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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EaDyn weaning arm | Experimental | In the EaDyn weaning arm of the study, dynamic arterial elastance (EaDyn) will be utilized as a specialized hemodynamic tool to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. EaDyn, a measure of the relationship between arterial pressure and stroke volume variation over the cardiac cycle, provides valuable insights into vascular tone and cardiac performance |
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| PAM weaning arm | Active Comparator | In the PAM (Mean Arterial Pressure) weaning arm of the study, mean arterial pressure (MAP) will be used as the primary parameter to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. Mean arterial pressure represents the average pressure in the arteries during one cardiac cycle and is a crucial indicator of perfusion to vital organs. Participants in this group will be monitored continuously for their MAP values, allowing real-time assessment of their hemodynamic status. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EaDyn Weaning Arm: | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of vasopressor support | Defined as the time interval in hours from the initiation of vasopressor support to its discontinuation. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative vasopressor dosage. | Total dose of norepinephrine administered from the initiation of vasopressor support to its discontinuation. | 30 days |
| Overall hospital length of stay in days | Length of stay in the hospital in days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jorge Iván Alvarad | Bogotá | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39117412 | Derived | Alvarado Sanchez JI, Montanez-Narino AV, Cardenas-Bolivar YR, Stozitzky-Rios MV, Mora-Salamanca AF. Efficacy and safety of dynamic arterial elastance for weaning vasopressor support in septic shock patients: a randomised controlled trial protocol. BMJ Open. 2024 Aug 7;14(8):e086388. doi: 10.1136/bmjopen-2024-086388. |
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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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An open-label, pragmatic, parallel-group, controlled clinical trial will be conducted with two patient groups. Our hypothesis is that using EaDyn as a hemodynamic tool to guide vasopressor weaning can reduce the duration of vasopressor support. Patients meeting the inclusion criteria will be randomly assigned to one of the two groups using computer-generated random numbers in a 1:1 ratio. In the first group, termed 'EaDyn weaning arm' (EaDyn), dynamic arterial elastance will be used as a tool for vasopressor weaning. In the second group, named 'PAM weaning arm,' mean arterial pressure will be used as the tool for vasopressor weaning. Due to the study's methodological characteristics, blinding of participants and investigators regarding group assignment will not be possible. Lastly, the study will be conducted on an intention-to-treat basis.
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| PAM Weaning Arm: | Procedure | 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. |
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| 90 days |
| Overall ICU length of stay in days. | Length of stay in the intensive care unit (ICU) in days. | 90 days. |
| Acute Kidney Injury (AKI). | Proportion of AKI assessed according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines. | 90 days. |
| Mortality | The number or percentage of deaths among patients diagnosed with septic shock during their hospitalization period. | 90 days. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |