Septic Shock Clinical Trial
— REDUSEOfficial title:
Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
NCT number | NCT06140147 |
Other study ID # | REDUSE |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 27, 2023 |
Est. completion date | July 1, 2028 |
The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.
Status | Recruiting |
Enrollment | 1850 |
Est. completion date | July 1, 2028 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult (= 18 years of age) - Septic shock according to the Sepsis 3 criteria at any time within 12 hours after ICU admission (suspected or confirmed infection, plasma lactate above 2 mmol/L, and infusion of vasopressor/inotrope to maintain mean arterial pressure of 65mmHg or above after receiving adequate fluid resuscitation [> 1L within 12 h of screening]) and need for vasopressors at the time of screening. Exclusion Criteria: - Confirmed or suspected pregnancy - Previous inclusion in the trial - Screened more than 12 hours after ICU admission |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Gothenburg | |
Sweden | Halmstad Hospital | Halmstad | |
Sweden | Helsingborg Hospital | Helsingborg | |
Sweden | Skåne University Hospital, Lund | Lund | |
Sweden | Skåne University Hospital, Malmö | Malmö | |
Sweden | Östersund Hospital | Östersund | |
Sweden | Södersjukhuset | Stockholm | |
Sweden | University Hospital of Umeå | Umeå | |
Sweden | Uppsala University Hospital | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hospital-free days | Hospital-free days | Within 90 days after inclusion | |
Other | Vasopressor-free days | Vasopressor-free days | Within 90 days after inclusion | |
Other | Renal replacement therapy (RRT)-free days | RRT-free days | Within 90 days after inclusion | |
Other | Major adverse kidney events (MAKE) | The composite of death, new receipt of renal replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value =200% of the baseline value) | 90 days after inclusion | |
Other | Cumulative dose of diuretics | Cumulative dose of diuretics (defined daily doses according to the World Health Organization [WHO]) | 5 days after inclusion | |
Other | Glasgow Outcome Scale Extended (GOSE) score | GOSE score | 6 months after inclusion | |
Other | Health-Related Quality of Life | Health-Related Quality of Life measured using the European Quality of Life visual 5-dimension 5-level scale (EQ-5D-5L) questionnaire | 6 months after inclusion | |
Other | Health and disability | Health and disability measured using the WHO Disability Assessment Schedule (WHODAS) 2.0 (12 item version) | 6 months after inclusion | |
Other | Modified Fatigue Impact Scale (MFIS) | MFIS questionnaire (full-length version) | 6 months after inclusion | |
Other | Mortality | All-cause mortality | 12 months after inclusion | |
Other | Number of days in the ICU | Number of days in the ICU | Within 90 days of inclusion | |
Other | Hypoglycaemia | Number of patients with moderate hypoglycaemia (glucose 3.9 - 2.3 mmol/l) and severe hypoglycaemia (glucose = 2.2 mmol/l) | From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days | |
Other | Hypernatremia | Number of patients with hypernatremia (sodium > 159 mmol/L) | From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days | |
Other | Acid-base disturbances | Number of patients with acid-base disturbances (hyperchloremic acidosis [pH < 7.15 and plasma Cl- > 115] or metabolic alkalosis [pH > 7.59 and S-BE > 9]) | From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days | |
Other | Central venous catheter-related complications | Number of patients with any central venous catheter related complications that could potentially be related to concentrated drugs given in the intervention group (for example, thrombosis, stenosis, malfunction, and infections) | From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days | |
Primary | Mortality | All-cause mortality | 90 days after inclusion | |
Secondary | Complications in the ICU | Number of patients with one or more of the following complications in the ICU: cerebral, cardiac, intestinal or limb ischemia, or any acute kidney injury. | From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days | |
Secondary | Mechanical ventilation-free days | Mechanical ventilation-free days | Within 90 days after inclusion | |
Secondary | Cognitive function | Cognitive function measured using the Montreal Cognitive Assessment (MoCA) | 6 months after inclusion | |
Secondary | Health-Related Quality of Life | Health-Related Quality of Life measured using the European Quality of Life visual analogue scale (EQ-VAS) | 6 months after inclusion |
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