Shock, Septic
Conditions
Keywords
shock, septic, hemodynamics, algorithms
Brief summary
A randomized controlled clinical trial to evaluate whether a passive leg raising test to guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain. Patients will be treated according to an algorithm in which the indexed stroke volume (stroke volume related to body surface area) and mean arterial pressure will guide the timing and amount of fluid and the use of inotropic and vasoactive support. Patients will be randomized to either an intervention group in which a passive leg raising test will be made prior to any decision for fluid administration or to a control group where this test is not performed and fluid administration is carried out according to standard of care at the department. Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.
Interventions
PROCEDUREPassive Leg Raising Test
Before decision on fluid administration a passive leg raising test is performed. The results are interpreted according to a treatment protocol. If the test indicates fluid irresponsiveness optimization of circulation will be done with vasopressors or inotropes.
PROCEDUREStandard of care
Patients are treated according to Surviving Sepsis Guidelines
Sponsors
Region Stockholm
Svenska militärläkarföreningen
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients \>18 years admitted to the ICU diagnosed with circulatory shock due to suspected sepsis or pancreatitis. Circulatory shock is defined as MAP\<70 mm Hg or need for norepinephrine despite resuscitation with ≥30 ml/kg of crystalloid fluids.
Exclusion criteria
\> 12 hours have passed after onset of shock. The patient has contraindications for an arterial femoral/axillary line. Elevated ICP. Patients who have had a femoral amputation. Elevated intraabdominal pressure\>20 cm H2O. Suspension criteria: The patient has developed pulmonary oedema during PLR test. Life threatening bleeding. Serious adverse events: Trombosis in arteria femoralis. Death during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight gain | 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | measured within 90 days after inclusion | Number of days spent in the ICU: time and date of discharge from the ICU minus time and date of admission to the ICU. A started but not yet completed day is counted as one. |
| Cumulative fluid balance study day 1,2,3 | Study day 1,2,3 | Fluids in-Fluids out during the study period. |
| 30 day mortality | 30 days from inclusion in the study | Is the patient alive or dead after 30 days? |
| Organ support during ICU stay | ICU-stay | Number of days with mechanical ventilation, vasopressors/inotropic support, CRRT. |
| ICU discharge status | End of ICU stay | Alive or dead at discharge from the ICU? |
Countries
Sweden
Outcome results
None listed