Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
NCT ID: NCT06140147
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1850 participants
INTERVENTIONAL
2023-11-27
2028-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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)
Usual Care
Participants receive non-resuscitation fluids according to local routines.
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
Interventions
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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)
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous inclusion in the trial
* Screened more than 12 hours after ICU admission
18 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Peter Bentzer
Role: PRINCIPAL_INVESTIGATOR
Region Skåne
Locations
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Helsinki University Hospital
Helsinki, , Finland
Tampere University Hospital
Tampere, , Finland
Danderyd Hospital
Danderyd, , Sweden
Malar Hospital
Eskilstuna, , Sweden
Falun Hospital
Falun, , Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Östra Hospital
Gothenburg, , Sweden
Halmstad Hospital
Halmstad, , Sweden
Helsingborg Hospital
Helsingborg, , Sweden
Skåne University Hospital, Lund
Lund, , Sweden
Skåne University Hospital, Malmö
Malmo, , Sweden
Norrtälje Hospital
Norrtälje, , Sweden
Örebro University Hospital
Örebro, , Sweden
Östersund Hospital
Östersund, , Sweden
Södertälje Hospital
Södertälje, , Sweden
Stockholm South General Hospital (SÖS)
Stockholm, , Sweden
University Hospital of Umeå
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Varberg Hospital
Varberg, , Sweden
University Hospital of Wales
Cardiff, , United Kingdom
Countries
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Central Contacts
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References
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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.
Other Identifiers
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REDUSE
Identifier Type: -
Identifier Source: org_study_id