard ◽  
...  
Keyword(s):  
Performance Status ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Ventricular Ejection Fraction ◽  
Secondary Endpoints ◽  
Grade 3 ◽  
First Line Treatment

379 Background: This study aimed to assess the efficacy and tolerance of the combinationof chemotherapy and two targeted therapies as a first-line treatment in metastatic pancreatic cancer patients. Methods: We designed a phase 2 open-label, non-comparative, multicenter study (NCT01204372). Patients received weekly 1000 mg/m² gemcitabine (3 weeks out of 4), weekly trastuzumab (4 mg/kg the first week, 2 mg/kg afterwards) and erlotinib 100 mg/day per os. The primary endpoint was the disease control rate (DCR) according to RECIST. Using a Fleming’s single-stage procedure, the trial was considered positive if 29 patients had a controlled disease (out of 57 evaluable patients). Secondary endpoints included the safety, the progression-free survival (PFS) and the overall survival (OS). An ancillary study addressed the EGFR, HER2 and KRAS status of the patients. Results: Between June 2010 and July 2013, 62 patients were recruited (37 men). The median age was 62 years (range 35-77). Performance status was 0 (n=27) and 1 (n=35). 10 patients had had a surgery of the primary tumor (PT), of whom 6 had been treated with a gemcitabine-based adjuvant chemotherapy (> 6-month delay). PT were localized in the head (n=25), corpus (n=22) and tail (n=15) of pancreas. The number of metastatic sites varied from 1 (n=25) to ≥ 3 (n=15). The baseline median left ventricular ejection fraction was 65% (range 51-86%). All patients were evaluable for safety and 59 patients for efficacy. Main first cycle treatment-related toxicities included: grade 3 anorexia (27%), asthenia (13%), diarrhea (10%), anemia (6%), and thrombocytopenia (3%); grade 3-4 neutropenia (24%), and mucositis (6%); grade 2-3 cutaneous events (35%). No complete responses were observed. 11 patients had a partial response, 33 a stable disease and 15 a disease progression. Therefore, the DCR was 74.6% (95%CI: 61.6-85.0%). Definitive results for the secondary endpoints will be presented at the meeting. Conclusions: Our results showed that combining gemcitabine, trastuzumab and erlotinib is efficient in terms of DCR. A further study is necessary to investigate this promising association. Funding (Roche SAS). Clinical trial information: NCT01204372.

scholarly journals Prevention of kidney injury after myocardial ischemia reperfusion is achievable with short-term protein restriction

2019 ◽  
Vol 8 (4) ◽  
pp. 301-305
Author(s):  
Baran Hashemi ◽  
Majid Maleki ◽  
Amir Darbandi Azar ◽  
Morteza Zare ◽  
Seyed Mohammad Mazloomi ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Reperfusion Injury ◽  
Kidney Injury ◽  
Left Ventricular ◽  
Myocardial Reperfusion ◽  
Protein Restriction ◽  
Myocardial Reperfusion Injury ◽  
Left Ventricular Ejection ◽  
Short Term ◽  
Ventricular Ejection Fraction

Introduction: Kidney injury is a serious complication after cardiovascular surgery. Left ventricular dysfunction, pre-operative kidney dysfunction and inflammation can predict kidney injury after myocardial reperfusion. Objectives: We aimed to study whether short-term protein restriction (PR) would influence blood urea nitrogen (BUN) levels after myocardial reperfusion injury. Materials and Methods: Male Wistar rats fed with either AIN-93M or AIN-93M protein restricted diet one week before myocardial reperfusion injury. After surgery, feeding continued with AIN-93M for 1 week. Results: BUN levels increased significantly compared to the pre-operative level in the control group (P=0.03) and decreased significantly in the protein-restricted group (P=0.01). Multivariate analysis showed that PR through its effect on blood glucose (β=1.2, 95% CI=0.1- 2.34), IL-6 (β=-2.22, 95% CI=-3.9–-0.54) and left ventricular ejection fraction (LVEF) (β=-1.21, 95% CI=-2.34- 0.09) was able to protect the kidney from myocardial reperfusion. Conclusion: Short-term PR through modulating pre-operative IL-6, post-operative blood glucose levels and LVEF could prevent kidney injury after myocardial reperfusion injury.

scholarly journals The risks and benefits of spironolactone use in heart failure with a reduced left ventricular ejection fraction and chronic kidney disease

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
O Obertynska
Keyword(s):  
Heart Failure ◽  
Chronic Kidney Disease ◽  
Left Ventricular Ejection Fraction ◽  
Kidney Disease ◽  
Ejection Fraction ◽  
Left Ventricular ◽  
Ventricular Ejection ◽  
Public Institution ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction

