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

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• Shock, Septic 1,078

Keywords

• septic shock

Shock, Septic

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 1,850 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.

Lead sponsor

Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.

Study arms

• 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

• Other
  Usual Care

  Participants receive non-resuscitation fluids according to local routines.

  Other: Usual care

Interventions

• OtherProtocolised 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)

• OtherUsual 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

Primary outcomes

1. Mortality

   All-cause mortality

   Time frame: 90 days after inclusion

Secondary outcomes

1. 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.

   Time frame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days

2. Mechanical ventilation-free days

   Mechanical ventilation-free days

   Time frame: Within 90 days after inclusion

3. Cognitive function

   Cognitive function measured using the Montreal Cognitive Assessment (MoCA)

   Time frame: 6 months after inclusion

4. Health-Related Quality of Life

   Health-Related Quality of Life measured using the European Quality of Life visual analogue scale (EQ-VAS)

   Time frame: 6 months after inclusion

Other outcomes

1. Hospital-free days

   Hospital-free days

   Time frame: Within 90 days after inclusion

2. Vasopressor-free days

   Vasopressor-free days

   Time frame: Within 90 days after inclusion

3. Renal replacement therapy (RRT)-free days

   RRT-free days

   Time frame: Within 90 days after inclusion

4. Major adverse kidney events (MAKE)

   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)

   Time frame: 90 days after inclusion

5. Cumulative dose of diuretics

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

   Time frame: 5 days after inclusion

6. Glasgow Outcome Scale Extended (GOSE) score

   GOSE score

   Time frame: 6 months after inclusion

7. Health-Related Quality of Life

   Health-Related Quality of Life measured using the European Quality of Life visual 5-dimension 5-level scale (EQ-5D-5L) questionnaire

   Time frame: 6 months after inclusion

8. Health and disability

   Health and disability measured using the WHO Disability Assessment Schedule (WHODAS) 2.0 (12 item version)

   Time frame: 6 months after inclusion

9. Modified Fatigue Impact Scale (MFIS)

   MFIS questionnaire (full-length version)

   Time frame: 6 months after inclusion

10. Mortality

    All-cause mortality

    Time frame: 12 months after inclusion

11. Number of days in the ICU

    Number of days in the ICU

    Time frame: Within 90 days of inclusion

12. Hypoglycaemia

    Number of patients with moderate hypoglycaemia (glucose 3.9 - 2.3 mmol/l) and severe hypoglycaemia (glucose ≤ 2.2 mmol/l)

    Time frame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days

13. Hypernatremia

    Number of patients with hypernatremia (sodium \> 159 mmol/L)

    Time frame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days

14. Acid-base disturbances

    Number of patients with acid-base disturbances (hyperchloremic acidosis \[pH \< 7.15 and plasma Cl- \> 115\] or metabolic alkalosis \[pH \> 7.59 and S-BE \> 9\])

    Time frame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days

15. Central venous catheter-related complications

    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)

    Time frame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days

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 ↗

Individual participant data

Plan to share: 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.