Clinical trial NCT05249088: Protocolized Reduction of Non-resuscitation Fluids vs Usual Care in Septic Shock Feasibility Trial
Official title: Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients: A Multicentre Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shock, Septic
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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.
* Inclusion within 12 hours after ICU admission.

Exclusion Criteria:

* Confirmed or suspected pregnancy

Primary outcomes:
measure: Difference in fluid administration
timeFrame: Within the first three days after inclusion (days 0-3)
Secondary outcomes:
measure: Proportion of participants with sufficient clinical outcome data
timeFrame: Within 90 days after inclusion
measure: Proportion of participants assessed by EQ5D-5L and MoCA
timeFrame: 6 months after inclusion
measure: Inclusion of eligible patients
timeFrame: During inclusion
measure: Protocol violations
timeFrame: Within 90 days after inclusion
Other outcomes:
measure: Mortality
timeFrame: 90 days after inclusion
measure: Complications in the ICU
timeFrame: from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days
measure: Days alive and free of mechanical ventilation
timeFrame: Within 90 days after inclusion
measure: Cognitive function
timeFrame: 6 months after inclusion
measure: Health-Related Quality of Life
timeFrame: 6 months after inclusion
measure: Total volume of non-resuscitation fluids administered
timeFrame: Within the first three days (days 0-3) and within the first five days (days 0-5) after inclusion
measure: Renal function
timeFrame: Within 90 days after inclusion
measure: Gastrointestinal function
timeFrame: Within 90 days after inclusion
measure: Total volume of resuscitation fluids administered
timeFrame: Within the first three days (days 0-3) and within the first five days (days 0-5) after inclusion
measure: Cumulative fluid balance
timeFrame: On day 3 and day 5 after inclusion
measure: Diuretics administered
timeFrame: Within the first five days (days 0-5) after inclusion
measure: Hemodynamic stability
timeFrame: Within the first five days (days 0-5) after inclusion
measure: Ischemic events
timeFrame: from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days
measure: GOSE score
timeFrame: 6 months after inclusion
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Halmstad
country: Sweden
facility: Halmstad Hospital
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Kristianstad
country: Sweden
facility: Kristianstad Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital, Lund
city: Malmö
country: Sweden
facility: Skåne University Hospital, Malmö
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Östersund
country: Sweden
facility: Östersund Hospital
Study officials:
affiliation: Region Skåne
name: Peter Bentzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.