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Randomized Trials

RCT: Convalescent plasma does not improve outcomes and may be harmful to hospitalized patients with COVID-19.

10 Sep, 2021 | 05:37h | UTC

Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial – Nature Medicine

News release: Major study finds convalescent plasma doesn’t help seriously ill COVID-19 patients – McMaster University

Related:

NIH study shows no significant benefit of convalescent plasma for COVID-19 outpatients with early symptoms.

M-A: Convalescent plasma is safe but does not improve outcomes in the treatment of COVID-19.

RECOVERY Trial: No benefit from convalescent plasma in patients admitted to hospital with COVID-19.

 

Commentary on Twitter

 

RCT: In patients undergoing major surgery, targeting light anesthesia reduced the risk of postoperative delirium and cognitive impairment at one year.

10 Sep, 2021 | 05:19h | UTC

Anaesthetic depth and delirium after major surgery: a randomised clinical trial – British Journal of Anaesthesia (link to abstract – $ for full-text)

 

[Preprint] RCT: Additional heterologous vs. homologous booster vaccination in immunosuppressed patients without SARS-CoV-2 antibody seroconversion after primary mRNA vaccination.

9 Sep, 2021 | 09:55h | UTC

Additional heterologous versus homologous booster vaccination in immunosuppressed patients without SARS-CoV-2 antibody seroconversion after primary mRNA vaccination: a randomized controlled trial – medRxiv

 

Commentary on Twitter (thread – click for more)

https://twitter.com/hildabast/status/1435720202147143680

 

RCT: A Seven-days course of antibiotics for the treatment of bloodstream infections by Enterobacterales was noninferior to a 14-days course.

9 Sep, 2021 | 09:03h | UTC

Seven versus 14-days course of antibiotics for the treatment of bloodstream infections by Enterobacterales. A randomized, controlled trial – Clinical Microbiology and Infection

 

Commentary on Twitter

 

RCT: No benefit from Cyclophosphamide added to glucocorticoids in acute exacerbation of idiopathic pulmonary fibrosis.

9 Sep, 2021 | 08:59h | UTC

Cyclophosphamide added to glucocorticoids in acute exacerbation of idiopathic pulmonary fibrosis (EXAFIP): a randomised, double-blind, placebo-controlled, phase 3 trial – The Lancet Respiratory Medicine (link to abstract – $ for full-text)

 

RCT: Baricitinib reduced mortality in hospitalized adults with COVID-19.

2 Sep, 2021 | 10:17h | UTC

Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial – The Lancet Respiratory Medicine

Commentaries:

Baricitinib: the first immunomodulatory treatment to reduce COVID-19 mortality in a placebo-controlled trial – The Lancet Respiratory Medicine

Rheumatoid Arthritis Drug Combined with Standard of Care May Help Reduce Mortality for Hospitalized COVID-19 Patients – Vanderbilt University Medical Center

 

Commentaries on Twitter

(thread – click for more)

 

RCT: Among critically ill patients, targeting oxygenation to a low-normal range vs. high-normal range did not result in a reduction in organ dysfunction.

2 Sep, 2021 | 08:23h | UTC

Effect of Low-Normal vs High-Normal Oxygenation Targets on Organ Dysfunction in Critically Ill Patients: A Randomized Clinical Trial – JAMA (free for a limited period)

Related:

M-A of randomized trials: Conservative oxygen therapy for critically ill patients.

Oxygen administration for patients with ARDS – Journal of Intensive Care

Randomized trial: Similar outcomes with lower vs. higher oxygenation targets for acute hypoxemic respiratory failure

Systematic Review: Higher vs. Lower Fraction of Inspired Oxygen or Targets of Arterial Oxygenation for Adults Admitted to the Intensive Care Unit

 

Commentary on Twitter

 

RCT: In patients with acute hypoxemic respiratory failure, a strategy of lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal was not associated with improved outcomes.

2 Sep, 2021 | 08:21h | UTC

Effect of Lower Tidal Volume Ventilation Facilitated by Extracorporeal Carbon Dioxide Removal vs Standard Care Ventilation on 90-Day Mortality in Patients With Acute Hypoxemic Respiratory Failure: The REST Randomized Clinical Trial – JAMA (free for a limited period)

Related: Randomized Trial: Low vs Intermediate Tidal Volume Strategy in ICU Patients Without ARDS

 

Commentary on Twitter

 

RCT: Ketamine administration in patients with acute painful sickle cell crisis was effective for pain control and reduced the cumulative morphine dose in the emergency department.

