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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Care | Other | Participants receive non-resuscitation fluids according to local routines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocolised reduction of non-resuscitation fluids | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in fluid administration | Total difference in litres of administered fluids between groups | Within the first three days after inclusion (days 0-3) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with sufficient clinical outcome data | Fraction of randomised patients with sufficient data for the following clinical outcomes: all-cause mortality, days alive and free of mechanical ventilation, acute kidney injury, and ischemic events in the ICU (cerebral, cardiac, intestinal or limb ischemia) | Within 90 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All-cause mortality | 90 days after inclusion |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bentzer, MD, PhD | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Sweden | ||||
| Halmstad Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36854601 | Background | 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. | |
| 38760833 |
| Label | URL |
|---|---|
| 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. | View source |
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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.
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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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.
|
| Usual care | Other | Participants receive non-resuscitation fluids according to local routines, with the following stipulations:
|
|
| Proportion of participants assessed by EQ5D-5L and MoCA | Fraction of surviving randomized patients who were assessed by European Quality of Life-5 Dimensions 5- Level questionnaire (EQ5D-5L) and The Montreal Cognitive Assessment (MoCA) | 6 months after inclusion |
| Inclusion of eligible patients | Fraction of all eligible patients who were randomised and consented | During inclusion |
| Protocol violations | Fraction of patients experiencing at least one protocol violation | Within 90 days after inclusion |
| from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days |
| Days alive and free of mechanical ventilation | Days alive and free of mechanical ventilation | Within 90 days after inclusion |
| Cognitive function | Cognitive function measured using MoCA | 6 months after inclusion |
| Health-Related Quality of Life | Health-Related Quality of Life measured using the EQ5D-5L questionnaire | 6 months after inclusion |
| Total volume of non-resuscitation fluids administered | Total volume of non-resuscitation fluids administered | Within the first three days (days 0-3) and within the first five days (days 0-5) after inclusion |
| Renal function | Acute kidney injury stages according to Kidney Disease Improving Global Outcomes [KDIGO] criteria, urea, and days alive and free of renal replacement therapy [RRT] | Within 90 days after inclusion |
| Gastrointestinal function | Days alive with full enteral nutrition | Within 90 days after inclusion |
| Total volume of resuscitation fluids administered | Total volume of resuscitation fluids administered | Within the first three days (days 0-3) and within the first five days (days 0-5) after inclusion |
| Cumulative fluid balance | Cumulative fluid balance (excluding evaporation) | On day 3 and day 5 after inclusion |
| Diuretics administered | Daily dose and type of diuretics administered | Within the first five days (days 0-5) after inclusion |
| Hemodynamic stability | Daily highest dose of noradrenaline, daily lactate, and cardiovascular sequential organ failure assessment [SOFA] score | Within the first five days (days 0-5) after inclusion |
| Ischemic events | Number of patients with one or more ischemic events while in the ICU (cerebral, cardiac, intestinal or limb ischemia) | from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days |
| GOSE score | Glasgow Outcome Scale Extended (GOSE) score | 6 months after inclusion |
| Halmstad |
| Sweden |
| Helsingborg Hospital | Helsingborg | Sweden |
| Kristianstad Hospital | Kristianstad | Sweden |
| Skåne University Hospital, Lund | Lund | Sweden |
| Skåne University Hospital, Malmö | Malmö | Sweden |
| Östersund Hospital | Östersund | Sweden |
| Uppsala University Hospital | Uppsala | Sweden |
| Derived |
| 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |