Protocolized Reduction of Non-resuscitation Fluids vs Usual Care in Septic Shock Feasibility Trial
NCT ID: NCT05249088
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
98 participants
INTERVENTIONAL
2022-03-01
2023-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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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.
Protocolised reduction of non-resuscitation fluids
* 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)
Usual Care
Participants receive non-resuscitation fluids according to local routines.
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) 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
Interventions
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Protocolised reduction of non-resuscitation fluids
* 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)
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) 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
Eligibility Criteria
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Inclusion Criteria
* 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.
* Inclusion within 12 hours after ICU admission.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Peter Bentzer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Skåne
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Halmstad Hospital
Halmstad, , Sweden
Helsingborg Hospital
Helsingborg, , Sweden
Kristianstad Hospital
Kristianstad, , Sweden
Skåne University Hospital, Lund
Lund, , Sweden
Skåne University Hospital, Malmö
Malmo, , Sweden
Östersund Hospital
Östersund, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
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References
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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.
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.
Related Links
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Markus Harboe Olsen, et al. Protocolised Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients (REDUSE) - a Statistical Analysis Plan for a Multicentre Feasibility Trial. 3.00, Zenodo, Dec. 2022, doi:10.5281/zenodo.7392132.
Other Identifiers
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REDUSE feasibility trial
Identifier Type: -
Identifier Source: org_study_id