Abstract Purpose Mineralocorticoid receptor antagonists (MRAs) remain underused in cases of heart failure with a reduced left ventricular ejection fraction (HFrEF) and chronic kidney disease (CKD), largely due to the fear of inducing worsening of renal function (RF) and hyperkalemia (HK), particularly in combination with renin angiotensin inhibitors. The aim was to investigate the safety use of spironolactone (SP) in patients with HFrEF (ejection fraction &lt;40%) and CKD and determine predictors of worsening of RF and developing HK. Methods 208 patients with HFrEF (on top of standard therapy including ACE-I or an ARB) and CKD (baseline eGFR between 30 and 60 ml/min) were included in the study. The potassium (K) and creatinine (C) levels, plasma aldosterone (AS) and NT-proBNP were estimated at baseline and at week 12. After biochemical evaluation, 101 patients started on SP treatment with a median dose of 23 mg daily (titrated). K and RF were checked at weeks 1, 2, 4, 6, 8, 12. Results K and C levels increased significantly after start of SP: mean K levels increased from 4.47±0.59 to 5.23±0.57 mEq/l, (P&lt;0.01) and was dose dependent. After 12 weeks of treatment the incidence of severe HK (K+ ≥6.0 mmol/L) was &lt;5%, K 5.5–5.9 mmol/L occurred in 13 patients (13%) and it was predicted by baseline eGFR≤35 ml/min/1.73 m2. and K ≥5.0 mmol/L/. Subsequently, these patients required a prescription of K binders. Mean eGFR on SP decreased from 48.34±2.23 to 42.19±2.65 ml/min/1.73 m2 (P&lt;0.01) and a significant decrease in GFR was observed only during the first month (P &lt;0.01) with not significant increasing to 6 and 12 weeks after the start of SP. Five patients (5%) on SP experienced significant decline of RF result in withdrew SP. Age, NT-proBNP concentration &gt;1550 ng/L and eGFR ≤35 ml/min/1.73 m2 at baseline had modest discriminative powers for predicting decline of RF (0.456, P&lt;0.01; 0.542, P&lt;0.001; 0.712, P&lt;0.001; respectively). At baseline in patients with HFrEF was an inverse correlation between GFR and NT-proBNP level (r=−0.298, p&lt;0.001). The SP treatment resulted in significantly reduced NT-proBNP and AS (P&lt;0.01; P&lt;0.05 respectively). By linear regression analysis in SP group the eGFR was associated with NT-proBNP change (0.362, P&lt;0.05). Conclusion In patient with HFrEF and CKD the risk-benefit ratio of spironolactone with respect to renal failure appears favourable due to improvement of the neurohumoral profile. Although the renal disfunction and hyperkalemia on spironolactone are common: approximately 18% patients required the prescription of K binders and 5% required the withdrew SP duo to decline RF, the occurrence of hyperkalemia was predicted by baseline potassium level and eGFR. Age, higher level of NT-proBNP and eGFR were identified as potential predictors of worsening of RF. So, caution should be advised when using spironolactone in HFrEF with CKD and potassium of ≥5.0 mmol/L and eGFR ≤35 ml/min/1.73 m2 and NT-proBNP concentration &gt;1550 ng/L for safety reasons. FUNDunding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): National Medical University

Nephrocheck after cardiac surgery: Does it play a role in daily practice? A sequel of “Nephrocheck results should be corrected for dilution”

2019 ◽  
Vol 42 (11) ◽  
pp. 665-667 ◽  
Author(s):  
Camilla L’Acqua ◽  
Erminio Sisillo ◽  
Luca Salvi ◽  
Giovanni Introcaso ◽  
Maria Luisa Biondi
Keyword(s):  
Acute Kidney Injury ◽  
Cardiac Surgery ◽  
Kidney Injury ◽  
Daily Practice ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Inclusion Criteria ◽  
Ventricular Ejection Fraction ◽  
Cycle Arrest ◽  
Urine Creatinine

Acute kidney injury is a well-recognized complication after cardiac surgery and significantly affects morbidity and mortality. Although the mechanisms of acute kidney injury are not fully understood, Nephrocheck (Astute Medical, San Diego, CA, USA) is a meter for early detection of acute kidney injury based on bedside urinalysis of two cell-cycle arrest biomarkers. However, considerable overlap in the AKIRiskTM score of different RIFLE groups makes interpretation of the score uncertain. A possible reason for the overlap in the AKIRisk score between different RIFLE groups could be that the score is not corrected for dilution. We performed a pilot study to explore the applicability of the test in our daily practice. A total of 68 patients electively scheduled for cardiac surgery with at least two of the following inclusion criteria: age > 70 years, glomerular filtration rate <60 mL/min, left ventricular ejection fraction <41%, redo procedure and combined procedures have been enrolled in the study, and 25 of them developed acute kidney injury. We described the correlation between urine creatinine and Nephrocheck, all the samples with low Nephrocheck (<0.2) also have low urine creatinine, less than 50 mg/dL, detecting a potential diluted sample. In conclusion, in our daily practice AKIRisk score, together with an assessment of whether urine is diluted or concentrated can better discriminate between various degrees of acute kidney injury.

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