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NOT YET RECRUITING
NCT06118775
NA

Evaluating Dynamic Arterial Elastance in Septic Shock Patients.

Sponsor: Fundación Santa Fe de Bogota

View on ClinicalTrials.gov

Summary

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

Official title: Assessment of the Effectiveness and Safety of Dynamic Arterial Elastance in Weaning Vasopressor Support in Patients with Septic Shock: a Randomized Controlled Clinical Trial At Santa Fé Foundation in Bogotá

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2025-03-01

Completion Date

2026-07-01

Last Updated

2025-02-24

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

EaDyn Weaning Arm:

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 Regardless of the EaDyn value, any patient experiencing a MAP decline below 50 mmHg will be withdrawn from the study.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.

PROCEDURE

PAM Weaning Arm:

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.

Locations (1)

Jorge Iván Alvarad

Bogotá, Colombia