The Effect in Renal Function and Vascular Decongestion in Type 1 Cardiorenal Syndrome Treated with Two Strategies of Diuretics, a Pilot Randomized Trial

Abstract Aim The main treatment strategy in type 1 cardiorenal syndrome (CRS1) is vascular decongestion. It is probable that sequential blockage of the renal tubule with combined diuretics (CD) will obtain similar benefits compared with stepped-dose furosemide (SF). Methods In a pilot double-blind randomized controlled trial of CRS1 patients were allocated in a 1:1 fashion to SF or CD. The SF group received a continuous infusion of furosemide 100 mg during the first day, with daily incremental doses to 200 mg, 300 mg and 400 mg. The CD group received a combination of diuretics, including 4 consecutive days of oral chlorthalidone 50 mg, spironolactone 50 mg and infusion of furosemide 100 mg. The objectives were to assess renal function recovery and variables associated with vascular decongestion. Results From July 2017 to February 2020, 80 patients were randomized, 40 to the SF and 40 to the CD group. Groups were similar at baseline and had several very high-risk features. Their mean age was 59 ± 14.5 years, there were 37 men (46.2%). The primary endpoint occurred in 20% of the SF group and 15.2% of the DC group (p = 0.49). All secondary and exploratory endpoints were similar between groups. Adverse events occurred frequently (85%) with no differences between groups (p = 0.53). Conclusion In patients with CRS1 and a high risk of resistance to diuretics, the use of CD compared to SF offers the same results in renal recovery, diuresis, vascular decongestion and adverse events, and it can be considered an alternative treatment. ClinicalTrials.gov with number NCT04393493 on 19/05/2020 retrospectively registered.

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The Effect in Renal Function and Vascular Decongestion in Type 1 Cardiorenal Syndrome Treated with Two Strategies of Diuretics, a Randomized Trial

10.21203/rs.3.rs-788038/v1 ◽

2021 ◽

Author(s):

Jonathan S. Chávez-Iñiguez ◽

Miguel Ibarra-Estrada ◽

Sergio Sánchez-Villaseca ◽

Gregorio Romero-González ◽

Jorge J. Font-Yañez ◽

...

Keyword(s):

Renal Function ◽

High Risk ◽

Adverse Events ◽

Controlled Trial ◽

Cardiorenal Syndrome ◽

Double Blind ◽

Renal Function Recovery ◽

Function Recovery ◽

Resistance To Diuretics

Abstract Aim:The main treatment strategy in type 1 cardiorenal syndrome (CRS1) is vascular decongestion. It is probable that sequential blockage of the renal tubule with combined diuretics (CD) will obtain similar benefits compared with stepped-dose furosemide (SF).Methods: In a double-blind randomized controlled trial of CRS1 patients were allocated in a 1:1 fashion to SF or CD. The SF group received a continuous infusion of furosemide 100 mg during the first day, with daily incremental doses to 200 mg, 300 mg and 400 mg. The CD group received a combination of diuretics, including 4 consecutive days of oral chlorthalidone 50 mg, spironolactone 50 mg and infusion of furosemide 100 mg. The objectives were to assess renal function recovery and variables associated with vascular decongestion.Results:From July 2017 to February 2020, 80 patients were randomized, 40 to the SF and 40 to the CD group. Groups were similar at baseline and had several very high-risk features. Their mean age was 59 ± 14.5 years, there were 37 men (46.2%). The primary endpoint occurred in 20% of the SF group and 15.2% of the DC group (p= 0.49). All secondary and exploratory endpoints were similar between groups. Adverse events occurred frequently (85%) with no differences between groups (p = 0.53).ConclusionIn patients with SCR-1 and a high risk of resistance to diuretics, the use of CD compared to SF offers the same results of renal recovery, diuresis, vascular decongestion and adverse events, and it can be considered an alternative treatment. ClinicalTrials.gov with number NCT04393493 in June 2017 retrospectively registered.

