Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study

Objectives: To develop a smartphone application providing sound therapy and cognitive behavioral therapy (CBT) for treating tinnitus and performing a proof-of-concept pilot study evaluating its potential efficacy. Methods: An interactive smartphone application available on iOS and Android platforms was developed, which provided an 8-week tinnitus-specific CBT and personalized and frequency-matched sound therapy. Included patients presented to our tertiary clinic between 2017 and 2018, while those waitlisted were regarded as controls. Three surveys were administrated: Tinnitus Handicap Inventory (THI), Generalized Anxiety Disorder 7-item (GAD-7), and Perceived Stress Scale (PSS). Results: A total of 30 patients enrolled in this study consisting of 20 treatment and 10 control patients and mean age was 55.4 ± 11.6 years. Treatment and control patients had similar age, sex, and pre-enrolment GAD and PSS (all P > .05). Baseline THI scores were also similar between treatment and control cohorts (50.1 ± 21.9 vs 62.0 ± 20.7; P = .15). After 8 weeks, though changes in GAD and PSS scores were similar ( P > .05), the treatment group reported a significantly greater improvement in THI scores (17.7 ± 15.8 vs 5.3 ± 10.5, P = .04). Conclusions: This pilot study demonstrated potentially promising efficacy of a smartphone-based CBT and sound therapy platform for treating tinnitus and encourages future randomized controlled trials on this treatment modality.

Download Full-text

Resuscitation in Paediatric Sepsis Using Metabolic Resuscitation–A Pilot Randomized Controlled Pilot Study in the Paediatric Intensive Care Unit (RESPOND PICU): Study Protocol and Analysis Plan

Frontiers in Pediatrics ◽

10.3389/fped.2021.663435 ◽

2021 ◽

Vol 9 ◽

Author(s):

Luregn J. Schlapbach ◽

Kristen Gibbons ◽

Roberta Ridolfi ◽

Amanda Harley ◽

Michele Cree ◽

...

Keyword(s):

Septic Shock ◽

Ascorbic Acid ◽

Intensive Care ◽

New Zealand ◽

Pilot Study ◽

Organ Dysfunction ◽

Study Protocol ◽

Paediatric Intensive Care ◽

Primary Study ◽

Randomized Controlled

Introduction: Septic shock remains amongst the leading causes of childhood mortality. Therapeutic options to support children with septic shock refractory to initial resuscitation with fluids and inotropes are limited. Recently, the combination of intravenous hydrocortisone with high dose ascorbic acid and thiamine (HAT therapy), postulated to reduce sepsis-related organ dysfunction, has been proposed as a safe approach with potential for mortality benefit, but randomized trials in paediatric patients are lacking. We hypothesize that protocolised early use of HAT therapy (“metabolic resuscitation”) in children with septic shock is feasible and will lead to earlier resolution of organ dysfunction. Here, we describe the protocol of the Resuscitation in Paediatric Sepsis Using Metabolic Resuscitation–A Randomized Controlled Pilot Study in the Paediatric Intensive Care Unit (RESPOND PICU).Methods and Analysis: The RESPOND PICU study is an open label randomized-controlled, two-sided multicentre pilot study conducted in paediatric intensive care units (PICUs) in Australia and New Zealand. Sixty children aged between 28 days and 18 years treated with inotropes for presumed septic shock will be randomized in a 1:1 ratio to either metabolic resuscitation (1 mg/kg hydrocortisone q6h, 30 mg/kg ascorbic acid q6h, 4 mg/kg thiamine q12h) or standard septic shock management. Main outcomes include feasibility of the study protocol and survival free of organ dysfunction censored at 28 days. The study cohort will be followed up at 28-days and 6-months post enrolment to assess neurodevelopment, quality of life and functional status. Biobanking will allow ancillary studies on sepsis biomarkers.Ethics and Dissemination: The study received ethical clearance from Children's Health Queensland Human Research Ethics Committee (HREC/18/QCHQ/49168) and commenced enrolment on June 12th, 2019. The primary study findings will be submitted for publication in a peer-reviewed journal.Trial Registration: Australian and New Zealand Clinical Trials Registry (ACTRN12619000829112). Protocol Version: V1.8 22/7/20.

Download Full-text