Septic ShockREDUSENCT06140147
Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
A study testing Protocolised reduction of non-resuscitation fluids in people with Septic Shock, run by Region Skane at 22 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Protocolised reduction of non-resuscitation fluids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,850 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 27 Nov 2023to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Confirmed or suspected pregnancy
- Previous inclusion in the trial
- Screened more than 12 hours after ICU admission
Trial locations and contacts
22 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Jane Fisher contact
22 sites in 3 countries
Sweden17 sites, 17 recruiting
- Recruiting
Danderyd Hospital
Danderyd
- Recruiting
Malar Hospital
Eskilstuna
- Recruiting
Falun Hospital
Falun
- Recruiting
Sahlgrenska University Hospital
Gothenburg
- Recruiting
Östra Hospital
Gothenburg
- Recruiting
Halmstad Hospital
Halmstad
- Recruiting
Helsingborg Hospital
Helsingborg
- Recruiting
Skåne University Hospital, Lund
Lund
- Recruiting
Skåne University Hospital, Malmö
Malmö
- Recruiting
Norrtälje Hospital
Norrtälje
- Recruiting
Örebro University Hospital
Örebro
- Recruiting
Östersund Hospital
Östersund
- Recruiting
Södertälje Hospital
Södertälje
- Recruiting
Stockholm South General Hospital (SÖS)
Stockholm
- Recruiting
University Hospital of Umeå
Umeå
- Recruiting
Uppsala University Hospital
Uppsala
- Recruiting
Varberg Hospital
Varberg
Finland4 sites, 4 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
- Not yet recruiting
Kuopio University Hospital
Kuopio
- Recruiting
Tampere University Hospital
Tampere
- Not yet recruiting
Turku University Hospital
Turku
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital of Wales
Cardiff
About this study
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.
- Conditions
- Septic Shock
- Being tested
- Protocolised reduction of non-resuscitation fluids, Usual care
- Keywords
- septic shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolised reduction of non-resuscitation fluidsOther
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 careOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Protocolised reduction of non-resuscitation fluids |
| Usual Care | Other | Participants receive non-resuscitation fluids according to local routines. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality
Measured: 90 days after inclusion
Secondary outcomes (4)
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.
Measured: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Mechanical ventilation-free days
Mechanical ventilation-free days
Measured: Within 90 days after inclusion
Cognitive function
Cognitive function measured using the Montreal Cognitive Assessment (MoCA)
Measured: 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)
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start27 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Bentzer, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140147
- Sponsor's protocol ID
- REDUSE
- Acronym
- REDUSE
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40671283
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT06140147
- Acronym / sponsor ID
- REDUSE / REDUSE
- Conditions
- Septic Shock
- Keywords
- septic shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,850 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocolised reduction of non-resuscitation fluids | Experimental | Other: Protocolised reduction of non-resuscitation fluidsParticipants 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 | Other: Usual careParticipants receive non-resuscitation fluids according to local routines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Confirmed or suspected pregnancy
- Previous inclusion in the trial
- Screened more than 12 hours after ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocolised reduction of non-resuscitation fluidsMaintenance 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 | Protocolised reduction of non-resuscitation fluids |
| Usual careParticipants 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 | Other | Usual Care |
Primary outcome
Mortality
Time frame: 90 days after inclusion
All-cause mortality
4 secondary outcomes
Complications in the ICU
Time frame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Mechanical ventilation-free days
Time frame: Within 90 days after inclusion
Cognitive function
Time frame: 6 months after inclusion
Health-Related Quality of Life
Time frame: 6 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Derived from this study: PubMed 40671283Bentzer 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jane Fisher contact
Peter Bentzer principal investigator
Region Skane
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolised reduction of non-resuscitation fluids in people with Septic Shock, run by Region Skane at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Sweden, Finland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Bentzer (+46 42-4061111, Peter.Bentzer@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 90 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06140147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.