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A Randomized, Double-Blind, Placebo-Controlled Trial (TAURCAT Study) of Citrate Lock Solution for Prevention of Endoluminal Central Venous Catheter Infection in Neutropenic Hematological Patients

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01521-19 ◽

2019 ◽

Vol 64 (2) ◽

Author(s):

Carlota Gudiol ◽

Montserrat Arnan ◽

Manuela Aguilar-Guisado ◽

Cristina Royo-Cebrecos ◽

Isabel Sánchez-Ortega ◽

...

Keyword(s):

High Risk ◽

Adverse Events ◽

Bacterial Colonization ◽

Controlled Trial ◽

Case Fatality ◽

Central Venous ◽

Double Blind ◽

Hematological Patients ◽

Lock Solution ◽

Secondary Endpoints

ABSTRACT Infection of long-term central venous catheters (CVCs) remains a challenge in the clinical management of cancer patients. We aimed to determine whether a lock solution with taurolidine-citrate-heparin would be more effective than placebo for preventing nontunneled CVC infection in high-risk neutropenic hematologic patients. We performed a prospective, multicenter, randomized (1:1), double-blind, parallel, superiority, placebo-controlled trial involving 150 hematological patients with neutropenia carrying nontunneled CVCs who were assigned to receive CVC lock solution with taurolidine-citrate-heparin or heparin alone. The primary endpoint was bacterial colonization of the CVC hubs. Secondary endpoints were the incidence of catheter-related bloodstream infection (CRBSI), CVC removal, adverse events related to the lock solution, and the 30-day case fatality rate. CVC lock solution with taurolidine-citrate-heparin was associated with less colonization of the CVC hubs than that with placebo, with no statistically significant differences: 4.1%, versus 10.1% (relative risk [RR] = 0.41, 95% confidence interval [CI] = 0.11 to 1.52), with a cumulative incidence of 4.17 (95% CI = 0.87 to 11.70) and 10.14 (95% CI = 4.18 to 19.79), respectively. There were no significant differences regarding the secondary endpoints. Only three episodes of CRBSI occurred during the study period. No adverse events related to the administration of the lock solution occurred. In this trial involving high-risk patients carrying nontunneled CVCs, the use of taurolidine-citrate-heparin did not show a benefit over the use of placebo. Nevertheless, the safety of this prevention strategy and the trend toward less hub colonization in the taurolidine-citrate-heparin group raise the interest in assessing its efficacy in centers with higher rates of CRBSI. (This study has been registered in ISRCTN under identifier ISRCTN47102251.)

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Faculty Opinions recommendation of Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718206879.793509584 ◽

2015 ◽

Author(s):

Pagona Lagiou

Keyword(s):

Breast Cancer ◽

High Risk ◽

Postmenopausal Women ◽

Controlled Trial ◽

Double Blind ◽

Prevention Of Breast Cancer

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Faculty Opinions recommendation of MSG-01: A randomized, double-blind, placebo-controlled trial of caspofungin prophylaxis followed by preemptive therapy for invasive candidiasis in high-risk adults in the critical care setting.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718281739.793502937 ◽

2015 ◽

Author(s):

Jean-Francois Timsit

Keyword(s):

Critical Care ◽

High Risk ◽

Invasive Candidiasis ◽

Care Setting ◽

Controlled Trial ◽

Critical Care Setting ◽

Preemptive Therapy ◽

Double Blind ◽

Double Blind Placebo

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Faculty Opinions recommendation of Inhalational versus Intravenous Induction of Anesthesia in Children with a High Risk of Perioperative Respiratory Adverse Events: A Randomized Controlled Trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.732786749.793554105 ◽

2018 ◽

Author(s):

Yoshinori Nakata

Keyword(s):

Randomized Controlled Trial ◽

High Risk ◽

Adverse Events ◽

Controlled Trial ◽

Randomized Controlled

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Faculty Opinions recommendation of Efficacy of Atorvastatin in Prevention of Contrast-induced Nephropathy in High-risk Patients Undergoing Angiography: A Double-blind Randomized Controlled Trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.735810391.793560626 ◽

