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NCT Number: NCT06140147

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

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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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

Primary outcomes

  1. Mortality

    Time frame: 90 days after inclusion

    All-cause mortality

Secondary outcomes

  1. 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.

  2. Mechanical ventilation-free days

    Time frame: Within 90 days after inclusion

    Mechanical ventilation-free days

  3. Cognitive function

    Time frame: 6 months after inclusion

    Cognitive function measured using the Montreal Cognitive Assessment (MoCA)

  4. 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)

Other outcomes

  1. Hospital-free days

    Time frame: Within 90 days after inclusion

    Hospital-free days

  2. Vasopressor-free days

    Time frame: Within 90 days after inclusion

    Vasopressor-free days

  3. Renal replacement therapy (RRT)-free days

    Time frame: Within 90 days after inclusion

    RRT-free days

  4. 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)

  5. Cumulative dose of diuretics

    Time frame: 5 days after inclusion

    Cumulative dose of diuretics (defined daily doses according to the World Health Organization [WHO])

  6. Glasgow Outcome Scale Extended (GOSE) score

    Time frame: 6 months after inclusion

    GOSE score

  7. 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

  8. 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)

  9. Modified Fatigue Impact Scale (MFIS)

    Time frame: 6 months after inclusion

    MFIS questionnaire (full-length version)

  10. Mortality

    Time frame: 12 months after inclusion

    All-cause mortality

  11. Number of days in the ICU

    Time frame: Within 90 days of inclusion

    Number of days in the ICU

  12. 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)

  13. 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)

  14. 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])

  15. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jane Fisher

CONTACT

[email protected]

Peter Bentzer

CONTACT

[email protected]

+46 42-4061111

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Acronym: REDUSE

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Nov 18, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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