Assess the effectiveness and safety of using dynamic arterial elastance as a tool for weaning vasopressor support in patients with septic shock, compared to a control group
An open-label, randomized controlled clinical trial will be conducted with two patient groups. Our hypothesis is that using dynamic arterial elastance (EaDyn) as a tool to guide vasopressor weaning can reduce the duration of vasopressor support. Eligible patients will be randomly assigned to either the EaDyn weaning arm or the mean arterial pressure (MAP) weaning arm in a 1:1 ratio. Blinding of participants and investigators will not be possible due to the study's methodology. The analysis will be conducted on an intention-to-treat basis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP \>75 mmHg, a cardiac index (CI) \>2.5 L/min/m², and a lactate level \<2 mmol/L. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg/kg/min every 30 minutes. In the experimental group, vasopressor weaning is guided by the EaDyn value. Weaning can proceed as long as the EaDyn remains at or above 0.90. However, if the value drops below 0.90, the weaning process halts, and the norepinephrine dose is reverted to the last dose where the EaDyn value was ≥ 0.90. Regardless of the EaDyn value, any patient experiencing a MAP decline below 50 mmHg will be withdrawn from the study. Should the MAP range between 50 mmHg and 69 mmHg, a fluid challenge of 250 mL of isotonic crystalloid must be administered before weaning continues.
The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP \>75 mmHg, a cardiac index (CI) \>2.5 L/min/m², and a lactate level \<2 mmol/L. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg/kg/min every 30 minutes. In the control group, vasopressor weaning progresses as long as the MAP remains at or above 70 mmHg. If the MAP falls between 50 and 69 mmHg, preload dependency is reassessed. Upon confirmation, a new fluid challenge is administered; vasopressor weaning halts, and the vasopressor dose reverts to its prior value. The weaning process can continue as long as the patient's MAP remains above 50 mmHg. If the MAP drops below this threshold, the patient exits the study.
Jorge Iván Alvarad
Bogotá, Colombia
Duration of vasopressor support
Defined as the time interval in hours from the initiation of vasopressor support to its discontinuation.
Time frame: 30 days
Cumulative vasopressor dosage.
Total dose of norepinephrine administered from the initiation of vasopressor support to its discontinuation.
Time frame: 30 days
Overall hospital length of stay in days
Length of stay in the hospital in days.
Time frame: 90 days
Overall ICU length of stay in days.
Length of stay in the intensive care unit (ICU) in days.
Time frame: 90 days.
Acute Kidney Injury (AKI).
Proportion of AKI assessed according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines.
Time frame: 90 days.
Mortality
The number or percentage of deaths among patients diagnosed with septic shock during their hospitalization period.
Time frame: 90 days.
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