2019 ◽

Author(s):

Eric Hoste

Keyword(s):

Randomized Controlled Trial ◽

High Risk ◽

Controlled Trial ◽

Contrast Induced Nephropathy ◽

Double Blind ◽

High Risk Patients ◽

Randomized Controlled ◽

Risk Patients

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A Randomized Controlled Trial of Isoniazid to Prevent Mycobacterium tuberculosis Infection in Kenyan Human Immunodeficiency Virus–Exposed Uninfected Infants

Clinical Infectious Diseases ◽

10.1093/cid/ciaa827 ◽

2020 ◽

Cited By ~ 1

Author(s):

Sylvia M LaCourse ◽

Barbra A Richardson ◽

John Kinuthia ◽

A J Warr ◽

Elizabeth Maleche-Obimbo ◽

...

Keyword(s):

Human Immunodeficiency Virus ◽

Mycobacterium Tuberculosis ◽

High Risk ◽

Adverse Events ◽

Controlled Trial ◽

Preventive Therapy ◽

Infection Prevalence ◽

Mycobacterium Tuberculosis Infection ◽

Immunodeficiency Virus ◽

Exposed Uninfected

Abstract Background Human immunodeficiency virus (HIV)–exposed uninfected (HEU) infants in endemic settings are at high risk of tuberculosis (TB). For infants, progression from primary Mycobacterium tuberculosis (Mtb) infection to TB disease can be rapid. We assessed whether isoniazid (INH) prevents primary Mtb infection. Methods We conducted a randomized nonblinded controlled trial enrolling HEU infants 6 weeks of age without known TB exposure in Kenya. Participants were randomized (1:1) to 12 months of daily INH (10 mg/kg) vs no INH. Primary endpoint was Mtb infection at end of 12 months, assessed by interferon-γ release assay (QuantiFERON-TB Gold Plus) and/or tuberculin skin test (TST, added 6 months after first participant exit). Results Between 15 August 2016 and 6 June 2018, 416 infants were screened, with 300 (72%) randomized to INH or no INH (150 per arm); 2 were excluded due to HIV infection. Among 298 randomized HEU infants, 12-month retention was 96.3% (287/298), and 88.9% (265/298) had primary outcome data. Mtb infection prevalence at 12-month follow-up was 10.6% (28/265); 7.6% (10/132) in the INH arm and 13.5% (18/133) in the no INH arm (7.0 vs 13.4 per 100 person-years; hazard ratio, 0.53 [95% confidence interval {CI}, .24–1.14]; P = .11]), and driven primarily by TST positivity (8.6% [8/93] in INH and 18.1% [17/94] in no INH; relative risk, 0.48 [95% CI, .22–1.05]; P = .07). Frequency of severe adverse events was similar between arms (INH, 14.0% [21/150] vs no INH, 10.7% [16/150]; P = .38), with no INH-related adverse events. Conclusions Further studies evaluating TB preventive therapy to prevent or delay primary Mtb infection in HEU and other high-risk infants are warranted. Clinical Trials Registration NCT02613169.

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Atorvastatin is unlikely to prevent rheumatoid arthritis in high risk individuals: results from the prematurely stopped STAtins to Prevent Rheumatoid Arthritis (STAPRA) trial

RMD Open ◽

10.1136/rmdopen-2021-001591 ◽

2021 ◽

Vol 7 (1) ◽

pp. e001591

Author(s):