2 Sep, 2021 | 08:11h | UTC

Ketamine Administration for Acute Painful Sickle Cell Crisis: A Randomized Controlled Trial – Academic Emergency Medicine (link to abstract – $ for full-text)

 

#ESCCongress – RCT: SGLT2 inhibition reduced the combined risk of cardiovascular death or hospitalization in patients with heart failure and a preserved ejection fraction, regardless of the presence or absence of diabetes.

29 Aug, 2021 | 18:19h | UTC

Empagliflozin in Heart Failure with a Preserved Ejection Fraction – New England Journal of Medicine

News release: Trial reports first successful results for heart failure with preserved ejection fraction – European Society of Cardiology

Commentary: Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction – EMPEROR-Preserved – American College of Cardiology

 

Commentary on Twitter

 

#ESCCongress – RCT: In patients with A. Fibrillation who underwent TAVR, Edoxaban was noninferior to Vit. K Antagonist regarding the composite primary outcome of adverse clinical events, but resulted in a higher incidence of major bleeding.

29 Aug, 2021 | 18:17h | UTC

Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR – New England Journal of Medicine

Commentaries:

ENVISAGE-TAVI AF: Edoxaban Disappoints in TAVI Setting – TCTMD

ENVISAGE-TAVI AF: Edoxaban vs. Warfarin Following Heart Valve Replacement – American College of Cardiology

Edoxaban vs. Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation–Atrial Fibrillation – ENVISAGE-TAVI AF – American College of Cardiology

 

#ESCCongress – RCT: In patients who underwent PCI at high bleeding risk, 1 month of dual antiplatelet therapy was noninferior to the continuation of dual therapy for at least 2 additional months and resulted in a lower incidence of bleeding events.

29 Aug, 2021 | 18:16h | UTC

Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk – New England Journal of Medicine

Commentaries:

Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs. Standard DAPT Regimen – MASTER DAPT – American College of Cardiology

MASTER-DAPT: Abbreviated DAPT vs. Standard DAPT in High-Risk Patients Post-PCI – American College of Cardiology

 

#ESCCongress – RCT: Immediate coronary angiography after out-of-hospital cardiac arrest without ST-segment elevation did not improve outcomes compared to delayed/selective angiography.

29 Aug, 2021 | 18:12h | UTC

Angiography after Out-of-Hospital Cardiac Arrest without ST-Segment Elevation – New England Journal of Medicine

News release: Trial does not support early coronary angiography in cardiac arrest without ST elevation – European Society of Cardiology

Commentaries:

Angiography After Out-of-Hospital Cardiac Arrest Without ST-Segment Elevation – TOMAHAWK – American College of Cardiology

TOMAHAWK: Immediate Coronary Angiography vs. Delayed Angiography in OHCA Patients Without ST-Segment Elevation – American College of Cardiology

 

Commentary on Twitter

 

#ESCCongress – RCT: Finerenone reduced CV events in patients with kidney disease and type 2 diabetes (12.4% vs. 14.2% during a median follow-up of 3.4 years), but the risk of hyperkalemia was increased (10.8% vs. 5.3%).

29 Aug, 2021 | 18:14h | UTC

Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes – New England Journal of Medicine

News release: Finerenone benefits patients with diabetes across spectrum of kidney disease – European Society of Cardiology

Commentaries:

Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease – FIGARO-DKD – American College of Cardiology

FIGARO-DKD and FIDELITY Findings Show Benefits of Finerenone to Improve Outcomes in Patients With Kidney Disease, Diabetes – American College of Cardiology

Related:

[Abstract Only] Randomized trial: Effect of Finerenone on chronic kidney disease outcomes in Type 2 diabetes

 

Commentary on Twitter

 

#ESCCongress – RCT: Initial hypertension treatment with a single pill with 4 drugs at quarter doses (irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) achieved better BP lowering vs. standard monotherapy (irbesartan 150 mg).

