Septic Shock Clinical Trial
— FRESHLYOfficial title:
Fluid Restricted Resuscitation in Sepsis With Hypotension Meta-Analysis (FRESHLY): Individual Patient Data Met-analysis of the ARISE FLUIDS, CLASSIC, CLOVERS and EVIS Trials
Verified date | October 2023 |
Source | Australian and New Zealand Intensive Care Research Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.
Status | Not yet recruiting |
Enrollment | 7838 |
Est. completion date | November 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Participants of the ARISE FLUIDS, CLASSIC, CLOVERS & EVIS trials who had: - Suspected or proven infection - Systolic blood pressure (SBP) <100 mm Hg OR mean arterial pressure (MAP) <65 mm Hg - Lactate = 2.0 mmol/L - Requirement for vasopressors to meet perfusion targets Exclusion criteria: Participants not in the ARISE FLUIDS, CLASSIC, CLOVERS & EVIS trials |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Australian and New Zealand Intensive Care Research Centre |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality at 90 days post randomisation | Death from any cause at 90 days after randomisation | 90 days | |
Secondary | Time from randomisation to death | Time from randomisation to death | Up to day 90 | |
Secondary | Incidence of mechanical ventilation | Commencement of mechanical ventilation from randomisation until day 90 post-randomisation | from randomisation until day 90 post-randomisation | |
Secondary | Incidence of acute renal replacement therapy | Commencement of renal replacement therapy from randomisation until day 90 post-randomisation | from randomisation until day 90 post-randomisation | |
Secondary | Days alive free of organ support at 28 days post randomisation | days the patient is alive and receiving nil organ support from from randomisation until day 28 post-randomisation | from randomisation until day 28 post-randomisation | |
Secondary | Duration of hospital stay | Length of time in hospital from randomisation until death or hospital discharge or day 90 post-randomisation | From randomisation until day 90 post-randomisation | |
Secondary | Incidence of serious adverse events | Number of adverse events from randomisation until day 90 post-randomisation | from randomisation until day 90 post-randomisation | |
Secondary | Duration of intensive care unit (ICU) stay | Length of time in ICU from randomisation until death or hospital discharge or day 90 post-randomisation | From randomisation until day 90 post-randomisation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03649633 -
Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock
|
Phase 1/Phase 2 | |
Terminated |
NCT04117568 -
The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
|
||
Completed |
NCT04227652 -
Control of Fever in Septic Patients
|
N/A | |
Completed |
NCT05629780 -
Temporal Changes of Lactate in CLASSIC Patients
|
N/A | |
Recruiting |
NCT04796636 -
High-dose Intravenous Vitamin C in Patients With Septic Shock
|
Phase 1 | |
Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
Recruiting |
NCT04005001 -
Machine Learning Sepsis Alert Notification Using Clinical Data
|
Phase 2 | |
Recruiting |
NCT05217836 -
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
|
||
Recruiting |
NCT05066256 -
LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock
|
N/A | |
Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 | |
Not yet recruiting |
NCT04516395 -
Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae
|
N/A | |
Recruiting |
NCT02899143 -
Short-course Antimicrobial Therapy in Sepsis
|
Phase 2 | |
Recruiting |
NCT02565251 -
Volemic Resuscitation in Sepsis and Septic Shock
|
N/A | |
Recruiting |
NCT02676427 -
Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
|
||
Recruiting |
NCT02580240 -
Administration of Hydrocortisone for the Treatment of Septic Shock
|
N/A | |
Not yet recruiting |
NCT02547467 -
TOADS Study: TO Assess Death From Septic Shock.
|
N/A | |
Terminated |
NCT02335723 -
ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber
|
N/A | |
Completed |
NCT02638545 -
Hemodynamic Effects of Dexmedetomidine in Septic Shock
|
Phase 3 | |
Completed |
NCT02306928 -
PK Analysis of Piperacillin in Septic Shock Patients
|
N/A | |
Completed |
NCT02079402 -
Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care
|
Phase 4 |