Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
REDUSE
1 other identifier
interventional
1,850
3 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
November 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
April 1, 2026
March 1, 2026
4.1 years
November 14, 2023
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
All-cause mortality
90 days after inclusion
Secondary Outcomes (4)
Complications in the ICU
From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Mechanical ventilation-free days
Within 90 days after inclusion
Cognitive function
6 months after inclusion
Health-Related Quality of Life
6 months after inclusion
Other Outcomes (15)
Hospital-free days
Within 90 days after inclusion
Vasopressor-free days
Within 90 days after inclusion
Renal replacement therapy (RRT)-free days
Within 90 days after inclusion
- +12 more other outcomes
Study Arms (2)
Protocolised reduction of non-resuscitation fluids
EXPERIMENTALParticipants 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
OTHERParticipants receive non-resuscitation fluids according to local routines.
Interventions
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)
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
You may qualify if:
- 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.
You may not qualify if:
- Confirmed or suspected pregnancy
- Screened more than 12 hours after ICU admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (22)
Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, 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
Related Publications (1)
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.
PMID: 40671283DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Bentzer
Region Skåne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2023
First Posted
November 18, 2023
Study Start
November 27, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.