Reducing non-resuscitation fluids in septic shock patients
Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
NA · Region Skane · NCT06140147
This study is testing if giving less non-resuscitation fluids to adults with septic shock can lead to better recovery compared to the usual treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane (other) |
| Locations | 22 sites (Helsinki and 21 other locations) |
| Trial ID | NCT06140147 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effects of a protocolized reduction in non-resuscitation fluids compared to usual care in adult patients diagnosed with septic shock. The study will assess both the beneficial and harmful outcomes of this restrictive fluid strategy within 12 hours of ICU admission. Participants will be monitored for their response to the intervention, focusing on the need for vasopressors and overall patient stability. The goal is to determine if a more conservative fluid approach can improve patient outcomes in this critical condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who meet the Sepsis 3 criteria for septic shock and require vasopressors within 12 hours of ICU admission.
Not a fit: Patients who are pregnant, have previously participated in this trial, or were screened more than 12 hours after ICU admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of fluid therapy in septic shock patients, potentially reducing complications and enhancing recovery.
How similar studies have performed: While the specific approach of protocolized fluid reduction in septic shock is being tested here, similar studies have shown promise in optimizing fluid management in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki and 21 other locations
- Helsinki University Hospital — Helsinki, Finland (RECRUITING)
- Kuopio University Hospital — Kuopio, Finland (NOT_YET_RECRUITING)
- Tampere University Hospital — Tampere, Finland (NOT_YET_RECRUITING)
- Turku University Hospital — Turku, Finland (NOT_YET_RECRUITING)
- Danderyd Hospital — Danderyd, Sweden (RECRUITING)
- Malar Hospital — Eskilstuna, Sweden (RECRUITING)
- Falun Hospital — Falun, Sweden (RECRUITING)
- Sahlgrenska University Hospital — Gothenburg, Sweden (RECRUITING)
- Östra Hospital — Gothenburg, Sweden (RECRUITING)
- Halmstad Hospital — Halmstad, Sweden (RECRUITING)
- Helsingborg Hospital — Helsingborg, Sweden (RECRUITING)
- Skåne University Hospital, Lund — Lund, Sweden (RECRUITING)
- Skåne University Hospital, Malmö — Malmö, Sweden (RECRUITING)
- Norrtälje Hospital — Norrtälje, Sweden (RECRUITING)
- Örebro University Hospital — Örebro, Sweden (RECRUITING)
- Östersund Hospital — Östersund, Sweden (RECRUITING)
- Södertälje Hospital — Södertälje, Sweden (NOT_YET_RECRUITING)
- Stockholm South General Hospital (SÖS) — Stockholm, Sweden (RECRUITING)
- University Hospital of Umeå — Umeå, Sweden (RECRUITING)
- Uppsala University Hospital — Uppsala, Sweden (RECRUITING)
- Varberg Hospital — Varberg, Sweden (RECRUITING)
- University Hospital of Wales — Cardiff, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Peter Bentzer — Region Skane
- Study coordinator: Peter Bentzer
- Email: Peter.Bentzer@med.lu.se
- Phone: +46 42-4061111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Septic Shock, septic shock