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Critically Ill clinical trials

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NCT ID: NCT03333278 Completed - Sepsis Clinical Trials

The Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock Trial

VITAMINS
Start date: May 2, 2018
Phase: Phase 2
Study type: Interventional

Sepsis has been characterised as a dysregulated host response to infection. Adjunctive therapies targeting the inflammatory cascade are being increasingly explored, although to date, have failed to demonstrate consistent benefit, and sepsis continues to manifest poor outcomes. Hospital mortality in patients with septic shock remains as high as 22% in Australia and New Zealand. From a global perspective, 31 million sepsis and 19 million severe sepsis cases are expected to be treated in hospitals all over the world per year. To date, experimental data have reported that both high dose intravenous vitamin C and corticosteroids attenuate the acceleration of the inflammatory cascade and possibly reduce the endothelial injury characteristic of sepsis, enhance the release of endogenous catecholamines and improve vasopressor responsiveness. Therefore, the investigators plan to conduct a feasibility pilot prospective, multi-centre, randomised, open-label, trial in ICU patients with septic shock to test whether the intravenous administration of high dose Vitamin C (6g/d), Thiamine (400mg/d) and Hydrocortisone (200mg/d) leads to a more rapid resolution shock and vasopressor dependence.

NCT ID: NCT03292237 Completed - Critical Illness Clinical Trials

Intensive Nutrition in Critically Ill Adults

INTENT
Start date: October 15, 2018
Phase: Phase 2
Study type: Interventional

Despite the widespread use of nutrition therapy, no large scale randomized controlled trials (RCTs) have demonstrated positive outcomes with delivery of nutrition therapy early in critical illness, with some showing no effect with delayed nutrition or even harm. There are several possible reasons for the lack of observed benefit from RCTs to date; interventions have been short in duration (usually 3-10 days after intensive care unit (ICU) admission), perhaps applied at the incorrect time in regards to the patients metabolism and recovery, do not consider the patients nutrition risk, and have not addressed what happens to nutrition intake post ICU in critically ill individuals. This may explain why RCTs to date have not observed any positive associations with the delivery of nutrition; our focus to date may have been on the wrong stage of illness. A future study is thus urgently needed, which addresses the deficiencies in current RCTs by optimizing nutrition delivery for the whole hospital stay and collecting meaningful clinical, process and outcome data, which will potentially inform a larger trial of a similar nature. This initial study aims to determine whether optimization of energy using a pre-tested supplemental parenteral nutrition (PN) strategy in the Intensive Care Unit (ICU) and an intensive nutrition intervention in the post ICU period will deliver more total energy than standard nutrition care during hospital admission in a group of critically ill patients with at least one organ system failure.

NCT ID: NCT03276650 Completed - Critically Ill Clinical Trials

Admission of Adult-onset Still Disease Patients in the ICU

Still-ICU
Start date: September 1, 2017
Phase:
Study type: Observational

Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains challenging. Rarely, AOSD may present severe systemic manifestations and require intensive care. The main purpose of the Stil ICU study is to make the first description of the epidemiology of critically ill AOSD patients. The investigators will use a retrospective cohort study design with dual recruitment strategies: (1) via the AOSD referral centres network and (2) via a French academic medical ICU network.

NCT ID: NCT03249051 Completed - Critically Ill Clinical Trials

Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients.

ONCA
Start date: January 11, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether an individualized determination of energy requirements using indirect calorimetry instead of a formula-based approach leads to an optimized nutritional support and as a consequence to an optimized nutritional status of the critically ill, mechanically ventilated patients measured by the phase angle.

NCT ID: NCT03214575 Completed - Critically Ill Clinical Trials

Ultrasound Guided Central Venous Vascular Access - Novel Needle Navigation Technology Compared With Conventional Method

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

Background: Central venous catheter (CVC) insertion is a very common procedure in the intensive care setting. A recent international guidelines advocated the use of ultrasound for routine internal jugular CVC insertion. The needle navigation technology is a new innovation, also known as guided positioning system (GPS) which allows clinician to visualize the needle position and trajectory in real time as it approaches the target. We hypothesised that the use of GPS would increase success rate and decrease performance time in vascular access procedures. Objectives: To compare the success, efficacy and safety of the procedure using the ultrasound guidance (UG) with conventional versus GPS method. Methods: This was a prospective randomized controlled study in a single centre - intensive care unit. 100 patients were randomized into two groups (50 each each). Subjects would receive CVC insertion via internal jugular vein using ultrasound guidance out of plane approach by conventional versus GPS method. Outcomes measured were the procedure efficacy, safety, level of operators' experience and their satisfaction.

NCT ID: NCT03060668 Completed - Critically Ill Clinical Trials

Optimized Caloric-proteic Nutrition in Critically Ill Patients

Start date: June 2016
Phase: N/A
Study type: Interventional

In this prospective randomized controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and a high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day and protein intake usually recommended to critically ill patients (1.4 to 1.5 grams/kg/day).

NCT ID: NCT03005145 Completed - Sepsis Clinical Trials

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness

BALANCE
Start date: February 24, 2017
Phase: N/A
Study type: Interventional

The World Health Organization, U.S. Centers for Disease Control and Prevention, Association of Medical Microbiology and Infectious Diseases (AMMI) Canada, and Health Canada have all declared antimicrobial resistance a global threat to health, based on rapidly increasing resistance rates and declining new drug development. Up to 30-50% of antibiotic use is inappropriate, and excessive durations of treatment are the greatest contributor to inappropriate use. Shorter duration treatment (≤7 days) has been shown in meta-analyses to be as effective as longer antibiotic treatment for a range of mild to moderate infections. A landmark trial in critically ill patients with ventilator-associated pneumonia showed that mortality and relapse rates were non-inferior in patients who received 8 vs 15 days of treatment. Similar adequately powered randomized trial evidence is lacking for the treatment of patients with bloodstream infections caused by a wide spectrum of organisms.

NCT ID: NCT02976155 Completed - Critically Ill Clinical Trials

The Effect of Standardized Enteral Nutrition on Critically Ill Patients

Start date: October 2016
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.

NCT ID: NCT02962102 Completed - Acute Kidney Injury Clinical Trials

Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury

ACTIVATE-AKI
Start date: April 3, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney injury (AKI) in critically ill patients.

NCT ID: NCT02860572 Completed - Sepsis Clinical Trials

Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Critically Ill

RESPONSE
Start date: January 10, 2017
Phase: N/A
Study type: Interventional

Background: After hypotension, oliguria (urine output less than 0.5 mL/kg/h) was the most common trigger to administer fluid bolus in a multinational practice survey in intensive care. The effect of fluid bolus on cardiovascular variables can be very short-lived among patients in shock suggesting that fluid boluses in the optimization phase are unlikely to improve patient-centered outcomes. Moreover, a growing body of evidence suggests a poor renal response to fluid bolus. Objective: To investigate, whether fluid bolus - as a standard of care - improves urine output in oliguric patients compared to a non-interventional follow-up approach without fluid bolus. Design: Investigator-initiated, open, randomized, controlled study Interventions: 1. Intervention group - follow-up without intervention 2. Control group - fluid bolus (500mL of balanced crystalloid over 30 minutes) Randomization: 1:1 stratified according to the site, presence of acute kidney injury, and sepsis Trial size: 130 patients randomized in 2 ICUs