Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Kuopio University Hospital
NOT_YET_RECRUITING
Kuopio
Tampere University Hospital
NOT_YET_RECRUITING
Tampere
Turku University Hospital
NOT_YET_RECRUITING
Turku
Sweden
Danderyd Hospital
RECRUITING
Danderyd
Malar Hospital
RECRUITING
Eskilstuna
Falun Hospital
RECRUITING
Falun
Östra Hospital
RECRUITING
Gothenburg
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Halmstad Hospital
RECRUITING
Halmstad
Helsingborg Hospital
RECRUITING
Helsingborg
Skåne University Hospital, Lund
RECRUITING
Lund
Skåne University Hospital, Malmö
RECRUITING
Malmo
Norrtälje Hospital
RECRUITING
Norrtälje
Örebro University Hospital
RECRUITING
Örebro
Östersund Hospital
RECRUITING
Östersund
Södertälje Hospital
NOT_YET_RECRUITING
Södertälje
Stockholm South General Hospital (SÖS)
RECRUITING
Stockholm
University Hospital of Umeå
RECRUITING
Umeå
Uppsala University Hospital
RECRUITING
Uppsala
Varberg Hospital
RECRUITING
Varberg
United Kingdom
University Hospital of Wales
NOT_YET_RECRUITING
Cardiff
Contact Information
Primary
Peter Bentzer
Peter.Bentzer@med.lu.se
+46 42-4061111
Backup
Jane Fisher
jane.fisher@advansci-research.com
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 1850
Treatments
Experimental: 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.
Other: Usual Care
Participants receive non-resuscitation fluids according to local routines.
Related Therapeutic Areas
Sponsors
Leads: Region Skane