29 Aug, 2021 | 18:11h | UTC

Initial treatment with a single pill containing quadruple combination of quarter doses of blood pressure medicines versus standard dose monotherapy in patients with hypertension (QUARTET): a phase 3, randomised, double-blind, active-controlled trial – The Lancet (link to abstract – $ for full-text)

Commentary: Quadruple UltrA-low-dose tReaTment for hypErTension – QUARTET – American College of Cardiology

 

#ESCCongress – RCT: Among asymptomatic patients with severe carotid stenosis, carotid surgery and stenting carry similar risks, and the long-term risk of stroke was comparable. There was no medically treated arm in this study.

29 Aug, 2021 | 18:06h | UTC

Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy – The Lancet

 

Commentary on Twitter

 

#ESCCongress – RCT: Small benefit from systematic screening for atrial fibrillation in older adults – After a median follow-up of 6.9 y there were fewer events (stroke, embolism, bleeding, and death) in the intervention group (31·9%) vs. control group (33·0%).

29 Aug, 2021 | 18:08h | UTC

Clinical outcomes in systematic screening for atrial fibrillation (STROKESTOP): a multicentre, parallel group, unmasked, randomised controlled trial – The Lancet (link to abstract – $ for full-text)

News release: Screening for atrial fibrillation could reduce risk of stroke – Karolinska Institutet

 

RCT: Catheter-based adrenal ablation remits primary aldosteronism.

25 Aug, 2021 | 08:52h | UTC

Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial – Circulation (free for a limited period)

 

Commentary on Twitter

 

RCT: Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse.

13 Aug, 2021 | 08:52h | UTC

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial – American Journal of Obstetrics & Gynecology (link to abstract – $ for full-text)

 

Commentary on Twitter (video summary)

 

RCT: third dose of Moderna mRNA vaccine increases immunity in transplant recipients.

12 Aug, 2021 | 09:56h | UTC

Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients – New England Journal of Medicine

Editorial: Third Time’s a Charm — Covid-19 Vaccine Hope for Solid-Organ Transplant Recipients

Related:

Study: Among kidney transplant recipients who did not respond after 2 doses, a third dose of an mRNA-1273 vaccine induced a serologic response in 49% of patients.

Case series: Safety and immunogenicity of a third dose of SARS-CoV-2 vaccine in solid organ transplant recipients.

[Preprint] 3rd AstraZeneca shot gives strong immunity.

 

Commentaries on Twitter

https://twitter.com/hildabast/status/1425576801850433537

 

WHO’s Solidarity clinical trial enters a new phase with three new candidate drugs.

12 Aug, 2021 | 09:02h | UTC

WHO’s Solidarity clinical trial enters a new phase with three new candidate drugs – World Health Organization

Commentary:

WHO-led Trial Will Test Malaria and Cancer Medicines Against COVID-19 – Health Policy Watch

Related:

A giant trial of COVID-19 treatments organized by the WHO is restarting. Here are the drugs it’s betting on.

WHO Solidarity trial to restart with focus on drugs that act on immune responses caused by Covid-19.

 

Commentary on Twitter (thread – click for more)

 

PRINCIPLE RCT: Inhaled budesonide improves time to recovery from COVID-19 in people at high risk of complications in the community.

11 Aug, 2021 | 08:52h | UTC

Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial – The Lancet

Invited Commentary: The use of inhaled corticosteroids in early-stage COVID-19

 

BaSICS RCT: Among critically ill patients requiring fluid therapy, there was no difference in mortality with slower (333 mL/h) vs. faster (999 mL/h) intravenous fluid bolus rates.

11 Aug, 2021 | 08:37h | UTC

Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Does Crystalloid Composition or Rate of Fluid Administration Make a Difference When Resuscitating Patients in the ICU? – JAMA (free for a limited period)

Video: Balanced Solution vs. Saline in Intensive Care Study

 

BaSICS RCT: Among critically ill patients requiring fluid therapy, treatment with a balanced solution did not lead to reduced mortality compared to a 0.9% saline solution.

11 Aug, 2021 | 08:39h | UTC

Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill PatientsThe BaSICS Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Does Crystalloid Composition or Rate of Fluid Administration Make a Difference When Resuscitating Patients in the ICU? – JAMA (free for a limited period)

Video: Balanced Solution vs. Saline in Intensive Care Study

 

Commentary on Twitter

 

RCT: Triaging acute pulmonary embolism for home treatment by Hestia vs. simplified PESI criteria – the tools were similarly effective, and more than a third of patients were treated at home with a low incidence of complications.

11 Aug, 2021 | 08:27h | UTC

Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial – European Heart Journal

 

Commentary on Twitter

 

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