NCT05249088

Brief Summary

The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2023

Completed
Last Updated

December 11, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

February 8, 2022

Last Update Submit

December 4, 2023

Conditions

Shock, Septic

Outcome Measures

Primary Outcomes (1)

  • Difference in fluid administration

    Total difference in litres of administered fluids between groups

    Within the first three days after inclusion (days 0-3)

Secondary Outcomes (4)

  • Proportion of participants with sufficient clinical outcome data

    Within 90 days after inclusion

  • Proportion of participants assessed by EQ5D-5L and MoCA

    6 months after inclusion

  • Inclusion of eligible patients

    During inclusion

  • Protocol violations

    Within 90 days after inclusion

Other Outcomes (14)

  • Mortality

    90 days after inclusion

  • Complications in the ICU

    from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days

  • Days alive and free of mechanical ventilation

    Within 90 days after inclusion

  • +11 more other outcomes

Study Arms (2)

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.

Other: Protocolised reduction of non-resuscitation fluids

Usual Care

OTHER

Participants receive non-resuscitation fluids according to local routines.

Other: Usual care

Interventions

Protocolised reduction of non-resuscitation fluidsOTHER

* Maintenance fluids are discontinued in participants with positive cumulative fluid balance who are not dehydrated * Intravenous fluid and enteral water are given as needed to correct electrolyte disturbances * Enteral nutrition with energy density of at least 2 kcal/ml is administered according to local practice * Starting 72 hours after inclusion, glucose at a concentration of at least 20% and a maximal dose of 1g/kg/day may be used as nutrition if enteral feeding is not tolerated. Glucose at this dose or lower may be started earlier in patients with insulin dependent diabetes if enteral feeding is not tolerated and local protocol mandates this * Parenteral nutrition is administered according to local protocol * Intravenous medications are concentrated according to a predefined protocol * Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids such that total dose of fluids covers the daily need of water (about 1ml/kg/h)

Protocolised reduction of non-resuscitation fluids
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) are given at a dose of 1 ml/kg/h unless local protocol states otherwise * Glucose is used at maximal concentration of 10% unless local protocol states otherwise. * Medications are concentrated according to local protocol

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (≥ 18 years of age)
  • Septic shock according to the Sepsis 3 criteria: suspected or confirmed infection AND infusion of vasopressor/inotrope to maintain mean arterial pressure of 65 mmHg or above despite adequate fluid resuscitation AND lactate of 2 mmol/L or above at any time following ICU admission when there was a simultaneous need for vasopressor/inotrope.

You may not qualify if:

  • Confirmed or suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Halmstad Hospital

Halmstad, Sweden

Location

Helsingborg Hospital

Helsingborg, Sweden

Location

Kristianstad Hospital

Kristianstad, Sweden

Location

Skåne University Hospital, Lund

Lund, Sweden

Location

Skåne University Hospital, Malmö

Malmo, Sweden

Location

Östersund Hospital

Östersund, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (2)

  • Linden A, Fisher J, Lilja G, Olsen MH, Sjovall F, Jungner M, Spangfors M, Samuelsson L, Oras J, Linder A, Unden J, Kander T, Lipcsey M, Nielsen N, Jakobsen JC, Bentzer P. Protocolised reduction of non-resuscitation fluids versus usual care in patients with septic shock (REDUSE): a protocol for a multicentre feasibility trial. BMJ Open. 2023 Feb 28;13(2):e065392. doi: 10.1136/bmjopen-2022-065392.

    PMID: 36854601BACKGROUND

  • Linden A, Spangfors M, Olsen MH, Fisher J, Lilja G, Sjovall F, Jungner M, Lengquist M, Kander T, Samuelsson L, Johansson J, Palmnas E, Unden J, Oras J, Cronhjort M, Chew M, Linder A, Lipcsey M, Nielsen N, Jakobsen JC, Bentzer P; REDUSE Trial Group. Protocolized reduction of non-resuscitation fluids versus usual care in septic shock patients (REDUSE): a randomized multicentre feasibility trial. Crit Care. 2024 May 17;28(1):166. doi: 10.1186/s13054-024-04952-w.

    PMID: 38760833DERIVED

Related Links

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Peter Bentzer, MD, PhD

    Region Skåne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The clinical team caring for participants will not be blinded due to nature of the intervention. The participants, their family and health personnel responsible for outcome assessment at follow-up will be blinded to the allocation of the intervention. The steering group, author group, trial statistician, outcome assessors, prognosticators, statisticians, and the trial coordinating team will be blinded to group allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 21, 2022

Study Start

March 1, 2022

Primary Completion

September 13, 2022

Study Completion

March 27, 2023

Last Updated

December 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Beginning 9 months 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.

Locations

SE(8)