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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protocolised reduction of non-resuscitation fluids | Experimental | 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. |
|
| Usual Care | Other | Participants receive non-resuscitation fluids according to local routines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocolised reduction of non-resuscitation fluids | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All-cause mortality | 90 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mechanical ventilation-free days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital-free days | Hospital-free days | Within 90 days after inclusion |
| Vasopressor-free days | Vasopressor-free days | Within 90 days after inclusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Bentzer | Contact | +46 42-4061111 | Peter.Bentzer@med.lu.se | |
| Jane Fisher | Contact | jane.fisher@advansci-research.com |
| Name | Affiliation | Role |
|---|---|---|
| Peter Bentzer | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Recruiting | Helsinki | Finland | |||
| Kuopio University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40671283 | Derived | Bentzer P, Linden A, Olsen MH, Lilja G, Fisher J, Sjovall F, Kander T, Lengquist M, Samuelsson L, Unden J, Palmnas E, Oras J, Cronhjort M, Balintescu A, Lind A, Ahlstrom B, Meirik M, Savilampi J, Pekkarinen P, Berggren A, Oscarsson N, Said M, Castegren M, Faria S, Hemberg L, Linder A, Lipcsey M, Skrifvars MB, Wise MP, Nielsen N, Jakobsen JC. Protocolized REDUction of Non-Resuscitation Fluids in SEptic Shock Patients. A Protocol for the REDUSE Randomized Clinical Trial. Acta Anaesthesiol Scand. 2025 Aug;69(7):e70095. doi: 10.1111/aas.70095. |
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Approximately one year after publication of the main report of this trial individual de-identified data will be available for sharing with researchers who provide a methodologically sound proposal as judged by the steering committee. To gain access, data requestors will need to sign a data access agreement.
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The clinical team caring for participants will not be blinded due to the nature of the intervention. The participants and their family will not be actively informed about group allocation. The steering group, author group, trial statistician, outcome assessors, prognosticators, the trial coordinating team, manuscript writers and the data safety and monitoring committee will be blinded to group allocation.
|
| Usual care | Other | 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 |
|
Mechanical ventilation-free days |
| Within 90 days after inclusion |
| Cognitive function | Cognitive function measured using the Montreal Cognitive Assessment (MoCA) | 6 months after inclusion |
| 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 |
| Renal replacement therapy (RRT)-free days | RRT-free days | Within 90 days after inclusion |
| 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 |
| Cumulative dose of diuretics | Cumulative dose of diuretics (defined daily doses according to the World Health Organization [WHO]) | 5 days after inclusion |
| Glasgow Outcome Scale Extended (GOSE) score | GOSE score | 6 months after inclusion |
| 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 |
| Health and disability | Health and disability measured using the WHO Disability Assessment Schedule (WHODAS) 2.0 (12 item version) | 6 months after inclusion |
| Modified Fatigue Impact Scale (MFIS) | MFIS questionnaire (full-length version) | 6 months after inclusion |
| Mortality | All-cause mortality | 12 months after inclusion |
| Number of days in the ICU | Number of days in the ICU | Within 90 days of inclusion |
| 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 |
| 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 |
| 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 |
| 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 |
| Not yet recruiting |
| Kuopio |
| Finland |
| Tampere University Hospital | Not yet recruiting | Tampere | Finland |
| Turku University Hospital | Not yet recruiting | Turku | Finland |
| Danderyd Hospital | Recruiting | Danderyd | Sweden |
| Malar Hospital | Recruiting | Eskilstuna | Sweden |
| Falun Hospital | Recruiting | Falun | Sweden |
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Sweden |
| Östra Hospital | Recruiting | Gothenburg | Sweden |
| Halmstad Hospital | Recruiting | Halmstad | Sweden |
| Helsingborg Hospital | Recruiting | Helsingborg | Sweden |
| Skåne University Hospital, Lund | Recruiting | Lund | Sweden |
| Skåne University Hospital, Malmö | Recruiting | Malmö | Sweden |
| Norrtälje Hospital | Recruiting | Norrtälje | Sweden |
| Örebro University Hospital | Recruiting | Örebro | Sweden |
| Östersund Hospital | Recruiting | Östersund | Sweden |
| Södertälje Hospital | Not yet recruiting | Södertälje | Sweden |
| Stockholm South General Hospital (SÖS) | Recruiting | Stockholm | Sweden |
| University Hospital of Umeå | Recruiting | Umeå | Sweden |
| Uppsala University Hospital | Recruiting | Uppsala | Sweden |
| Varberg Hospital | Recruiting | Varberg | Sweden |
| University Hospital of Wales | Not yet recruiting | Cardiff | United Kingdom |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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