REDUSE: Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Protocolised reduction of non-resuscitation fluids Participants receive non-resuscitation fluids according to a pre-defined protocol starting within two hours of randomization. The intervention is continued for the duration of the ICU admission up to a maximum of 90 days. |
Other: Protocolised reduction of non-resuscitation fluids
Maintenance fluid: discontinued if cumulative fluid balance is positive and patient is not dehydrated Intravenous fluid and enteral water: as needed to correct electrolyte disturbances Enteral nutrition (at least 2 kcal/ml): per local practice Glucose (conc. ≥20%, dose ≤1g/kg/day): may be used as nutrition if enteral feeding not tolerated starting 72h after inclusion. May be started earlier in patients with insulin-dependent diabetes or risk of hypoglycemia per local practice Parenteral nutrition: per local practice Intravenous medications: concentrated according to a predefined protocol Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids so the total dose of fluids covers the daily need of water (about 1ml/kg/h)
|
| Other: Usual Care Participants receive non-resuscitation fluids according to local routines. |
Other: Usual care
Participants receive non-resuscitation fluids according to local routines, with the following stipulations:
Maintenance fluids (crystalloids and/or glucose and/or enteral water): given at a dose of 1 ml/kg/h unless local protocol states otherwise Glucose: used at maximal concentration of 10% unless local protocol states otherwise.
Medications: concentrated per local protocol
|
Outcome Measures
Primary Outcome Measures
- Mortality [90 days after inclusion]
All-cause mortality
Secondary Outcome Measures
- Complications in the ICU [From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days]
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.
- Days alive and free of mechanical ventilation [Within 90 days after inclusion]
Days alive and free of mechanical ventilation
- Cognitive function [6 months after inclusion]
Cognitive function measured using the Montreal Cognitive Assessment (MoCA)
- Health-Related Quality of Life [6 months after inclusion]
Health-Related Quality of Life measured using the European Quality of Life visual analogue scale (EQ-VAS)
Other Outcome Measures
- Days alive and free of vasopressor therapy [Within 90 days after inclusion]
Days alive and free of vasopressor therapy
- Days alive and free of renal replacement therapy (RRT) [Within 90 days after inclusion]
Days alive and free of RRT
- Major adverse kidney events (MAKE) [90 days after inclusion]
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)
- Cumulative dose of diuretics [5 days after inclusion]
Cumulative dose of diuretics (defined daily doses according to the World Health Organization [WHO])
- Glasgow Outcome Scale Extended (GOSE) score [6 months after inclusion]
GOSE score
- Health-Related Quality of Life [6 months after inclusion]
Health-Related Quality of Life measured using the European Quality of Life visual 5-dimension 5-level scale (EQ-5D-5L) questionnaire
- Health and disability [6 months after inclusion]
Health and disability measured using the WHO Disability Assessment Schedule (WHODAS) 2.0 (12 item version)
- Modified Fatigue Impact Scale (MFIS) [6 months after inclusion]
MFIS questionnaire (full-length version)
- Mortality [12 months after inclusion]
All-cause mortality
- Days alive and out of hospital [Within 90 days after inclusion]
Days alive and out of hospital
- Hypoglycaemia [From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days]
Number of patients with hypoglycaemia (glucose ≤ 3.9 mmol/l)
- Hypernatremia [From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days]
Number of patients with hypernatremia (sodium > 159 mmol/L)
- Acid-base disturbances [From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days]
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])
- Central venous catheter-related complications [From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days]
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)
Eligibility Criteria
Criteria
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:
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Confirmed or suspected pregnancy
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Previous inclusion in the trial
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Screened more than 12 hours after ICU admission
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Halmstad Hospital | Halmstad | Sweden | ||
| 2 | Helsingborg Hospital | Helsingborg | Sweden | ||
| 3 | Skåne University Hospital, Lund | Lund | Sweden | ||
| 4 | Skåne University Hospital, Malmö | Malmö | Sweden | ||
| 5 | Uppsala University Hospital | Uppsala | Sweden | ||
| 6 | Östersund Hospital | Östersund | Sweden |
Sponsors and Collaborators
- Region Skane
Investigators
- Principal Investigator: Peter Bentzer, Region Skåne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REDUSE