Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients (REDUSE)

March 26, 2026 updated by: Region Skane
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1850

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Finland
      • Helsinki, Finland
        • Recruiting
        • Helsinki University Hospital
      • Kuopio, Finland
        • Not yet recruiting
        • Kuopio University Hospital
      • Tampere, Finland
        • Not yet recruiting
        • Tampere University Hospital
      • Turku, Finland
        • Not yet recruiting
        • Turku University Hospital
  • Sweden
      • Danderyd, Sweden
        • Recruiting
        • Danderyd Hospital
      • Eskilstuna, Sweden
        • Recruiting
        • Malar Hospital
      • Falun, Sweden
        • Recruiting
        • Falun Hospital
      • Gothenburg, Sweden
        • Recruiting
        • Sahlgrenska University Hospital
      • Gothenburg, Sweden
        • Recruiting
        • Östra Hospital
      • Halmstad, Sweden
        • Recruiting
        • Halmstad Hospital
      • Helsingborg, Sweden
        • Recruiting
        • Helsingborg Hospital
      • Lund, Sweden
        • Recruiting
        • Skåne University Hospital, Lund
      • Malmo, Sweden
        • Recruiting
        • Skåne University Hospital, Malmö
      • Norrtälje, Sweden
        • Recruiting
        • Norrtälje Hospital
      • Stockholm, Sweden
        • Recruiting
        • Stockholm South General Hospital (SÖS)
      • Södertälje, Sweden
        • Not yet recruiting
        • Södertälje Hospital
      • Umeå, Sweden
        • Recruiting
        • University Hospital of Umeå
      • Uppsala, Sweden
        • Recruiting
        • Uppsala University Hospital
      • Varberg, Sweden
        • Recruiting
        • Varberg Hospital
      • Örebro, Sweden
        • Recruiting
        • Örebro university hospital
      • Östersund, Sweden
        • Recruiting
        • Östersund Hospital
  • United Kingdom
      • Cardiff, United Kingdom
        • Not yet recruiting
        • University Hospital of Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • Confirmed or suspected pregnancy
  • Previous inclusion in the trial
  • Screened more than 12 hours after ICU admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days after inclusion
All-cause mortality
90 days after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications in the ICU
Time Frame: 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.
From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Cognitive function
Time Frame: 6 months after inclusion
Cognitive function measured using the Montreal Cognitive Assessment (MoCA)
6 months after inclusion
Health-Related Quality of Life
Time Frame: 6 months after inclusion
Health-Related Quality of Life measured using the European Quality of Life visual analogue scale (EQ-VAS)
6 months after inclusion
Mechanical ventilation-free days
Time Frame: Within 90 days after inclusion
Mechanical ventilation-free days
Within 90 days after inclusion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major adverse kidney events (MAKE)
Time Frame: 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)
90 days after inclusion
Cumulative dose of diuretics
Time Frame: 5 days after inclusion
Cumulative dose of diuretics (defined daily doses according to the World Health Organization [WHO])
5 days after inclusion
Glasgow Outcome Scale Extended (GOSE) score
Time Frame: 6 months after inclusion
GOSE score
6 months after inclusion
Health-Related Quality of Life
Time Frame: 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
6 months after inclusion
Health and disability
Time Frame: 6 months after inclusion
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)
Time Frame: 6 months after inclusion
MFIS questionnaire (full-length version)
6 months after inclusion
Mortality
Time Frame: 12 months after inclusion
All-cause mortality
12 months after inclusion
Hypernatremia
Time Frame: 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)
From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Acid-base disturbances
Time Frame: 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])
From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Central venous catheter-related complications
Time Frame: 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)
From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Number of days in the ICU
Time Frame: Within 90 days of inclusion
Number of days in the ICU
Within 90 days of inclusion
Hospital-free days
Time Frame: Within 90 days after inclusion
Hospital-free days
Within 90 days after inclusion
Vasopressor-free days
Time Frame: Within 90 days after inclusion
Vasopressor-free days
Within 90 days after inclusion
Renal replacement therapy (RRT)-free days
Time Frame: Within 90 days after inclusion
RRT-free days
Within 90 days after inclusion
Hypoglycaemia
Time Frame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Bentzer, Region Skane

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REDUSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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