Laurette van Boheemen ◽

Samina Turk ◽

Marian van Beers-Tas ◽

Wouter Bos ◽

Diane Marsman ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

High Risk ◽

Cox Regression ◽

Controlled Trial ◽

Pharmacological Intervention ◽

Trial Participation ◽

Double Blind ◽

Cox Regression Analysis ◽

Atorvastatin Group ◽

Clinical Arthritis

ObjectivesPersons at high risk of rheumatoid arthritis (RA) might benefit from a low-risk pharmacological intervention aimed at primary prevention. Previous studies demonstrated disease-modifying effects of statins in patients with RA as well as an association between statin use and a decreased risk of RA development. A randomised, double-blind, placebo-controlled trial investigated whether atorvastatin could prevent arthritis development in high-risk individuals.MethodsArthralgia patients with anticitrullinated protein antibody (ACPA) >3 xULN or ACPA and rheumatoid factor, without (a history of) arthritis, were randomised to receive atorvastatin 40 mg daily or placebo for 3 years. The calculated sample size was 220 participants. The primary endpoint was clinical arthritis. Cox regression analysis was used to determine the effect of atorvastatin on arthritis development.ResultsDue to a low inclusion rate, mainly because of an unwillingness to participate, the trial was prematurely stopped. Data of the 62 randomised individuals were analysed. Median follow-up was 14 (inner quartiles 6–35) months. Fifteen individuals (24%) developed arthritis: 9/31 (29%) in the atorvastatin group; 6/31 (19%) in the placebo group: HR 1.40, 95% CI 0.50 to 3.95.ConclusionsIn this small set of randomised high-risk individuals, we did not demonstrate a protective effect of atorvastatin on arthritis development. The main reason for the low inclusion was unwillingness to participate; this may also impede other RA prevention trials. Further research to investigate and solve barriers for prevention trial participation is needed.

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Secondary Oxalate Nephropathy: Causes and Clinicopathological Characteristics of a Case Series

Nephron ◽

10.1159/000517072 ◽

2021 ◽

pp. 1-8

Author(s):

Shaoshan Liang ◽

Lijuan Li ◽

Dacheng Chen ◽

Dandan Liang ◽

Feng Xu ◽

...

Keyword(s):

Renal Function ◽

Renal Replacement Therapy ◽

Renal Biopsy ◽

Replacement Therapy ◽

Case Series ◽

Common Cause ◽

Renal Function Recovery ◽

Function Recovery ◽

Renal Biopsies ◽

Oxalate Nephropathy

Introduction: Secondary oxalate nephropathy (OxN) is associated with a variety of causes and has not been well characterized in Chinese population. To investigate the etiology, clinicopathological features, and outcomes of secondary OxN, we report a case series from a single center in China. Methods: A retrospective analysis of 68 patients diagnosed with secondary OxN by renal biopsy from January 2013 to February 2019 in Jinling Hospital was performed. Results: Secondary OxN accounted for 0.23% of the renal biopsies and 2.31% of patients who received renal biopsies due to acute kidney injury (AKI). A total of 49 men and 19 women with an average age of 51.6 ± 11.8 years were enrolled. The most common cause was iatrogenic medication, followed by oxalate-rich diet and industry exposure. Stage 1, 2, and 3 AKI and AKI on chronic kidney disease (ACKD) were found in 4.4, 8.8, 69.1, and 17.6% of the patients, respectively. The peak serum creatinine during hospitalization was 8.62 ± 4.67 mg/dL. The median urinary oxalate excretion was 51.5 (23.2–147.1) mg/24 h. Kidney biopsy showed extensive calcium oxalate crystal deposits with acute tubulointerstitial nephritis. Thirty-four patients (50.0%) required renal replacement therapy. At the end of a follow-up that lasted 8.7 (0.1–72.1) months, 81.0% of patients achieved renal function recovery in 50 (14–432) days. Patients with renal function recovery had a lower rate of ACKD, a higher level of hemoglobin, a lower level of urine lysozyme, and a lower degree of interstitial fibrosis/tubular atrophy, interstitial inflammation, and global glomerulosclerosis than those in the nonrecovery group. Conclusions: In this case series of secondary OxN, the most common cause was iatrogenic medication, and it presented with AKI or ACKD. Half of the patients required renal replacement therapy, and in most of them, the renal function was reversible. Renal biopsy played an important role in diagnosis and prognosis evaluation.

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