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

Overview

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.

Interventions

• 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 nutritio
• 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

Primary outcome measures

• Mortality [Time frame: 90 days after inclusion]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Sweden · 17 centers

• Danderyd Hospital — Danderyd
• Malar Hospital — Eskilstuna
• Falun Hospital — Falun
• Sahlgrenska University Hospital — Gothenburg
• Östra Hospital — Gothenburg
• Halmstad Hospital — Halmstad
• Helsingborg Hospital — Helsingborg
• Skåne University Hospital, Lund — Lund
• … and 9 more centers

Finland · 4 centers

• Helsinki University Hospital — Helsinki
• Kuopio University Hospital — Kuopio
• Tampere University Hospital — Tampere
• Turku University Hospital — Turku

United Kingdom · 1 center

• University Hospital of Wales — Cardiff

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 SE PMID 40671283

Identifiers

NCT: NCT06140147 · REDUSE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